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

NCT02117167 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 999

Last updated 2024-01-10

No results posted yet for this study

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).

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

DRUG

AZD2014

Target: m-TOR

DRUG

AZD4547

Target: FGFR

DRUG

AZD5363

Target: AKT

DRUG

AZD8931

Target: HER2, EGFR

DRUG

Selumetinib

Target: MEK

DRUG

Vandetanib

Target : VEGF, EGFR

DRUG

Standard maintenance for squamous NSCLC

DRUG

Pemetrexed

Standard maintenance for non squamous NSCLC

DRUG

Durvalumab

Target: PD-L1

DRUG

savolitinib

target : MET

DRUG

Olaparib

target : PARP

Sponsors & Collaborators

  • Intergroupe Francophone de Cancerologie Thoracique

    collaborator OTHER

  • Fondation ARC

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Fabrice BARLESI, Pr · CHU Hopital Nord Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-23
Primary Completion
2018-12-22
Completion
2023-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117167 on ClinicalTrials.gov