Trial Outcomes & Findings for Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO) (NCT NCT04776447)

Last Updated: 2026-07-22

Results Overview

To assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.PFS is defined as the time from inclusion until objective tumor progression or death. The efficacy at 12 months is calculated as the percentage of patients who have not shown disease progression during the first 12 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.

Results posted on

2026-07-22

Participant Flow

ITT population

Participant milestones

Participant milestones
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
Overall Study STARTED	38
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PD-L1 testing was only performed in 27 patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 Participants Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
Age, Continuous	66.8 years n=38 Participants
Sex: Female, Male Female	11 Participants n=38 Participants
Sex: Female, Male Male	27 Participants n=38 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=38 Participants
Race (NIH/OMB) Asian	0 Participants n=38 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=38 Participants
Race (NIH/OMB) Black or African American	0 Participants n=38 Participants
Race (NIH/OMB) White	38 Participants n=38 Participants
Race (NIH/OMB) More than one race	0 Participants n=38 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=38 Participants
Smoking habit Non-smoker (≤ 100 cigarettes/lifetime)	1 Participants n=38 Participants
Smoking habit Former smoker (≥ 1 year without smoking)	24 Participants n=38 Participants
Smoking habit Smoker	13 Participants n=38 Participants
ECOG at diagnosis 0	18 Participants n=38 Participants
ECOG at diagnosis 1	20 Participants n=38 Participants
PD-L1 status at diagnosis Negative	11 Participants n=27 Participants • PD-L1 testing was only performed in 27 patients.
PD-L1 status at diagnosis Positive: 1-49%	10 Participants n=27 Participants • PD-L1 testing was only performed in 27 patients.
PD-L1 status at diagnosis Positive: ≥ 50%	6 Participants n=27 Participants • PD-L1 testing was only performed in 27 patients.

PRIMARY outcome

Timeframe: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.

Population: Median of patients that did not have a Progression Disease

Outcome measures

Outcome measures
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 Participants Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
To Assess the Efficacy of the Treatment in Terms of the Progression Free Survival (PFS) at 12 Months	68.4 % of participants Interval 51.1 to 80.7

SECONDARY outcome

Timeframe: From the date of randomization to the date of last follow up, assessed up to 36 months

To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 Participants Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
To Evaluate the Overall Response Rate (ORR) of the Treatment Complete responses (CR)	5 Participants
To Evaluate the Overall Response Rate (ORR) of the Treatment partial responses (PR)	22 Participants
To Evaluate the Overall Response Rate (ORR) of the Treatment Stable disease (SD)	7 Participants
To Evaluate the Overall Response Rate (ORR) of the Treatment progressive disease (PD)	3 Participants
To Evaluate the Overall Response Rate (ORR) of the Treatment Not evaluable	1 Participants

SECONDARY outcome

Timeframe: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.

To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment.

Outcome measures

Outcome measures
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 Participants Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
To Evaluate the Overall Survival (OS) Rate Overall survival at 12 months	86.8 % of participants Interval 71.2 to 94.3
To Evaluate the Overall Survival (OS) Rate Overall survival at 24 months	60.5 % of participants Interval 43.3 to 74.0

Adverse Events

Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy

Serious events: 21 serious events

Other events: 38 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 participants at risk Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
Renal and urinary disorders Acute kidney injury	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Infections and infestations Bilateral pneumonia	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Respiratory, thoracic and mediastinal disorders Bronchospam	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Gastrointestinal disorders Diarrhea	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
General disorders Edema of lower extremities	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Nervous system disorders Encephalitis	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Febrile neutropenia	10.5% 4/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
General disorders General physical health deterioration	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Immune system disorders Immunne-mediated hepatitis	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Nervous system disorders Cerebral ischaemia	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Pancytopenia	7.9% 3/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Infections and infestations Perianal abscess	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Infections and infestations Pneumocystis jiroveci pneumonia	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Infections and infestations Pneumonia	10.5% 4/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Infections and infestations Respiratory infection	7.9% 3/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Renal and urinary disorders Urosepsis	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.

Other adverse events

Other adverse events
Measure	Experimental: Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy n=38 participants at risk Induction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months.
Blood and lymphatic system disorders Lymphocyte count decrease	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
General disorders Fatigue	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Anemia	15.8% 6/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Neutrophil count decreased	26.3% 10/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Platelet count decreased	7.9% 3/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Lymphocyte count decreased	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Gastrointestinal disorders Diarrhea	5.3% 2/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Febrile neutropenia	13.2% 5/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Nervous system disorders Peripheral sensory neuropathy	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Nervous system disorders Peripheral motor neuropathy	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Skin and subcutaneous tissue disorders Eczema	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Gastrointestinal disorders Mucositis oral	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.
Blood and lymphatic system disorders Pancytopenia	2.6% 1/38 • Adverse events and SAEs must be recorded and followed from the day of the patient Informed consent signature up to 30 days from last dose of administration, up to 19 months. Deaths were measured from the date of inclusion up to 30 months.

Additional Information

Eva Pereira

Fun

Phone: +34 934302006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place