NCT04025879|Active Not RecruitingPhase 3ResultsDMCFDA Drug

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

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 ClinicalTrials.gov

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2 other identifiers

CA209-77T2019-000262-38

Study Type

interventional

Target

461

Locations

22 countries

Sites

108

Timeline

RegisteredJul 2019

StartedNov 2019

CompletionJul 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

461

participants targeted

Target at P50-P75 for phase_3

Timeline

14mo left

Started Nov 2019

Longer than P75 for phase_3

Geographic Reach

22 countries

108 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Progress85%

Nov 2019Jul 2027

First Submitted

Initial submission to the registry

July 17, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed

4 months until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed

12 months until next milestone

Results Posted

Study results publicly available

July 23, 2024

Completed

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Expected

Last Updated

October 16, 2025

Status Verified

January 1, 2025

Enrollment Period

3.7 years

First QC Date

July 17, 2019

Results QC Date

June 26, 2024

Last Update Submit

October 7, 2025

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

Event-Free Survival (EFS) by BICR
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)

Secondary Outcomes (6)

Overall Survival (OS)
From randomization and the date of death due to any cause.
Pathologic Complete Response (pCR) Rate
From randomization up to approximately 44 months
Major Pathological Response (MPR) Rate
From randomization up to approximately 44 months
The Number of Participants With Adverse Events (AEs)
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
The Number of Participants With Serious Adverse Events (SAEs)
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
+1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

Biological: NivolumabDrug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: PemetrexedDrug: Docetaxel

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

PLACEBO COMPARATOR

Drug: CarboplatinDrug: CisplatinDrug: PaclitaxelDrug: PemetrexedDrug: PlaceboDrug: Docetaxel