A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Biological: Nivolumab; Drug: Cisplatin; Drug: Vinorelbine; Biological: Ipilimumab; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT02998528
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Study Start: 2017-03-04
• Primary Completion: 2021-09-08
• Results First Submitted: 2022-08-31
• Results First Submitted QC: 2022-08-31
• Results First Posted: 2022-09-28
• Study Completion: 2024-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
• Lung function capacity capable of tolerating the proposed lung surgery
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Available tissue of primary lung tumor

Exclusion Criteria

• Presence of locally advanced, inoperable or metastatic disease
• Participants with active, known or suspected autoimmune disease
• Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab plus Ipilimumab	Nivolumab	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Cisplatin	Specified dose on specified days
Platinum doublet chemotherapy	Pemetrexed	Specified dose on specified days
Platinum doublet chemotherapy	Docetaxel	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Gemcitabine	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Carboplatin	Specified dose on specified days
Platinum doublet chemotherapy	Vinorelbine	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Nivolumab	Specified dose on specified days
Nivolumab plus Ipilimumab	Ipilimumab	Specified dose on specified days
Platinum doublet chemotherapy	Paclitaxel	Specified dose on specified days
Platinum doublet chemotherapy	Cisplatin	Specified dose on specified days
Platinum doublet chemotherapy	Gemcitabine	Specified dose on specified days
Platinum doublet chemotherapy	Carboplatin	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Paclitaxel	Specified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Pemetrexed	Specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Event-Free Survival (EFS)	From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)	Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Pathologic Complete Response (pCR) Rate	From randomization up to a median of 30 months after randomization.	Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).

Secondary Outcome Measures

Name	Time	Method
Major Pathologic Response (MPR) Rate	From randomization up to a median of 30 months after randomization.	Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Overall Survival (OS)	From randomization to the date of death	Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
Time to Death or Distant Metastases (TTDM)	From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)	TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.

Trial Locations

Locations (137)

Local Institution - 0121; 🇺🇸 Glendale, Arizona, United States

Local Institution - 0081; 🇺🇸 Los Angeles, California, United States

Local Institution - 0025; 🇺🇸 Denver, Colorado, United States

Local Institution - 0007; 🇺🇸 Plainville, Connecticut, United States

Local Institution - 0173; 🇺🇸 Hollywood, Florida, United States

Local Institution - 0136; 🇺🇸 Miami, Florida, United States

Local Institution - 0054; 🇺🇸 Orlando, Florida, United States

Orlando Health, Inc.; 🇺🇸 Orlando, Florida, United States

Indian River Medical Center; 🇺🇸 Vero Beach, Florida, United States

Northwest Georgia Oncology Center, P.C.; 🇺🇸 Marietta, Georgia, United States

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