Clinical Trial: NCT02998528 - My Cancer Genome

NCT02998528

Description:

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02998528

Trial Eligibility

Document

Title

Brief Title: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Official Title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Clinical Trial IDs

ORG STUDY ID: CA209-816
SECONDARY ID: 2016-003536-21
NCT ID: NCT02998528

Conditions

Non Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	BMS-936558, Opdivo	Nivolumab plus Ipilimumab
Cisplatin		Nivolumab plus platinum doublet chemotherapy
Vinorelbine		Platinum doublet chemotherapy
Gemcitabine		Nivolumab plus platinum doublet chemotherapy
Docetaxel		Platinum doublet chemotherapy
Pemetrexed		Nivolumab plus platinum doublet chemotherapy
Carboplatin		Nivolumab plus platinum doublet chemotherapy
Paclitaxel		Nivolumab plus platinum doublet chemotherapy
Ipilimumab	BMS-734016, Yervoy	Nivolumab plus Ipilimumab

Purpose

Trial Arms

Name	Type	Description	Interventions
Platinum doublet chemotherapy	Active Comparator	Specified dose on specified days	Cisplatin Vinorelbine Gemcitabine Docetaxel Pemetrexed Carboplatin Paclitaxel
Nivolumab plus platinum doublet chemotherapy	Experimental	Specified dose on specified days	Nivolumab Cisplatin Gemcitabine Pemetrexed Carboplatin Paclitaxel
Nivolumab plus Ipilimumab	Experimental	Specified dose on specified days	Nivolumab Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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 could apply

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Event-Free Survival (EFS)
Time Frame:	Up to 69 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Overall survival (OS)
Time Frame:	Up to approximately 193 months
Safety Issue:
Description:

Measure:	Major pathological response (MPR)
Time Frame:	At time of surgery
Safety Issue:
Description:

Measure:	Time to Death or Distant Metastases (TTDM)
Time Frame:	Up to 69 months
Safety Issue:
Description:

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

August 26, 2020

Clinical Trials /

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