Clinical Trial: NCT02041533 - My Cancer Genome

NCT02041533

Description:

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02041533

Trial Eligibility

Document

Title

Brief Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Official Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

Clinical Trial IDs

ORG STUDY ID: CA209-026
SECONDARY ID: 2012-004502-93
NCT ID: NCT02041533

Conditions

Stage IV or Recurrent Non-Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	BMS-936558, MDX-1106	Arm A: Nivolumab subjects
Gemcitabine	Gemzar	Arm B: Investigator's Choice Chemotherapy
Cisplatin	Platinol	Arm B: Investigator's Choice Chemotherapy
Carboplatin	Paraplatin	Arm B: Investigator's Choice Chemotherapy
Paclitaxel	Taxol	Arm B: Investigator's Choice Chemotherapy
Pemetrexed	Alimta	Arm B: Investigator's Choice Chemotherapy

Purpose

Trial Arms

Name	Type	Description	Interventions
Arm A: Nivolumab subjects	Experimental	Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure	Nivolumab
Arm B: Investigator's Choice Chemotherapy	Active Comparator	Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure	Nivolumab Gemcitabine Cisplatin Carboplatin Paclitaxel Pemetrexed

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1

          -  Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic
             anticancer therapy

          -  Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per
             response evaluation criteria in solid tumors version (RECIST) 1.1 criteria

          -  PD-L1+ on immunohistochemistry testing performed by central lab

          -  Men and women, ages ≥ 18 years of age

        Exclusion Criteria:

          -  Known epidermal growth factor receptor (EGFR) mutations which are sensitive to
             available targeted inhibitor therapy

          -  Known anaplastic lymphoma kinase (ALK) translocations

          -  Untreated central nervous system (CNS) metastases

          -  Previous malignancies

          -  Active, known or suspected autoimmune disease

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

Primary Outcome Measures

Measure:	Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Time Frame:	From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

Secondary Outcome Measures

Measure:	Progression-Free Survival in All Randomized Participants
Time Frame:	From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

Measure:	Overall Survival in Participants With PD-L1 Expression >= 5%
Time Frame:	From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.

Measure:	Overall Survival in All Randomized Participants
Time Frame:	From date of randomization to date of death (assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.

Measure:	Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
Time Frame:	From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

Measure:	Duration of Response in Participants With PD-L1 Expression>= 5%
Time Frame:	From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)
Safety Issue:
Description:	Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir

Measure:	Time to Response in Participants With PD-L1 Expression >= 5%
Time Frame:	From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)
Safety Issue:
Description:	Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

Measure:	Disease-related Symptom Improvement Rate by Week 12
Time Frame:	From date of randomization to week 12
Safety Issue:
Description:	The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.

Details

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

Last Updated

June 14, 2021

Clinical Trials /

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)