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)
CompletedPhase 3Results postedLast updated 2 March 2023
What this trial tests
Phase 3 trial testing Nivolumab in Stage IV or Recurrent Non-Small Cell Lung Cancer in 541 participants. Completed in 27 May 2022.
18 and older, any sex, with Stage IV or Recurrent Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival in Participants With PD-L1 Expression >= 5%Primary· 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 ass
Group
Value
95% CI
Nivolumab
4.21
2.96 – 5.55
Investigator Choice of Chemotherapy
5.88
5.42 – 6.93
Progression-Free Survival in All Randomized ParticipantsSecondary· 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 ass
Group
Value
95% CI
Nivolumab
4.21
3.06 – 5.52
Investigator Choice of Chemotherapy
5.82
5.42 – 6.90
Overall Survival in Participants With PD-L1 Expression >= 5%Secondary· 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.
Group
Value
95% CI
Nivolumab
14.36
11.66 – 17.08
Investigator Choice of Chemotherapy
13.21
10.81 – 17.28
Overall Survival in All Randomized ParticipantsSecondary· 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.
Group
Value
95% CI
Nivolumab
13.73
11.76 – 15.41
Investigator Choice of Chemotherapy
13.80
11.01 – 16.99
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%Secondary· 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 treat
Group
Value
95% CI
Nivolumab
26.1
20.3 – 32.5
Investigator Choice of Chemotherapy
33.5
27.2 – 40.3
Disease-related Symptom Improvement Rate by Week 12Secondary· 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
Group
Value
95% CI
Nivolumab
35.4
29.7 – 41.4
Investigator Choice of Chemotherapy
33.7
28.1 – 39.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (up to approximately 89 months). SAEs and Other AEs were assessed from their first dose to 100 days following their last dose (up to approximately 89 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab
Serious: 195/267 (73%)
Deaths: 233/271
Investigator Choice of Chemotherapy
Serious: 203/263 (77%)
Deaths: 92/270
Post Chemotherapy Optional Nivolumab
Serious: 110/159 (69%)
Deaths: 136/159
Serious adverse events (265 terms)
Reaction
System
Nivolumab
Investigator Choice of Che…
Post Chemotherapy Optional…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Pneumonia
Infections and infestations
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Anaemia
Blood and lymphatic system disorders
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Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
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Pyrexia
General disorders
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Dyspnoea
Respiratory, thoracic and mediastinal disorders
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Pneumonitis
Respiratory, thoracic and mediastinal disorders
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—
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Fatigue
General disorders
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Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
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NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
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NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 2 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02041533.