TAilored Post-Surgical Therapy in Early Stage NSCLC

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).

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775385

Acronym

TASTE

Enrollment

152

Registered

2008-10-20

Start date

2009-04-30

Completion date

2016-01-21

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Chemotherapy, Adjuvant

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.

Interventions

DRUGStandard Chemotherapy

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

DRUGCustomized 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)	week

Secondary

Measure	Time frame
Disease-free Survival	month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026