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AzTrials

Carcinoma, Non-Small-Cell LungPhase 2/3TASTENCT00775385

TAilored Post-Surgical Therapy in Early Stage NSCLC

A Phase 2/3 study testing Standard Chemotherapy and Customized Treatment in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 42 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Standard Chemotherapy and Customized Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
42 sitesFrance
Study dates
Apr 2009to 21 Jan 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

France42 sites

  • Centre Hospitalier

    Aix-en-Provence

  • Clinique de L'Europe

    Amiens

  • Angers - CHU

    Angers, 49000

  • Centre Hospitalier

    Béziers

  • Centre F. Baclesse

    Caen, 14000

  • CHU - Pneumologie

    Caen, 14000

  • Centre Hospitalier

    Chauny

  • Chevilly Larue - CH

    Chevilly-Larue

  • Hôpital Percy-Armées - Pneumologie

    Clamart, 92140

  • Clermont Ferrand - CHU

    Clermont-Ferrand, 63000

  • Colmar - CH

    Colmar, 68000

  • Dax - CH

    Dax, 40107

  • Ermont - Clinique Claude Bernard

    Ermont

  • CHU Grenoble - pneumologie

    Grenoble, 38000

  • Le Mans - CHG

    Le Mans

  • Centre Léon Bérard

    Lyon, 69000

  • Lyon - Hôpital Louis Pradel (Pneumologie)

    Lyon

  • Mantes La Jolie - CH

    Mantes-la-Jolie, 78200

  • APHM - Hôpital Sainte Marguerite

    Marseille, 13000

  • Institut Paoli Calmette

    Marseille

  • Metz - Belle Isle

    Metz

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Montpellier - Clinique Clémentville

    Montpellier, 34070

  • Mulhouse - CH

    Mulhouse, 68000

  • Nancy - Polyclinique Gentilly

    Nancy

  • Nevers - CH

    Nevers, 58033

  • Paris - Saint Louis

    Paris, 75000

  • APHP - Hopital Tenon - Pneumologie

    Paris, 75020

  • Pau - CH

    Pau, 64046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • Reims - CHU

    Reims, 51092

  • Rennes - CHU

    Rennes

  • Centre Hospitalier

    Saint-Quentin

  • Nouvel Hopital Civil

    Strasbourg, 63000

  • Hôpital Foch

    Suresnes

  • Centre Hospitalier Intercommunal

    Toulon

  • CHU Toulouse - Pneumologie

    Toulouse

  • Clinique Pasteur

    Toulouse

  • Tours - CHU

    Tours, 37000

  • Nancy - CHU

    Vandœuvre-lès-Nancy, 54500

  • Institut Gustave Roussy

    Villejuif, 94805

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges

Other trials in France

About this study

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).

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.

Being tested
Standard Chemotherapy, Customized Treatment
Keywords
Chemotherapy, Adjuvant
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard ChemotherapyDrug

    Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles

  • Customized TreatmentDrug

    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)
Study groups in NCT00775385
Study groupRoleWhat they receive
AActive comparatorStandard chemotherapy
Receives: Drug: Standard Chemotherapy
BExperimentalCustomized treatment
Receives: Drug: Customized Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)

    Measured: week

Secondary outcomes (1)

  1. Disease-free Survival

    Measured: month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2008 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2013
  4. Study completion21 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775385
Sponsor's protocol ID
IFCT-0801
Other IDs
Eudract : 2008-004939-38
Acronym
TASTE
Status last verified
Mar 2017
First submitted
17 Oct 2008
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24638013

  • Oudart 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.

    PubMed 38428265

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standard Chemotherapy and Customized Treatment in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 42 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) (time frame: week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00775385, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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