A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.

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 (CheckMate 77T, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 77T)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000262-38-DE

Enrollment

750

Registered

2019-08-09

Start date

2019-10-17

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Stage II-IIIB Non-small cell lung cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: OPDIVO 10 mg/mL concentrate for solution for infusion. Product Name: NIVOLUMAB - 10ml vial - COMMERCIAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 Other protocol defined inclusion criteria apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 375

Exclusion criteria

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 Tcell co stimulation or checkpoint pathways Other protocol defined exclusion criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A vs Arm B participants;Secondary Objective: - To compare the overall survival (OS) in Arm A vs Arm B participants - To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants - To assess the major pathological response (MPR) rate by BIPR in Arm A vs Arm B participants - To assess safety and tolerability in Arm A vs Arm B participants;Primary end point(s): Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR);Timepoint(s) of evaluation of this end point: 5 Years from randomization	—

Measure

Time frame

Main Objective: To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A vs Arm B participants;Secondary Objective: - To compare the overall survival (OS) in Arm A vs Arm B participants - To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants - To assess the major pathological response (MPR) rate by BIPR in Arm A vs Arm B participants - To assess safety and tolerability in Arm A vs Arm B participants;Primary end point(s): Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR);Timepoint(s) of evaluation of this end point: 5 Years from randomization

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall Survival (OS) 2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) 3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review 4. Incidence of Serious Adverse Events (SAEs) 5. Incidence of Adverse Events (AEs);Timepoint(s) of evaluation of this end point: 1. Up to 5 years from randomization 2. At the time of surgery, between week 12 to week 18 3. Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 4. Up to 80 weeks 5. Up to 80 weeks	—

Measure

Time frame

Secondary end point(s): 1. Overall Survival (OS) 2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) 3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review 4. Incidence of Serious Adverse Events (SAEs) 5. Incidence of Adverse Events (AEs);Timepoint(s) of evaluation of this end point: 1. Up to 5 years from randomization 2. At the time of surgery, between week 12 to week 18 3. Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 4. Up to 80 weeks 5. Up to 80 weeks

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Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026