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drugset / Trial / NCT02117167

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

NCT02117167 ↗

Phase 2 Completed 999 enrolled UNICANCER AstraZeneca · collabFondation ARC · collabIntergroupe Francophone de Cancerologie Thoracique · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

Timeline

Start
2014-04-23
Primary completion
2018-12-22
Completion
2023-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Capivasertib Small molecule 480 mg Oral
Subject Durvalumab Monoclonal antibody 10 mg/kg Intravenous
Subject Fexagratinib Small molecule 80 mg Oral
Subject Olaparib Small molecule 300 mg Oral
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject SAPITINIB Small molecule 40 mg Oral
Subject Savolitinib Small molecule 600 mg Oral
Subject Selumetinib Small molecule 75 mg Oral
Subject Vandetanib Small molecule 300 mg Oral
Subject Vistusertib Small molecule 50 mg Oral

Indications

non-small cell lung carcinoma