NCT02574078|CompletedPhase 1ResultsDMC

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

CheckMate370

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)

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

CA209-370

Study Type

interventional

Target

341

Locations

1 country

Sites

133

Timeline

RegisteredOct 2015

StartedNov 2015

CompletionApr 2020

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

341

participants targeted

Target at P75+ for phase_1 nonsmall-cell-lung-cancer

Timeline

Completed

Started Nov 2015

Typical duration for phase_1 nonsmall-cell-lung-cancer

Geographic Reach

1 country

133 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

First Submitted

Initial submission to the registry

October 9, 2015

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed

1 month until next milestone

Study Start

First participant enrolled

November 23, 2015

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 6, 2021

Completed

Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

4.4 years

First QC Date

October 9, 2015

Results QC Date

March 15, 2021

Last Update Submit

April 12, 2021

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

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.
up to approximately 48 months
Overall Survival (OS), Groups A-C Only
Overall survival (OS) is defined as the time from randomization to the date of death.
up to approximately 60 months
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.
up to approximately 60 months

Secondary Outcomes (4)

Duration of Response (DOR), Groups A-D Only
up to approximately 48 months
Objective Response Rate (ORR), Groups A-E
up to approximately 48 months
Overall Survival (OS), Group D Only
up to approximately 60 months
Progression-Free Survival (PFS), Group E Only
up to approximately 48 months

Study Arms (10)

Group A Nivolumab

EXPERIMENTAL

Opdivo specified dose on specified days

Drug: Nivolumab

Group A Nivolumab + SOC maintenance therapy

EXPERIMENTAL

Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days

Drug: NivolumabDrug: BevacizumabDrug: Pemetrexed

Group A SOC maintenance therapy

ACTIVE COMPARATOR

Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days

Drug: BevacizumabDrug: Pemetrexed

Group B Nivolumab

EXPERIMENTAL

Opdivo specified dose on specified days

Drug: Nivolumab

Group B Best supportive care

OTHER

Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery

Other: Best Supportive Care

Group C Investigator's choice chemotherapy

ACTIVE COMPARATOR

Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days

Drug: PemetrexedDrug: nab-PaclitaxelDrug: PaclitaxelDrug: DocetaxelDrug: GemcitabineDrug: Carboplatin

Group C Nivolumb

EXPERIMENTAL

Opdivo specified dose on specified days

Drug: Nivolumab

Group D Erlotinib

ACTIVE COMPARATOR

Erlotinib specified dose on specified days

Drug: Erlotinib

Group D Nivolumab + Erlotinib

EXPERIMENTAL

Opdivo/Erlotnib specified dose on specified days

Drug: NivolumabDrug: Erlotinib

Group E Nivolumab + Crizotinib

EXPERIMENTAL

Opdivo/Crizotinib specified dose on specified days

Drug: NivolumabDrug: Crizotinib

Interventions

NivolumabDRUG

Also known as: Opdivo

Group A NivolumabGroup A Nivolumab + SOC maintenance therapyGroup B NivolumabGroup C NivolumbGroup D Nivolumab + ErlotinibGroup E Nivolumab + Crizotinib

BevacizumabDRUG

Group A Nivolumab + SOC maintenance therapyGroup A SOC maintenance therapy

PemetrexedDRUG

Group A Nivolumab + SOC maintenance therapyGroup A SOC maintenance therapyGroup C Investigator's choice chemotherapy

Best Supportive CareOTHER

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

Group B Best supportive care

nab-PaclitaxelDRUG