At a glance

ClinicalIndex Comparison Record

Phase 3Active· 461 enrolled

Drug / intervention

Nivolumab +6 morebiological

Likely dose

Nivolumab specified dose on specified days with neoadjuvant chemotherapy (carboplatin, cisplatin, paclitaxel, pemetrexed, and/or docetaxel)AI-extracted

Key inclusion· 4

✓Suspected or histologically confirmed Stage IIA (>4 cm) to IIIB (T3N2) NSCLC that is resectable
✓Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
✓Able to provide surgical or biopsy tumor tissue for biomarkers
✓ECOG Performance Status ≤1

Key exclusion· 5

✕Brain metastases present
✕Active, known or suspected autoimmune disease
✕Positive test for hepatitis B, hepatitis C, or HIV
✕Prior anti-cancer treatment including cytotoxic, IO, targeted agents, or radiotherapy for NSCLC

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04025879

NCT04025879Phase 3Active

Compare CT.gov

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

Bristol-Myers Squibb·interventional·Posted Jul 19, 2019·Updated Oct 16, 2025

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Carboplatin, and 5 other interventions for Carcinoma, Non-Small-Cell Lung. Active but no longer recruiting, targeting 461 participants across 108 sites in 22 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCarcinoma, Non-Small-Cell Lung

CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Spain, Taiwan, United Kingdom, United States

Collaborators--

Timeline

Phase 3Active

20202021202220232024202520262027

First PostedJul 2019

Enrollment StartNov 2019

Primary CompletionJul 2023

TodayJul 2026

Study CompletionJul 2027

First PostedJul 19, 2019

Enrollment StartNov 5, 2019

Primary CompletionJul 26, 2023

Study CompletionJul 30, 2027

TodayJul 2, 2026

Enrollment to primary: 3.7 yearsPosted 7.0 years ago