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)

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

Timeline

Start

2014-03-27

Primary completion

2016-07-01

Completion

2022-05-27

Outcome

Missed primary endpoint

registry analysis (unspecified test); Nivolumab vs Investigator Choice of Chemotherapy; p = 0.2511; Hazard Ratio (HR) 1.15 (95% CI 0.91 to 1.45); Log Rank NCT02041533 ↗

paper Nivolumab was not associated with significantly longer progression-free survival than chemotherapy PMID 28636851 ↗

Publications

• Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.
• Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	5 unknown	Intravenous
Comparator	Carboplatin	Small molecule	6 unknown	Intravenous
Comparator	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Comparator	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Comparator	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications