A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: nab-Paclitaxel; Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Erlotinib; Other: Best Supportive Care; Drug: Carboplatin; Drug: Crizotinib; Drug: Bevacizumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02574078

CA209-370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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341 participants in 10 patient groups

Group A Nivolumab

Experimental group

Description:

Opdivo specified dose on specified days

Treatment:

Drug: Nivolumab

Group A Nivolumab + SOC maintenance therapy

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: Bevacizumab

Drug: Pemetrexed

Group A SOC maintenance therapy

Active Comparator group

Description:

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

Treatment:

Drug: Bevacizumab

Drug: Pemetrexed

Group B Nivolumab

Experimental group

Description:

Opdivo specified dose on specified days

Treatment:

Drug: Nivolumab

Group B Best supportive care

Other group

Description:

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

Treatment:

Other: Best Supportive Care

Group C Investigator's choice chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: Gemcitabine

Drug: Paclitaxel

Drug: nab-Paclitaxel

Drug: Docetaxel

Group C Nivolumb

Experimental group

Description:

Opdivo specified dose on specified days

Treatment:

Drug: Nivolumab

Group D Erlotinib

Active Comparator group

Description:

Erlotinib specified dose on specified days

Treatment:

Drug: Erlotinib

Group D Nivolumab + Erlotinib

Experimental group

Description:

Opdivo/Erlotnib specified dose on specified days

Treatment:

Drug: Nivolumab

Drug: Erlotinib

Group E Nivolumab + Crizotinib

Experimental group

Description:

Opdivo/Crizotinib specified dose on specified days

Treatment:

Drug: Nivolumab

Drug: Crizotinib