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

July 11, 2023 updated by: Haiquan Chen, Fudan University

A Single-arm, Phase II Study of Preoperative Gefitinib for Stage II-IIIa NSCLC With Activating EGFR Mutation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of informed consent
  2. Pathologically confirmed non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858 mutation.
  3. Clinically or pathologically confirmed stage II-IIIA
  4. Tolerable to complete resection of lung cancer
  5. Male or female aged 18 years and over
  6. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications
  7. ECOG performance status 0-1.
  8. Life expectancy ≥12 weeks.
  9. Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  10. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x upper limit of normal (ULN).
  11. Adequate renal function: Serum creatinine ≤ 1.5 x upper limit of normal (ULN), and creatinine clearance≥ 60 ml/min.
  12. Measurable disease according to the preset criteria .

Exclusion Criteria:

  1. Known severe hypersensitivity to gefitinib or any of the excipients of this product
  2. Any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
  3. Interstitial lung disease(ILD) or pulmonary fibrosis; impaired pulmonary function (e.g. FEV1 <40% predicted value, artery blood gas PaO2<60mmHg)
  4. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  5. Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer.
  6. Previous or current malignancies of other histologies within the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free survival of 5 years; cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix.
  7. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  8. Eye inflammation or eye infection not fully treated or predisposing factor of this.
  9. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.
  10. Patient who has serious active infection
  11. Patients who harbouring exon 20 T790M mutation.
  12. Pregnancy or breast feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gefitinib
A total of 42 cases of resectable stage II-IIIA NSCLCs patients with EGFR activating mutations will be enrolled in this arm.Gefitinib 250 mg/day oral daily is given to patients after enrolment for 42 days or until disease progression or unacceptable toxicity.
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.
Other Names:
  • Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: at day 42 of gefitinib treatment
at day 42 of gefitinib treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Participants after surgery will receive long-term follow-up for up to 5 years
Participants after surgery will receive long-term follow-up for up to 5 years
Pathologic response rate
Time Frame: Pathologic response rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Pathologic response rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Complete resection rate
Time Frame: Complete resection rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Complete resection rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Number of participants with adverse events
Time Frame: During the neoadjuvant and perioperative period, an expected average of 10 weeks from enrollment
During the neoadjuvant and perioperative period, an expected average of 10 weeks from enrollment
Quality of life (QoL)
Time Frame: During the neoadjuvant period, an expected average of 6 weeks from enrollment
During the neoadjuvant period, an expected average of 6 weeks from enrollment
Disease free survival (DFS)
Time Frame: Participants after surgery will receive long-term follow-up for up to 5 years
Participants after surgery will receive long-term follow-up for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Haiquan Chen, MD, Fudan Univerisity Shanghai Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 14, 2013

First Posted (Estimated)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSIRES0081
  • FUSCC1301 (Other Identifier: Fudan University Shanghai Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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