Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

Phase 1/2 Terminated 43 enrolled Pfizer

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

Timeline

Start: 2015-12-18
Primary completion: 2021-02-02
Completion: 2022-07-13

Outcome

Outcome not reported

Stopped: “The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)”

Publications

Solomon BJ, Dagogo-Jack I, Lee SH, Boyer MJ, Ramalingam SS, Carcereny E, Felip E, Han JY, Hida T, Hughes BGM, Kim SW, Nishio M, Seto T, Okamoto T, Zhang X, Martini JF, Wang E, De Beukelaer S, Bauer TM. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial. JTO Clin Res Rep. 2024 May 16;5(7):100685. doi: 10.1016/j.jtocrr.2024.100685. eCollection 2024 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Crizotinib	Small molecule	200 mg	Oral
Subject	Crizotinib	Small molecule	250 mg	Oral
Subject	Lorlatinib	Small molecule	50 mg	Oral
Subject	Lorlatinib	Small molecule	75 mg	Oral
Subject	Lorlatinib	Small molecule	100 mg	Oral