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Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC (ECTOP-1001)

NCT01833572 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-12

No results posted yet for this study

Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1001. This is an open-label, single-arm, phase II interventional clinical trial. The investigators hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating (19/21) mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all the participants' biopsy samples and confirmed in surgical resected samples. Eligible patients will be given gefitinib 250mg for 42days followed with surgical resection of tumor. Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR), pathologic (pathologic response), surgical (complete resection) evaluations, and safety is based on adverse effect evaluations.

Conditions

  • Non-small-cell Lung Cancer

Interventions

DRUG

Gefitinib

Eligible participants will be given orally gefitinib 250mg daily before surgery for 42 days or until disease progression or unacceptable toxicity. Best supportive care is allowed in this period.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Haiquan Chen, MD · Fudan Univerisity Shanghai Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01833572 on ClinicalTrials.gov