A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Docetaxel; Drug: Cisplatin; Drug: Pemetrexed; Biological: Ipilimumab; Drug: Carboplatin; Drug: Vinorelbine; Biological: Nivolumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02998528

2016-003536-21 (EudraCT Number)

CA209-816

Details and patient eligibility

About

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
• Lung function capacity capable of tolerating the proposed lung surgery
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Available tissue of primary lung tumor

Exclusion criteria

• Presence of locally advanced, inoperable or metastatic disease
• Participants with active, known or suspected autoimmune disease
• Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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505 participants in 3 patient groups

Platinum doublet chemotherapy

Active Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Paclitaxel

Drug: Vinorelbine

Drug: Carboplatin

Drug: Pemetrexed

Drug: Cisplatin

Drug: Docetaxel

Drug: Gemcitabine

Nivolumab plus platinum doublet chemotherapy

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: Paclitaxel

Biological: Nivolumab

Drug: Carboplatin

Drug: Pemetrexed

Drug: Cisplatin

Drug: Gemcitabine

Nivolumab plus Ipilimumab

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Nivolumab

Biological: Ipilimumab