A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Biological: Nivolumab; Drug: Cisplatin; Drug: Placebo; Drug: Pemetrexed; Drug: Docetaxel; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04025879

CA209-77T

2019-000262-38 (EudraCT Number)

Details and patient eligibility

About

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Enrollment: 461 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
• No brain metastasis
• Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
• Ability to provide surgical or biopsy tumor tissue for biomarkers
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion criteria

• Participants with an active, known or suspected autoimmune disease
• Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
• Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
• Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

461 participants in 2 patient groups, including a placebo group

Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Docetaxel

Drug: Carboplatin

Drug: Pemetrexed

Drug: Cisplatin

Biological: Nivolumab

Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.

Placebo Comparator group

Treatment:

Drug: Paclitaxel

Drug: Docetaxel

Drug: Carboplatin

Drug: Pemetrexed

Drug: Placebo

Drug: Cisplatin