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Completed

NCT Number: NCT02574078

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alabama Oncology, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

Other names: Opdivo

Bevacizumab

Drug

Pemetrexed

Drug

Best supportive care

Other

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

Nab-paclitaxel

Drug

paclitaxel

Drug

docetaxel

Drug

Gemcitabine

Drug

Erlotinib

Drug

Crizotinib

Drug

carboplatin

Drug

Primary outcomes

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

    Time frame: 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.

  2. Overall Survival (OS), Groups A-C Only

    Time frame: up to approximately 60 months

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

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Objective Response Rate (ORR), Groups A-E

    Time frame: 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.

  3. Overall Survival (OS), Group D Only

    Time frame: up to approximately 60 months

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

  4. Progression-Free Survival (PFS), Group E Only

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Acronym: CheckMate370

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2015
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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