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)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02041533 |
|
Recruitment Status :
Completed
First Posted : January 22, 2014
Results First Posted : July 26, 2017
Last Update Posted : March 2, 2023
|
Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage IV or Recurrent Non-Small Cell Lung Cancer | Biological: Nivolumab Drug: Gemcitabine Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 541 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 27, 2014 |
| Actual Primary Completion Date : | July 1, 2016 |
| Actual Study Completion Date : | May 27, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information
available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm A: Nivolumab subjects
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
|
Biological: Nivolumab
Other Names:
|
|
Active Comparator: Arm B: Investigator's Choice Chemotherapy
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:
Non-Squamous subjects:
Optional crossover:
|
Biological: Nivolumab
Other Names:
Drug: Gemcitabine Other Name: Gemzar Drug: Cisplatin Other Name: Platinol Drug: Carboplatin Other Name: Paraplatin Drug: Paclitaxel Other Name: Taxol Drug: Pemetrexed Other Name: Alimta |
Primary Outcome Measures :
- 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) ]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 :
- 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) ]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.
- Overall Survival in Participants With PD-L1 Expression >= 5% [ Time Frame: From date of randomization to date of death (up to approximately 89 months) ]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.
- Overall Survival in All Randomized Participants [ Time Frame: From date of randomization to date of death (up to approximately 89 months) ]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.
- 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) ]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.
- Disease-related Symptom Improvement Rate by Week 12 [ Time Frame: From date of randomization to week 12 ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041533
Locations
Show 141 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02041533 |
| Other Study ID Numbers: |
CA209-026 2012-004502-93 ( EudraCT Number ) |
| First Posted: | January 22, 2014 Key Record Dates |
| Results First Posted: | July 26, 2017 |
| Last Update Posted: | March 2, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Recurrence Disease Attributes Pathologic Processes Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Carboplatin |
Gemcitabine Nivolumab Pemetrexed Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Enzyme Inhibitors Folic Acid Antagonists |