Primary Tumor Resection With EGFR TKI for Stage IV NSCLC

NCT05215548 | Active Not Recruiting Phase 2

• 1 other identifier: 202107141RINB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

NSCLC Stage IV

Keywords

epidermal growth factor receptor tyrosine inhibitor; lung adenocarcinoma; surgery

Outcome Measures

Primary Outcomes (1)

• 2 year progression free survival rate

  Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.

  start date of afatinib assessed up to 2 years

Secondary Outcomes (5)

• Progression free survival

  From the start date of afatinib assessed up to 4 years

• Overall survival

  From the start date of afatinib assessed up to 4 years

• Treatment-related adverse events

  From the start date of afatinib assessed up to 4 years

• R0 resection rate

  From the start date of afatinib assessed up to 12 weeks

• resistant mutation events

  12 weeks to 4 years

Study Arms (2)

Group I : Surgery group

EXPERIMENTAL

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.

Procedure: therapeutic thoracic surgery; Drug: Afatinib

Group II : Maintenance group

ACTIVE COMPARATOR

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.

Drug: Afatinib

Interventions

therapeutic thoracic surgery 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.

Group I : Surgery group

Afatinib 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).

Also known as: Giotrif, BIBW 2992

Group I : Surgery group; Group II : Maintenance group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

National Taiwan University Cancer Center

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: September 27, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TW (2)