SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients
SAFIR02_Lung
Intergroup Trial UNICANCER UC 0105-1305/ IFCT 1301: SAFIR02_Lung - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Non-small Cell Lung Cancer
2 other identifiers
interventional
999
1 country
37
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
Longer than P75 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedStudy Start
First participant enrolled
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 10, 2024
January 1, 2024
4.7 years
April 8, 2014
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
progression-free survival in the targeted drug arm compared to standard maintenance therapy arm
To evaluate whether treatment with targeted agents guided by high throughput molecular analysis (CGH array, next generation sequencing) improves progression-free survival as compared to standard maintenance therapy in patients with metastatic NSCLC
from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
Secondary Outcomes (6)
progression-free survival in patients treated with anti-PDL1 antibody (MEDI4736) compared to standard maintenance therapy arm
from randomization to disease progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
overall survival in each substudy
from randomization to death (any cause), up to 16 months
overall response rates and changes in tumor size in each substudy
tumor response is assessed every 21 days from treatment initiation until first progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
evaluate safety, in each substudy
toxicities will be assessed during the whole treatment period (4 months expected in average) followed by a 1-year post-treatment follow-up period, and reported during the visits scheduled by the study flow chart
efficacy (response rate, change in tumor size, progression-free survival, overall survival) and safety of each individual targeted agent (substudy 1)
tumor response is assessed every 21 days from treatment initiation until first progression or death from any cause, whichever comes first, up to 16 months (estimated treatment duration average: 4 months)
- +1 more secondary outcomes
Study Arms (4)
Substudy 1: targeted agent
EXPERIMENTALArm 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
Substudy 1: standard maintenance therapy
ACTIVE COMPARATORArm B1/ standard arm pemetrexed Intra venous 500 mg/m², every 3 weeks, standard maintenance left to the investigator's choice
Substudy 2: Immunotherapy
EXPERIMENTALArm 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
Substudy 2: standard maintenance therapy
ACTIVE COMPARATORArm B2/ standard arm pemetrexed Intra venous 500 mg/m², every 3 weeks, standard maintenance left to the investigator's choice
Interventions
Standard maintenance for non squamous NSCLC
Eligibility Criteria
You may qualify if:
- histologically proven NSCLC
- Metastatic relapse or stage IV at diagnosis, or stage IIIb not amenable to surgery or radiotherapy
- No EGFR-activating mutation or ALK translocation
- primary tumor or metastases that can be biopsied, excluding bone.
- Age \>18 years
- WHO Performance Status 0/1
- Chemo-naïve patients eligible to a first line platinum-based chemotherapy
- No tumor progression observed with the current line of treatment
- measurable target lesion or evaluable diseases RECIST
You may not qualify if:
- Spinal cord compression and/or symptomatic or progressive brain metastases
- Abnormal coagulation contraindicating biopsy
- Inability to swallow
- Major problem with intestinal absorption
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
- Any factors increasing the risk of QTc prolongation or arrhythmic events
- Experience of any of the following in the preceding 12 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, past or current uncontrolled angina pectoris, congestive heart failure NYHA Grade ≥2, torsades de pointes, current uncontrolled hypertension, cardiomyopathy
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which requires steroid treatment or any evidence of clinically interstitial lung disease
- Previous or current malignancies of other histologies within the last 5 years,
- Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
- Diagnosis of diabetes mellitus type I or II
- diagnosis of acne rosacea, severe psoriasis and severe atopic eczema
- Prior exposure to anthracyclines or mitoxantrone with cumulative exposure in excess of 360 mg/m² for doxorubicin, 720 mg/m² for epirubicin, or 72 mg/m² for mitoxantrone
- History of retinal degenerative disease, eye injury or corneal surgery in the previous 3 months, past history of central serous retinopathy or retinal vein occlusion, intraocular pressure \>21 mmHg, or uncontrolled glaucoma.
- History of hemorrhagic or thrombotic stroke, TIA or other CNS bleeds
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- Intergroupe Francophone de Cancerologie Thoraciquecollaborator
- Fondation ARCcollaborator
- AstraZenecacollaborator
Study Sites (37)
Centre Hospitalier Henri Duffau
Avignon, France
Centre Hospitalier Universitaire de Besancon - Hopital Jean Minjoz
Besançon, France
Hôpital Avicenne
Bobigny, France
Institut Bergonié
Bordeaux, France
Hôpital Ambroise Paré
Boulogne-Billancourt, France
Hospices Civils de Lyon- Hôpital Louis Pradel
Bron, France
Centre François Baclesse
Caen, France
CHU Caen
Caen, France
Chu de Caen - Hopital Cote de Nacre
Caen, France
Hôpital Louis Pasteur
Chartres, France
centre Jean Perrin
Clermont-Ferrand, France
CHU Clermont Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hopitaux Civils de Colmar
Colmar, France
Centre Hopsitalier Intercommunal de Créteil
Créteil, France
Centre Georges François Leclerc
Dijon, France
CHU Grenoble
Grenoble, France
Chd Vendee
La Roche-sur-Yon, France
CH du Mans
Le Mans, France
Centre Oscar Lambret
Lille, France
CHRU de Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital Nord
Marseille, France
Institut Paoli Calmettes
Marseille, France
Institut de cancérologie de l'Ouest
Nantes, France
Centre Antoine Lacassagne
Nice, France
Chr Orleans
Orléans, France
AH-HP Hôpital Saint Louis
Paris, France
AP-HP Hôpital Cochin
Paris, France
AP-HP Hôpital Tenon
Paris, France
Institut Curie
Paris, France
Centre Hospitalier de Pau
Pau, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Chru Strasbourg - Nouvel Hopital Civil
Strasbourg, France
CHI de Toulon - Hôpital Sainte-Musse
Toulon, France
CHU Toulouse -Hôpital Larrey
Toulouse, France
Hôpital Bretonneau
Tours, France
Gustave Roussy
Villejuif, France
Related Publications (1)
Middleton G, Crack LR, Popat S, Swanton C, Hollingsworth SJ, Buller R, Walker I, Carr TH, Wherton D, Billingham LJ. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9. doi: 10.1093/annonc/mdv394. Epub 2015 Sep 25.
PMID: 26410619DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice BARLESI, Pr
CHU Hopital Nord Marseille
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 17, 2014
Study Start
April 23, 2014
Primary Completion
December 22, 2018
Study Completion
December 1, 2023
Last Updated
January 10, 2024
Record last verified: 2024-01