A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02574078

Acronym

CheckMate370

Enrollment

341

Registered

2015-10-12

Start date

2015-11-23

Completion date

2020-04-15

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Detailed description

Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) \*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.

Interventions

DRUGNivolumab

DRUGBevacizumab

DRUGPemetrexed

OTHERBest Supportive Care

Palliative radiation, palliative surgery and/or other best supportive care treatments

DRUGnab-Paclitaxel

DRUGPaclitaxel

DRUGDocetaxel

DRUGGemcitabine

DRUGErlotinib

DRUGCrizotinib

DRUGCarboplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologically confirmed locally advanced or stage IV NSCLC * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 * Tumor tissue sections must be available for biomarker evaluation

Exclusion criteria

* Untreated or active/progressing Central Nervous system (CNS) metastases * Active, known or suspected autoimmune disease * Known history of testing positive for HIV or AIDS * Active or chronic infection of hepatitis B virus or hepatitis C

Design outcomes

Primary

Measure	Time frame	Description
Progression-Free Survival (PFS), Groups A-D Only	up to approximately 48 months	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Overall Survival (OS), Groups A-C Only	up to approximately 60 months	Overall survival (OS) is defined as the time from randomization to the date of death.
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only	up to approximately 60 months	Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.

Secondary

Measure	Time frame	Description
Duration of Response (DOR), Groups A-D Only	up to approximately 48 months	Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Median computed using Kaplan-Meier method.
Progression-Free Survival (PFS), Group E Only	up to approximately 48 months	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Objective Response Rate (ORR), Groups A-E	up to approximately 48 months	Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. Confidence interval based on the Clopper and Pearson method.
Overall Survival (OS), Group D Only	up to approximately 60 months	Overall survival (OS) is defined as the time from randomization to the date of death.

Countries

United States

Participant flow

Pre-assignment details

341 participants were grouped as such: Groups A-D: 328 participants randomized, 314 treated and 14 not treated. Reasons not treated: Group A - 1 no longer met criteria; Group B - 3 withdrew consent, 2 no longer met criteria, 2 other; Group C - 1 no longer met criteria; Group D - 2 withdrew consent, 1 poor/non-compliance, 2 other. Group E: 13 participants treated.

Participants by arm

Arm	Count
Group A, Cohort A, Nivo Nivolumab 240 mg every 2 weeks.	13
Group A, Cohort A, Beva + Nivo Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.	6
Group A, Cohort A, Beva Bevacizumab 15 mg/kg every 3 weeks.	9
Group A, Cohort B, Nivo Nivolumab 240 mg every 2 weeks.	35
Group A, Cohort B, Peme + Nivo Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.	34
Group A, Cohort B, Peme Pemetrexed 500 mg/m\^2 every 3 weeks.	35
Group B, Nivo Nivolumab 240 mg every 2 weeks.	18
Group B, BSC Best Supportive Care (BSC)	17
Group C, Nivo Nivolumab 240 mg every 2 weeks.	26
Group C, ICC Investigator's Choice of Chemotherapy	26
Group D, Nivo + Erlo Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).	53
Group D, Erlo Erlotinib 150 mg QD.	56
Group E Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).	13
Total	341

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010	FG011	FG012
Pre-Treatment Period	Other reasons	0	0	0	0	0	0	2	0	0	0	2	0	0
Pre-Treatment Period	Participant no longer meets study criteria	0	0	0	0	0	1	2	0	1	0	0	0	0
Pre-Treatment Period	Participant withdrew consent	0	0	0	0	0	0	0	3	0	0	2	0	0
Pre-Treatment Period	Poor/non-compliance	0	0	0	0	0	0	0	0	0	0	0	1	0
Treatment Period	Administrative reason by Sponsor	0	1	0	0	0	0	1	0	0	0	0	0	3
Treatment Period	Adverse event unrelated to drug	0	0	1	0	2	3	0	0	1	2	4	1	0
Treatment Period	Death	2	0	0	0	1	1	1	1	7	1	0	2	1
Treatment Period	Disease progression	6	4	7	18	16	26	5	9	8	5	20	29	2
Treatment Period	Lost to Follow-up	0	0	0	0	0	0	0	0	0	1	0	1	0
Treatment Period	Maximum clinical benefit	0	0	0	0	0	0	0	0	0	1	0	0	0
Treatment Period	Other reasons	1	0	1	3	3	1	2	1	3	1	1	3	1
Treatment Period	Participant no longer meets criteria	0	0	0	0	1	0	0	0	0	1	1	1	0
Treatment Period	Participant request to stop drug	0	0	0	2	4	0	1	0	3	2	2	4	1
Treatment Period	Participant withdrew consent	0	0	0	0	1	1	0	1	0	2	1	4	1
Treatment Period	Study drug toxicity	1	1	0	5	3	1	2	0	2	1	16	2	4

Baseline characteristics

Characteristic	Total	Group A, Cohort A, Nivo	Group A, Cohort A, Beva + Nivo	Group A, Cohort A, Beva	Group A, Cohort B, Nivo	Group A, Cohort B, Peme + Nivo	Group A, Cohort B, Peme	Group B, Nivo	Group B, BSC	Group C, Nivo	Group C, ICC	Group D, Nivo + Erlo	Group D, Erlo	Group E
Age, Customized >= 65 and < 75 years old	141 Participants	4 Participants	2 Participants	3 Participants	15 Participants	13 Participants	15 Participants	10 Participants	9 Participants	13 Participants	11 Participants	21 Participants	24 Participants	1 Participants
Age, Customized < 65 years old	119 Participants	8 Participants	2 Participants	1 Participants	15 Participants	14 Participants	15 Participants	5 Participants	4 Participants	3 Participants	4 Participants	21 Participants	20 Participants	7 Participants
Age, Customized >= 75 years old	81 Participants	1 Participants	2 Participants	5 Participants	5 Participants	7 Participants	5 Participants	3 Participants	4 Participants	10 Participants	11 Participants	11 Participants	12 Participants	5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants	5 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	320 Participants	13 Participants	6 Participants	8 Participants	34 Participants	31 Participants	32 Participants	17 Participants	16 Participants	26 Participants	23 Participants	50 Participants	51 Participants	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	22 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	9 Participants	10 Participants	1 Participants
Race/Ethnicity, Customized Black or African American	22 Participants	3 Participants	0 Participants	1 Participants	3 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	2 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Other	7 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	288 Participants	9 Participants	6 Participants	7 Participants	31 Participants	32 Participants	34 Participants	16 Participants	15 Participants	23 Participants	21 Participants	41 Participants	43 Participants	10 Participants
Sex: Female, Male Female	185 Participants	6 Participants	4 Participants	4 Participants	21 Participants	13 Participants	21 Participants	11 Participants	9 Participants	12 Participants	14 Participants	33 Participants	31 Participants	6 Participants
Sex: Female, Male Male	156 Participants	7 Participants	2 Participants	5 Participants	14 Participants	21 Participants	14 Participants	7 Participants	8 Participants	14 Participants	12 Participants	20 Participants	25 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk
deaths Total, all-cause mortality	8 / 13	4 / 6	6 / 9	24 / 35	23 / 34	24 / 34	5 / 14	9 / 14	23 / 25	18 / 26	20 / 49	25 / 55	7 / 13
other Total, other adverse events	12 / 13	6 / 6	9 / 9	35 / 35	32 / 34	33 / 34	13 / 14	13 / 14	22 / 25	25 / 26	49 / 49	55 / 55	13 / 13
serious Total, serious adverse events	6 / 13	1 / 6	5 / 9	15 / 35	16 / 34	14 / 34	5 / 14	7 / 14	23 / 25	7 / 26	25 / 49	17 / 55	8 / 13

Outcome results

Primary

Overall Survival (OS), Groups A-C Only

Overall survival (OS) is defined as the time from randomization to the date of death.

Time frame: up to approximately 60 months

Population: All randomized participants in Groups A-C only

Arm	Measure	Value (MEDIAN)
Group A, Cohort A, Nivo	Overall Survival (OS), Groups A-C Only	20.0 Months
Group A, Cohort A, Beva + Nivo	Overall Survival (OS), Groups A-C Only	30.8 Months
Group A, Cohort A, Beva	Overall Survival (OS), Groups A-C Only	18.1 Months
Group A, Cohort B, Nivo	Overall Survival (OS), Groups A-C Only	28.9 Months
Group A, Cohort B, Peme + Nivo	Overall Survival (OS), Groups A-C Only	17.4 Months
Group A, Cohort B, Peme	Overall Survival (OS), Groups A-C Only	18.4 Months
Group B, Nivo	Overall Survival (OS), Groups A-C Only	NA Months
Group B, BSC	Overall Survival (OS), Groups A-C Only	13.6 Months
Group C, Nivo	Overall Survival (OS), Groups A-C Only	3.9 Months
Group C, ICC	Overall Survival (OS), Groups A-C Only	15.8 Months

p-value: 0.995195% CI: [0.35, 2.91]Unstratified log-rank

p-value: 0.832195% CI: [0.25, 3.1]Unstratified log-rank

p-value: 0.293895% CI: [0.41, 1.31]Unstratified log-rank

p-value: 0.481995% CI: [0.46, 1.45]Unstratified log-rank

p-value: 0.024195% CI: [0.11, 0.91]Unstratified log-rank

p-value: 0.140195% CI: [0.85, 2.95]Unstratified log-rank

Primary

Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only

Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.

Time frame: up to approximately 60 months

Population: All treated participants in Group E only

Arm	Measure	Value (NUMBER)
Group A, Cohort A, Nivo	Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only	38.5 Percentage of participants

Primary

Progression-Free Survival (PFS), Groups A-D Only

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.

Time frame: up to approximately 48 months

Population: All randomized participants in Groups A-D only

Arm	Measure	Value (MEDIAN)
Group A, Cohort A, Nivo	Progression-Free Survival (PFS), Groups A-D Only	15.0 Months
Group A, Cohort A, Beva + Nivo	Progression-Free Survival (PFS), Groups A-D Only	6.7 Months
Group A, Cohort A, Beva	Progression-Free Survival (PFS), Groups A-D Only	6.0 Months
Group A, Cohort B, Nivo	Progression-Free Survival (PFS), Groups A-D Only	5.9 Months
Group A, Cohort B, Peme + Nivo	Progression-Free Survival (PFS), Groups A-D Only	8.1 Months
Group A, Cohort B, Peme	Progression-Free Survival (PFS), Groups A-D Only	5.0 Months
Group B, Nivo	Progression-Free Survival (PFS), Groups A-D Only	9.6 Months
Group B, BSC	Progression-Free Survival (PFS), Groups A-D Only	2.3 Months
Group C, Nivo	Progression-Free Survival (PFS), Groups A-D Only	2.7 Months
Group C, ICC	Progression-Free Survival (PFS), Groups A-D Only	6.7 Months
Group D, Nivo + Erlo	Progression-Free Survival (PFS), Groups A-D Only	11.0 Months
Group D, Erlo	Progression-Free Survival (PFS), Groups A-D Only	11.0 Months

p-value: 0.50595% CI: [0.24, 2.03]Unstratified log-rank

p-value: 0.628495% CI: [0.22, 2.54]Unstratified log-rank

p-value: 0.198895% CI: [0.4, 1.22]Unstratified log-rank

p-value: 0.272295% CI: [0.42, 1.28]Unstratified log-rank

p-value: 0.054495% CI: [0.17, 1.04]Unstratified log-rank

p-value: 0.044295% CI: [1, 4.16]Unstratified log-rank

p-value: 0.548995% CI: [0.5, 1.45]Log Rank

Secondary

Duration of Response (DOR), Groups A-D Only

Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Median computed using Kaplan-Meier method.

Time frame: up to approximately 48 months

Population: All responders (participants with objective response of CR or PR) in Groups A-D only.

Arm	Measure	Value (MEDIAN)
Group A, Cohort A, Nivo	Duration of Response (DOR), Groups A-D Only	12.780 months
Group A, Cohort A, Beva + Nivo	Duration of Response (DOR), Groups A-D Only	NA months
Group A, Cohort A, Beva	Duration of Response (DOR), Groups A-D Only	17.084 months
Group A, Cohort B, Nivo	Duration of Response (DOR), Groups A-D Only	12.912 months
Group A, Cohort B, Peme + Nivo	Duration of Response (DOR), Groups A-D Only	8.542 months
Group A, Cohort B, Peme	Duration of Response (DOR), Groups A-D Only	14.982 months
Group B, Nivo	Duration of Response (DOR), Groups A-D Only	NA months
Group B, BSC	Duration of Response (DOR), Groups A-D Only	NA months
Group C, Nivo	Duration of Response (DOR), Groups A-D Only	3.877 months
Group C, ICC	Duration of Response (DOR), Groups A-D Only	2.940 months
Group D, Nivo + Erlo	Duration of Response (DOR), Groups A-D Only	8.805 months
Group D, Erlo	Duration of Response (DOR), Groups A-D Only	10.152 months

Secondary

Objective Response Rate (ORR), Groups A-E

Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. Confidence interval based on the Clopper and Pearson method.

Time frame: up to approximately 48 months

Population: All randomized (Groups A-D) and treated (Group E) participants with at least one lesion at baseline

Arm	Measure	Value (NUMBER)
Group A, Cohort A, Nivo	Objective Response Rate (ORR), Groups A-E	23.1 Percentage of participants
Group A, Cohort A, Beva + Nivo	Objective Response Rate (ORR), Groups A-E	16.7 Percentage of participants
Group A, Cohort A, Beva	Objective Response Rate (ORR), Groups A-E	12.5 Percentage of participants
Group A, Cohort B, Nivo	Objective Response Rate (ORR), Groups A-E	29.4 Percentage of participants
Group A, Cohort B, Peme + Nivo	Objective Response Rate (ORR), Groups A-E	21.2 Percentage of participants
Group A, Cohort B, Peme	Objective Response Rate (ORR), Groups A-E	3.1 Percentage of participants
Group B, Nivo	Objective Response Rate (ORR), Groups A-E	18.8 Percentage of participants
Group B, BSC	Objective Response Rate (ORR), Groups A-E	5.9 Percentage of participants
Group C, Nivo	Objective Response Rate (ORR), Groups A-E	20.8 Percentage of participants
Group C, ICC	Objective Response Rate (ORR), Groups A-E	15.4 Percentage of participants
Group D, Nivo + Erlo	Objective Response Rate (ORR), Groups A-E	64.7 Percentage of participants
Group D, Erlo	Objective Response Rate (ORR), Groups A-E	62.5 Percentage of participants
Group E	Objective Response Rate (ORR), Groups A-E	23.1 Percentage of participants

Secondary

Overall Survival (OS), Group D Only

Overall survival (OS) is defined as the time from randomization to the date of death.

Time frame: up to approximately 60 months

Population: All randomized participants in Group D only

Arm	Measure	Value (MEDIAN)
Group A, Cohort A, Nivo	Overall Survival (OS), Group D Only	NA months
Group A, Cohort A, Beva + Nivo	Overall Survival (OS), Group D Only	34.8 months

p-value: 0.286295% CI: [0.4, 1.31]Log Rank

Secondary

Progression-Free Survival (PFS), Group E Only

Time frame: up to approximately 48 months

Population: All treated participants in Group E only

Arm	Measure	Value (MEDIAN)
Group A, Cohort A, Nivo	Progression-Free Survival (PFS), Group E Only	9.63 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Overall Survival (OS), Groups A-C Only

Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only

Progression-Free Survival (PFS), Groups A-D Only

Duration of Response (DOR), Groups A-D Only

Objective Response Rate (ORR), Groups A-E

Overall Survival (OS), Group D Only

Progression-Free Survival (PFS), Group E Only