Phase 2 Completed NCT02117167

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

UNICANCER · Interventional, Randomized

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Completed December 2023. Read the results summary below →
Lung Cancer

Study context: no flags matched. Amendment history is not available for this trial's data source.

Overview

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).

Full record on ClinicalTrials.gov (NCT ID NCT02117167).

Results summary

None

Outcome data

EndpointTypeResultSignificance
progression-free survival in the targeted drug arm compared to standard maintenance therapy arm Primary None None
progression-free survival in patients treated with anti-PDL1 antibody (MEDI4736) compared to standard maintenance therapy arm Secondary None None
overall survival in each substudy Secondary None None
overall response rates and changes in tumor size in each substudy Secondary None None
evaluate safety, in each substudy Secondary None None
efficacy (response rate, change in tumor size, progression-free survival, overall survival) and safety of each individual targeted agent (substudy 1) Secondary None None
correlate molecular characteristics in patients with the efficacy endpoints (response rate, progression-free and overall survival) in each substudy Secondary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Masking
Open label
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment (final)
999 participants
Started
April 2014
Actually completed
December 2023

Recruitment criteria

Age range: ≥ 18 · Sex: All · Healthy volunteers: Requires diagnosis

Locations

37 sites participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

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)

Sources

REG
ClinicalTrials.gov — NCT02117167
Trial registry · primary record
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