TAilored Post-Surgical Therapy in Early Stage NSCLC
TASTE
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).
2 other identifiers
interventional
152
1 country
42
Brief 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.
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 2009
Longer than P75 for phase_2
42 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
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2016
CompletedMarch 3, 2017
March 1, 2017
4 years
October 17, 2008
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)
week
Secondary Outcomes (1)
Disease-free Survival
month
Study Arms (2)
A
ACTIVE COMPARATORStandard chemotherapy
B
EXPERIMENTALCustomized treatment
Interventions
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
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)
Eligibility Criteria
You may qualify if:
- 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
- years \<= age \< 70 years
- Signed inform consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Centre Hospitalier
Aix-en-Provence, France
Clinique de L'Europe
Amiens, France
Angers - CHU
Angers, 49000, France
Centre Hospitalier
Béziers, France
Centre F. Baclesse
Caen, 14000, France
CHU - Pneumologie
Caen, 14000, France
Centre Hospitalier
Chauny, France
Chevilly Larue - CH
Chevilly-Larue, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, France
Clermont Ferrand - CHU
Clermont-Ferrand, 63000, France
Colmar - CH
Colmar, 68000, France
Dax - CH
Dax, 40107, France
Ermont - Clinique Claude Bernard
Ermont, France
CHU Grenoble - pneumologie
Grenoble, 38000, France
Le Mans - CHG
Le Mans, France
Centre Léon Bérard
Lyon, 69000, France
Lyon - Hôpital Louis Pradel (Pneumologie)
Lyon, France
Mantes La Jolie - CH
Mantes-la-Jolie, 78200, France
APHM - Hôpital Sainte Marguerite
Marseille, 13000, France
Institut Paoli Calmette
Marseille, France
Metz - Belle Isle
Metz, France
Mont de Marsan - CH
Mont-de-Marsan, 40000, France
Montpellier - Clinique Clémentville
Montpellier, 34070, France
Mulhouse - CH
Mulhouse, 68000, France
Nancy - Polyclinique Gentilly
Nancy, France
Nevers - CH
Nevers, 58033, France
Paris - Saint Louis
Paris, 75000, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
Pau - CH
Pau, 64046, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
Reims - CHU
Reims, 51092, France
Rennes - CHU
Rennes, France
Centre Hospitalier
Saint-Quentin, France
Nouvel Hopital Civil
Strasbourg, 63000, France
Hôpital Foch
Suresnes, France
Centre Hospitalier Intercommunal
Toulon, France
CHU Toulouse - Pneumologie
Toulouse, France
Clinique Pasteur
Toulouse, France
Tours - CHU
Tours, 37000, France
Nancy - CHU
Vandœuvre-lès-Nancy, 54500, France
Institut Gustave Roussy
Villejuif, 94805, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, France
Related Publications (2)
Wislez M, Barlesi F, Besse B, Mazieres 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, Perol D, Morin F, Zalcman G, Soria JC. Customized adjuvant phase II trial in patients with non-small-cell lung cancer: IFCT-0801 TASTE. J Clin Oncol. 2014 Apr 20;32(12):1256-61. doi: 10.1200/JCO.2013.53.1525. Epub 2014 Mar 17.
PMID: 24638013RESULTOudart JB, Garinet S, Leger C, Barlesi F, Mazieres J, Jeannin G, Audigier-Valette C, Morot-Sibilot D, Langlais A, Amour E, Mathiot N, Birsen G, Blons H, Wislez M. STK11/LKB1 alterations worsen the poor prognosis of KRAS mutated early-stage non-squamous non-small cell lung carcinoma, results based on the phase 2 IFCT TASTE trial. Lung Cancer. 2024 Apr;190:107508. doi: 10.1016/j.lungcan.2024.107508. Epub 2024 Feb 19.
PMID: 38428265DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Charles SORIA, Pr
Institut Gustave Roussy (IGR)
- PRINCIPAL INVESTIGATOR
Marie Wislez, Pr
APHP - Hôpital Tenon (Paris)
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
October 17, 2008
First Posted
October 20, 2008
Study Start
April 1, 2009
Primary Completion
April 1, 2013
Study Completion
January 21, 2016
Last Updated
March 3, 2017
Record last verified: 2017-03