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

Sponsor
UNICANCER
Study ID
NCT02117167
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2014 — DRUG
    Target: m-TOR
  • AZD4547 — DRUG
    Target: FGFR
  • AZD5363 — DRUG
    Target: AKT
  • AZD8931 — DRUG
    Target: HER2, EGFR
  • Selumetinib — DRUG
    Target: MEK
  • Vandetanib — DRUG
    Target : VEGF, EGFR
  • Standard maintenance for squamous NSCLC — DRUG
  • Pemetrexed — DRUG
    Standard maintenance for non squamous NSCLC
  • Durvalumab — DRUG
    Target: PD-L1
  • savolitinib — DRUG
    target : MET
  • Olaparib — DRUG
    target : PARP

Study Details

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).

Key Dates

Start date
Apr 23, 2014
Status verified
Jan 2024
Primary completion
Dec 22, 2018
Completion
Dec 31, 2023

Study Design

Enrollment
999 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: targeted agent
    Arm A1/ targeted arm: targeted maintenance from a list of targeted drugs guided by the genomic analysis, AZD2014 tablet per os 50 mg bd, continuous dosing, AZD4547 tablet per os 80 mg bd, 2 weeks on/1 week off, AZD5363 capsule per os 480 mg bd, 4 days on/3 days off, AZD8931 tablet per os 40 mg bd, continuous dosing, selumetinib capsule per os 75 mg bd, continuous dosing, vandetanib tablet per os 300 mg od, continuous dosing, olaparib tablet per os 300 mg bd continuous dosing savolitinib tablet per os 600 mg od continuous dosing
  • Active Comparator: Substudy 1: standard maintenance therapy
    Arm B1/ standard arm pemetrexed Intra venous 500 mg/m², every 3 weeks, standard maintenance left to the investigator's choice
  • Experimental: Substudy 2: Immunotherapy
    Arm A2/ Immunotherapy arm: maintenance with durvalumab for patient without actionable genomic alterations or non eligible to Targeted substudy 1, durvalumab Intra-venous 10 mg/kg, Q2W
  • Active Comparator: Substudy 2: standard maintenance therapy
    Arm B2/ standard arm pemetrexed Intra venous 500 mg/m², every 3 weeks, standard maintenance left to the investigator's choice

Primary Outcome Measure

progression-free survival in the targeted drug arm compared to standard maintenance therapy arm [ Time Frame: from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months) ]

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