TAilored Post-Surgical Therapy in Early Stage NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

— TASTE  

Official title:

Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775385
• Other study ID #: IFCT-0801
• Secondary ID: Eudract : 2008-0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 17, 2008
• Last updated: March 1, 2017
• Start date: April 2009
• Est. completion date: January 21, 2016

Study information

• Verified date: March 2017
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 21, 2016
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted)

• Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008)

• Performance status (PS) = 0 or 1

• 18 years <= age < 70 years

• Signed inform consent

Exclusion Criteria:

• Squamous cell carcinoma

• Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix

• Inadequate renal or cardiac functions

• Pregnant women

• Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade = 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Standard Chemotherapy
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
• Customized Treatment
Mutated EGFR : Erlotinib 150mg/day (1 year) Wild-type EGFR or "undetermined" depends on ERCC1 status : ERCC1 high : no treatment ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

Locations

Country	Name	City	State
France	Centre Hospitalier	Aix en Provence
France	Clinique de L'Europe	Amiens
France	Angers - CHU	Angers
France	Centre Hospitalier	Béziers
France	Centre F. Baclesse	Caen
France	CHU - Pneumologie	Caen
France	Centre Hospitalier	Chauny
France	Chevilly Larue - CH	Chevilly Larue
France	Hôpital Percy-Armées - Pneumologie	Clamart
France	Clermont Ferrand - CHU	Clermont Ferrand
France	Colmar - CH	Colmar
France	Dax - CH	Dax
France	Ermont - Clinique Claude Bernard	Ermont
France	CHU Grenoble - pneumologie	Grenoble
France	Le Mans - CHG	Le Mans
France	Centre Léon Bérard	Lyon
France	Lyon - Hôpital Louis Pradel (Pneumologie)	Lyon
France	Mantes La Jolie - CH	Mantes La Jolie
France	APHM - Hôpital Sainte Marguerite	Marseille
France	Institut Paoli Calmette	Marseille
France	Metz - Belle Isle	Metz
France	Mont de Marsan - CH	Mont de Marsan
France	Montpellier - Clinique Clémentville	Montpellier
France	Mulhouse - CH	Mulhouse
France	Nancy - Polyclinique Gentilly	Nancy
France	Nevers - CH	Nevers
France	APHP - Hopital Tenon - Pneumologie	Paris
France	Paris - Saint Louis	Paris
France	Pau - CH	Pau
France	HCL - Lyon Sud (Pneumologie)	Pierre Bénite
France	Reims - CHU	Reims
France	Rennes - CHU	Rennes
France	Centre Hospitalier	Saint-Quentin
France	Nouvel Hopital Civil	Strasbourg
France	Hôpital Foch	Suresnes
France	Centre Hospitalier Intercommunal	Toulon
France	CHU Toulouse - Pneumologie	Toulouse
France	Clinique Pasteur	Toulouse
France	Tours - CHU	Tours
France	Nancy - CHU	Vandoeuvre lès Nancy
France	Institut Gustave Roussy	Villejuif
France	Centre Hospitalier Intercommunal	Villeneuve-Saint-Georges

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (1)

Wislez M, Barlesi F, Besse B, Mazières J, Merle P, Cadranel J, Audigier-Valette C, Moro-Sibilot D, Gautier-Felizot L, Goupil F, Renault A, Quoix E, Souquet PJ, Madroszyck A, Corre R, Pérol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)		week
Secondary	Disease-free Survival		month

External Links

•   IFCT official website