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Closed (no longer recruiting)Last updated: 2 February 2024

This phase III trial is trying to determine if giving neoadjuvant, then adjuvant immunotherapy will prolong survival in patients with early stage non-small cell lung cancerA Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be randomised to receive platinum-based doublet chemotherapy in combination with neoadjuvant and adjuvant nivolumab or a placebo at a specified dose on specified days.

Conditions

This trial is treating patients with non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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