Trial Outcomes & Findings for An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer (NCT NCT05500092)

Last Updated: 2026-08-27

Results Overview

Complete pathological response (CPR) rate observed after neoadjuvant therapy and surgical resection. Complete pathological response will be defined as the absence of tumor cells in the resected specimen upon histopathological examination and will be reported as the number/percentage of participants who had complete pathological response. Results will be summarized for each study arm.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

After 3 cycles. Each cycle is defined as 3 weeks

Results posted on

2026-08-27

Participant Flow

Among 38 operable/resectable patients diagnosed with the appropriate stage of non-small cell lung cancer (NSCLC) during study activation, 17 patients were enrolled.

Participant milestones

Participant milestones
Measure	Nivolumab + Platinum Doublet Chemotherapy All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) Stereotactic Body Radiation Therapy (SBRT) will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab + Platinum Doublet Chemotherapy n=9 Participants All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) n=8 Participants SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Total n=17 Participants Total of all reporting groups
Age, Continuous	69 years n=31 Participants	62 years n=49 Participants	66 years n=80 Participants
Sex: Female, Male Female	6 Participants n=31 Participants	3 Participants n=49 Participants	9 Participants n=80 Participants
Sex: Female, Male Male	3 Participants n=31 Participants	5 Participants n=49 Participants	8 Participants n=80 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=31 Participants	2 Participants n=49 Participants	3 Participants n=80 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=31 Participants	4 Participants n=49 Participants	12 Participants n=80 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	2 Participants n=49 Participants	2 Participants n=80 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants
Race (NIH/OMB) Black or African American	5 Participants n=31 Participants	3 Participants n=49 Participants	8 Participants n=80 Participants
Race (NIH/OMB) White	3 Participants n=31 Participants	1 Participants n=49 Participants	4 Participants n=80 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	0 Participants n=49 Participants	0 Participants n=80 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=31 Participants	4 Participants n=49 Participants	5 Participants n=80 Participants
Region of Enrollment United States	9 participants n=31 Participants	8 participants n=49 Participants	17 participants n=80 Participants
Distressed Communities Index (DCI) score	70.0 percentage n=31 Participants	83.1 percentage n=49 Participants	76.2 percentage n=80 Participants
Comorbidities Coronary Artery Disease (CAD)	0 Participants n=31 Participants	4 Participants n=49 Participants	4 Participants n=80 Participants
Comorbidities Hypertension (HTN)	6 Participants n=31 Participants	7 Participants n=49 Participants	13 Participants n=80 Participants
Comorbidities Diabetes Mellitus Type 2 (DMII)	1 Participants n=31 Participants	3 Participants n=49 Participants	4 Participants n=80 Participants
Comorbidities Renal Insufficiency	1 Participants n=31 Participants	1 Participants n=49 Participants	2 Participants n=80 Participants
Comorbidities Chronic Obstructive Pulmonary Disease (COPD)	3 Participants n=31 Participants	1 Participants n=49 Participants	4 Participants n=80 Participants
Comorbidities Immune Disorder	1 Participants n=31 Participants	0 Participants n=49 Participants	1 Participants n=80 Participants
Clinical Stage of Non-small Cell Lung Cancer (NSCLC) Stage IIA	2 Participants n=31 Participants	0 Participants n=49 Participants	2 Participants n=80 Participants
Clinical Stage of Non-small Cell Lung Cancer (NSCLC) Stage IIB	2 Participants n=31 Participants	3 Participants n=49 Participants	5 Participants n=80 Participants
Clinical Stage of Non-small Cell Lung Cancer (NSCLC) Stage IIIA	3 Participants n=31 Participants	4 Participants n=49 Participants	7 Participants n=80 Participants
Clinical Stage of Non-small Cell Lung Cancer (NSCLC) Stage IIIB	2 Participants n=31 Participants	1 Participants n=49 Participants	3 Participants n=80 Participants
Programmed death-ligand 1 (PD-L1) Tumor Protection Score (TPS): PD-L1 TPS PD-L1 TPS: <1%	2 Participants n=31 Participants	1 Participants n=49 Participants	3 Participants n=80 Participants
Programmed death-ligand 1 (PD-L1) Tumor Protection Score (TPS): PD-L1 TPS PD-L1 TPS: 1-50%	2 Participants n=31 Participants	5 Participants n=49 Participants	7 Participants n=80 Participants
Programmed death-ligand 1 (PD-L1) Tumor Protection Score (TPS): PD-L1 TPS PD-L1 TPS: > 50%	5 Participants n=31 Participants	2 Participants n=49 Participants	7 Participants n=80 Participants
Pulmonary Function Testing FEV1	82 percentage n=31 Participants	82 percentage n=49 Participants	82 percentage n=80 Participants
Pulmonary Function Testing DLCO	88 percentage n=31 Participants	68 percentage n=49 Participants	79 percentage n=80 Participants

PRIMARY outcome

Timeframe: After 3 cycles. Each cycle is defined as 3 weeks

Outcome measures

Outcome measures
Measure	Nivolumab + Platinum Doublet Chemotherapy n=9 Participants All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) n=8 Participants SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy
Complete Pathological Response	3 Participants	4 Participants

SECONDARY outcome

Timeframe: After 3 cycles. Each cycle is defined as 3 weeks

Major Pathological Response (MPR) rate will be assessed. MPR will be defined as ≤ 10% residual viable tumor cells, at the time of surgical resection, in the primary tumor and resected lymph nodes, as assessed by local pathology laboratory. MPR rate and corresponding 95% Clopper-Pearson confidence intervals will be calculated for each treatment arm.

Outcome measures

Outcome measures
Measure	Nivolumab + Platinum Doublet Chemotherapy n=9 Participants All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) n=8 Participants SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy
Major Pathological Response	4 Participants	5 Participants

SECONDARY outcome

Timeframe: From the time of enrollment up to approximately 5 years

Event free survival (EFS) will be defined as survival without evidence of documented disease progression, per RECIST v1.1 criteria, that precludes surgery for local or distant disease recurrence. Results will be summarized by study arm.

Outcome measures

Outcome data not reported

Adverse Events

Nivolumab + Platinum Doublet Chemotherapy

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab + Platinum Doublet Chemotherapy n=9 participants at risk All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) n=8 participants at risk SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy
Nervous system disorders Syncope	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Vascular disorders Hematoma	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Blood and lymphatic system disorders Anemia	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Infections and infestations Pneumonia	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Non-cardiac Chest pain	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.

Other adverse events

Additional Information

Dr. Brendon Stiles

Montefiore Medical Center

Phone: 718-920-5732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Nivolumab + Platinum Doublet Chemotherapy n=9 participants at risk All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities. Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy	Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) n=8 participants at risk SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion Nivolumab: Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor (8gy x 3): sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor Platinum Doublet: Standard of care doublet platinum therapy
Gastrointestinal disorders Nausea	44.4% 4/9 • Number of events 6 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	62.5% 5/8 • Number of events 5 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Nervous system disorders Neuralgia	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Fatigue	77.8% 7/9 • Number of events 11 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	75.0% 6/8 • Number of events 7 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Esophagitis	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	25.0% 2/8 • Number of events 2 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Psychiatric disorders Insomnia	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Edema limbs	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 3/9 • Number of events 4 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	37.5% 3/8 • Number of events 4 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Respiratory, thoracic and mediastinal disorders Dyspnea	44.4% 4/9 • Number of events 5 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Constipation	33.3% 3/9 • Number of events 3 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	25.0% 2/8 • Number of events 2 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Oral pain	0.00% 0/9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Nervous system disorders Peripheral sensory neuropathy	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Number of events 2 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Respiratory, thoracic and mediastinal disorders Sore throat	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Mucositis oral	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Gastrointestinal disorders Gastroesophageal reflux disease (GERD)	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Vascular disorders Phlebitis	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Gait disturbance	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Chest pain	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Renal and urinary disorders Urinary frequency	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Renal and urinary disorders Urinary urgency	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Musculoskeletal and connective tissue disorders Arthritis	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations White blood cell (WBC) decreased	22.2% 2/9 • Number of events 9 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Neutrophil count decreased	11.1% 1/9 • Number of events 6 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	12.5% 1/8 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Blood and lymphatic system disorders Anemia	22.2% 2/9 • Number of events 2 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Platelet count decreased	11.1% 1/9 • Number of events 3 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Lymphocyte count decreased	11.1% 1/9 • Number of events 7 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Aspartate aminotransferase increased	22.2% 2/9 • Number of events 5 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Number of events 4 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
General disorders Pain	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Musculoskeletal and connective tissue disorders Chest wall pain	33.3% 3/9 • Number of events 4 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Investigations Alkaline phosphatase increased	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.
Nervous system disorders Dizziness	11.1% 1/9 • Number of events 1 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.	0.00% 0/8 • From date of informed consent through 90 days after the last dose of nivolumab (or until initiation of new anticancer therapy, whichever occurred first), up to approximately 5 months total.