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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) logo

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

Trial documents
1

Trial contacts and locations

110

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Data sourced from clinicaltrials.gov

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