Clinical Trial: NCT02477826 - My Cancer Genome

NCT02477826

Description:

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02477826

Trial Eligibility

Document

Title

Brief Title: An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Official Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

ORG STUDY ID: CA209-227
SECONDARY ID: 2014-003630-23
NCT ID: NCT02477826

Conditions

Non-Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	Opdivo	Arm A: Nivolumab
Ipilimumab	Yervoy	Arm B: Nivolumab + Ipilimumab
Carboplatin		Arm C: Nivolumab + Platinum doublet chemotherapy
Cisplatin		Arm C: Nivolumab + Platinum doublet chemotherapy
Gemcitabine		Arm C: Nivolumab + Platinum doublet chemotherapy
Pemetrexed		Arm C: Nivolumab + Platinum doublet chemotherapy
Paclitaxel		Arm C: Nivolumab + Platinum doublet chemotherapy

Purpose

Trial Arms

Name	Type	Description	Interventions
Arm A: Nivolumab	Experimental	Nivolumab intravenously (IV) as specified	Nivolumab
Arm B: Nivolumab + Ipilimumab	Experimental	Nivolumab + Ipilimumab IV as specified	Nivolumab Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapy	Experimental	Nivolumab + Platinum doublet chemotherapy (IV) dose as specified	Nivolumab Carboplatin Cisplatin Gemcitabine Pemetrexed Paclitaxel
Arm D: Platinum doublet chemotherapy	Experimental	Chemotherapy administered on specified days of IV chemotherapy	Carboplatin Cisplatin Gemcitabine Pemetrexed Paclitaxel

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or
             non-squamous histology, with no prior systemic anticancer therapy

          -  Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC)
             testing, with results, performed by the central lab during the Screening period

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

          -  Measurable disease by CT or MRI per response evaluation criteria in solid tumors
             version 1.1 (RECIST 1.1) criteria

        Exclusion Criteria:

          -  Subjects with untreated Central nervous system (CNS) metastases are excluded

          -  Subjects with an active, known or suspected autoimmune disease are excluded

          -  Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency
             virus (HIV) indicating acute or chronic infection

        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:	Overall survival (OS)
Time Frame:	approximately 48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Objective response rate (ORR)
Time Frame:	Up to 48 months
Safety Issue:
Description:	ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer

Measure:	Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
Time Frame:	Up to 48 months
Safety Issue:
Description:	Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

March 23, 2021

Clinical Trials /

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)