Trial Outcomes & Findings for Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC (NCT NCT04163432)

Last Updated: 2026-05-19

Results Overview

Clinical Benefit is the count of participants who have achieved a CR (Complete Response), PR (Partial Response), or SD (Stable Disease), assessed by RECIST 1.1 response criteria Response Evaluation Criteria in Solid Tumors (RECIST) is a standard measure of how well cancer patients respond to treatment. Possible scores are CR (total disappearance of all target lesions), PR (at least a 30% decrease of the sum of the longest diameter of all target lesions), PD (Progressive Disease; at least a 20% increase of the sum of the longest diameter of all target lesions), and SD (neither a sufficient decrease for PR, or sufficient increase for PD). This outcome measure will report the count of subjects who achieved any Clinical Benefit, Clinical Benefit for 3 months, and Clinical Benefit for 6 months.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

up to 11 months from the start of study treatment

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Chemo-Immuno ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Overall Study STARTED	21	22
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Chemo-Immuno ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Overall Study Death	2	1
Overall Study Disease progression, relapse during active treatment	1	1

Baseline Characteristics

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Chemo-Immuno n=21 Participants ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo n=22 Participants ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=30 Participants	13 Participants n=30 Participants	23 Participants n=60 Participants
Age, Categorical >=65 years	11 Participants n=30 Participants	9 Participants n=30 Participants	20 Participants n=60 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 11.14 • n=30 Participants	64.27 years STANDARD_DEVIATION 10.88 • n=30 Participants	64.19 years STANDARD_DEVIATION 10.88 • n=60 Participants
Sex: Female, Male Female	17 Participants n=30 Participants	12 Participants n=30 Participants	29 Participants n=60 Participants
Sex: Female, Male Male	4 Participants n=30 Participants	10 Participants n=30 Participants	14 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=30 Participants	1 Participants n=30 Participants	3 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=30 Participants	20 Participants n=30 Participants	39 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) White	20 Participants n=30 Participants	18 Participants n=30 Participants	38 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=30 Participants	2 Participants n=30 Participants	3 Participants n=60 Participants
Region of Enrollment United States	21 Participants n=30 Participants	22 Participants n=30 Participants	43 Participants n=60 Participants
Eastern Cooperative Oncology Group (ECOG) 0 Fully active	5 Participants n=30 Participants	12 Participants n=30 Participants	17 Participants n=60 Participants
Eastern Cooperative Oncology Group (ECOG) 1 Restricted	13 Participants n=30 Participants	7 Participants n=30 Participants	20 Participants n=60 Participants
Eastern Cooperative Oncology Group (ECOG) 2 Ambulatory	3 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants
Eastern Cooperative Oncology Group (ECOG) 3 Capable of limited selfcare	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Eastern Cooperative Oncology Group (ECOG) 4 Completely disabled	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants

PRIMARY outcome

Timeframe: up to 11 months from the start of study treatment

Outcome measures

Outcome measures
Measure	Arm A: Chemo-Immuno n=21 Participants ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo n=22 Participants ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Clinical Benefit Achieved Any Clinical Benefit · No	4 Participants	9 Participants
Clinical Benefit Achieved Any Clinical Benefit · Yes	17 Participants	13 Participants
Clinical Benefit Achieved 3 Month Clinical Benefit · Yes	14 Participants	11 Participants
Clinical Benefit Achieved 3 Month Clinical Benefit · No	7 Participants	11 Participants
Clinical Benefit Achieved 6 Month Clinical Benefit · Yes	9 Participants	9 Participants
Clinical Benefit Achieved 6 Month Clinical Benefit · No	12 Participants	13 Participants

SECONDARY outcome

Timeframe: up to 5 years

Adverse events (AEs) and serious adverse events (SAEs) will be collected and assessed by CTCAE, v5.0 for assessment of safety and feasibility.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 34 months from the start of study treatment

Objective Response is the count of participants who have achieved a CR (Complete Response) or PR (Partial Response), assessed by RECIST 1.1 response criteria. Response Evaluation Criteria in Solid Tumors (RECIST) is a standard measure of how well cancer patients respond to treatment. Possible scores are CR (total disappearance of all target lesions), PR (at least a 30% decrease of the sum of the longest diameter of all target lesions), PD (Progressive Disease; at least a 20% increase of the sum of the longest diameter of all target lesions), and SD (neither a sufficient decrease for PR, or sufficient increase for PD). This outcome measure will report the count of subjects who achieved any Objective Response, Objective Response for 3 months, and Objective Response for 6 months.

Outcome measures

Outcome measures
Measure	Arm A: Chemo-Immuno n=21 Participants ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo n=22 Participants ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Objective Response Achieved Any Objective Response · Yes	12 Participants	8 Participants
Objective Response Achieved Any Objective Response · No	9 Participants	14 Participants
Objective Response Achieved 3 Month Objective Response · Yes	9 Participants	7 Participants
Objective Response Achieved 3 Month Objective Response · No	12 Participants	15 Participants
Objective Response Achieved 6 Month Objective Response · Yes	7 Participants	5 Participants
Objective Response Achieved 6 Month Objective Response · No	14 Participants	17 Participants

SECONDARY outcome

Timeframe: up to 5 years

Assessed as the time between trial initiation and documented progression or radiographic imaging.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years from the first dose of study drug

Survival will be assessed as the time from trial initiation until death from any cause, censored at five years. This outcome measure will report the count of participants who are alive, deceased, or unknown at 5 years from the first dose of study drug.

Outcome measures

Outcome measures
Measure	Arm A: Chemo-Immuno n=21 Participants ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo n=22 Participants ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Overall Survival (OS) Deceased	14 Participants	16 Participants
Overall Survival (OS) Unknown - Off Study Due to Early Trial Closure	6 Participants	5 Participants
Overall Survival (OS) Alive	1 Participants	1 Participants

Adverse Events

Arm A: Chemo-Immuno

Serious events: 10 serious events

Other events: 20 other events

Deaths: 14 deaths

Arm B: Immuno-Chemo

Serious events: 9 serious events

Other events: 22 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: Chemo-Immuno n=21 participants at risk ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.	Arm B: Immuno-Chemo n=22 participants at risk ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle. Durvalumab: Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized Pemetrexed: Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2. Carboplatin: Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
Blood and lymphatic system disorders Anemia	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Infections and infestations Appendicitis	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Metabolism and nutrition disorders Anorexia	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Injury, poisoning and procedural complications Fracture	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
General disorders Gait disturbance	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Investigations Lipase increased	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Infections and infestations Lung infection	4.8% 1/21 • Number of events 3 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	22.7% 5/22 • Number of events 8 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Nervous system disorders Myasthenia gravis	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Cardiac disorders Myocardial infarction	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Cardiac disorders Myocarditis	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/21 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	9.1% 2/22 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Investigations Serum amylase increased	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Gastrointestinal disorders Small intestinal obstruction	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Nervous system disorders Stroke	9.5% 2/21 • Number of events 2 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Cardiac disorders Supraventricular tachycardia	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Number of events 1 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.	0.00% 0/22 • Collection of adverse events and serious adverse events began with the first dose of study therapy and ended 90 days after the last dose of study drug (or until a new cancer treatment was initiated), up to 28 months from the start of study treatment. Overall survival was assessed from trial initiation until death from any cause or study closure, up to 5 years from the start of study treatment.