Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

NCT ID: NCT05215548

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2027-10-31

Brief Summary

Our project is going to enroll patients with stage IV NSCLC with EGFR mutation and evaluate whether primary tumor resection after receiving the afatinib can prolong survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

Detailed Description

In Taiwan, non-small cell lung cancer (NSCLC) has been the leading cause of cancer death, making a phenomenal impact on public health. By understanding the oncogenic driver mutations of NSCLC (e.g. EGFR mutation or ALK rearrangement), the target therapy has taken the place of chemotherapy for its effectiveness and specificity, becoming the new standard of care for stage IV NSCLC. Despite the progress of medical treatment, the majority of patients with stage IV NSCLC still underwent disease progression after a period of time. Noticeably, more than half of the progression was restricted to the original sites of the tumor. It brings up the hypothesis that a combination of local consolidative therapy (e.g. surgery or radial therapy) and medical treatment could be beneficial for these patients. This has been advocated by the latest clinical trials as well.

Our project is going to enroll patients with stage IV NSCLC with EGFR mutation and evaluate whether primary tumor resection after receiving the afatinib can prolong the progression-free survival. This project is supposed to establish a new treatment protocol for stage IV NSCLC with EGFR mutation.

Conditions

NSCLC Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I : Surgery group

The surgery group would receive take 12 weeks of EGFR TKI before randomization. After randomization, the surgery group would receive thoracic surgery with maximal regional control intent. Patients continue afatinib 1 to 2 weeks after surgery until disease progression or unacceptable toxicity. The residual local and metastatic sites of disease could undergo either surveillance or maintenance radio-treatment at the discretion of the treating physician.

Group Type: EXPERIMENTAL

therapeutic thoracic surgery

Intervention Type: PROCEDURE

The surgery group would receive therapeutic thoracic surgery with maximal local regional control intent and would prescribe with maintenance afatinib therapy after operation. Patients continue afatinib 1 to 2 weeks after surgery.

Afatinib

Intervention Type: DRUG

The patient take afatinib treatment for 12 weeks treatment and then receive systemic image study examination before randomization. If exam result showed progression the patient would be excluded from the study. Treatment response was evaluated according to the Response Evaluation Criteria in Solid Tumors (version 1.1).

Group II : Maintenance group

The control group would receive take 12 weeks of EGFR TKI before randomization. After randomization, the control group would receive afatinib until disease progression or unacceptable toxicity. The residual local and metastatic sites of disease could undergo either surveillance or maintenance radio-treatment at the discretion of the treating physician.

Group Type: ACTIVE_COMPARATOR

Afatinib

Intervention Type: DRUG

The patient take afatinib treatment for 12 weeks treatment and then receive systemic image study examination before randomization. If exam result showed progression the patient would be excluded from the study. Treatment response was evaluated according to the Response Evaluation Criteria in Solid Tumors (version 1.1).

Interventions

therapeutic thoracic surgery

The surgery group would receive therapeutic thoracic surgery with maximal local regional control intent and would prescribe with maintenance afatinib therapy after operation. Patients continue afatinib 1 to 2 weeks after surgery.

Intervention Type: PROCEDURE

Afatinib

The patient take afatinib treatment for 12 weeks treatment and then receive systemic image study examination before randomization. If exam result showed progression the patient would be excluded from the study. Treatment response was evaluated according to the Response Evaluation Criteria in Solid Tumors (version 1.1).

Intervention Type: DRUG

Other Intervention Names

Giotrif; BIBW 2992

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed non-small cell lung cancer
• Stage IV non-small cell lung cancer which is amenable to thoracic surgery
• Patients must have one of the following:NSCLC which harbors EGFR exon 19 deletion or L858R mutation.
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Candidate for therapeutic intent surgery to at least one site of disease
• Signed and dated written informed consent prior to admission to the study in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislation

Exclusion Criteria

• Life expectancy <= 12 weeks
• With underlying diseases such as moderate to severe Chronic Obstructive Pulmonary Disease or tuberculosis
• With uncontrol diseases including acute infection, unstable angina or angina in recent 3 months, Heart failure(NYHA≥2), myocardial infarction in recent 6 months, severe arrhythmia, moderate to severe cirrhosis, moderate to severe chronic renal insufficiency, immune insufficiency, any systemic disease with poor prognosis after treatment.
• With Cerebrovascular Accident complicated dependent activities of daily living.
• Any other cancer with active treatment in recent 5 years.
• receive thoracic surgery in the ipsilateral site with the lung cancer previously. （the biopsy surgery required for the diagnosis of lung cancer was not excluded)
• pregnant or breast-feeding woman
• Previous treatment with other EGFR TKI. NOTE: Patients who are receiving initial afatinib (6-12 weeks) outside this study are not excluded
• Disagree to receive Next Generation Sequencing for the lesion specimen after surgery.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

National Taiwan University Cancer Center

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202107141RINB

Identifier Type: -

Identifier Source: org_study_id