Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC

NCT06709859 | Recruiting Phase 2

• 1 other identifier: GWLCZXEC2024-56-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Conversion Therapy; Afatinib

Outcome Measures

Primary Outcomes (1)

• The rate of NSCLC converting to resectable tumors

  The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.

  Up to 12 weeks

Secondary Outcomes (9)

• R0 resection rate

  immediately after the surgery

• Major pathologic response (MPR) Rate

  Up to 12 weeks

• Pathologic complete response (pCR) Rate

  Up to 12 weeks

• Tumor downstaging rate

  Up to 12 weeks

• Objective response rate (ORR)

  Up to five years

Study Arms (1)

Afatinib plus chemotherapy

EXPERIMENTAL

Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment (afatinib 40mg qd; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for non-squamous carcinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then surgery will be provided for patients who are suitable for primary tumor resection. Maintenance treatment with afatinib 40mg qd will continue up to 2 years or disease progression after surgery.

Drug: Afatinib plus chemotherapy as conversion treatment

Interventions

Afatinib plus chemotherapy as conversion treatment DRUG

Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.

Afatinib plus chemotherapy

Eligibility Criteria

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

You may qualify if:

• Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
• Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
• ECOG Performance Status of 0-1
• At least one measurable lesion according to RECIST 1.1
• Adequate organ and marrow function

You may not qualify if:

• Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
• The presence of malignant pleural effusion
• Prior systemic anti-cancer therapy for non-small cell lung cancer
• Prior local radiotherapy for NSCLC
• Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment

Sponsors & Collaborators

• Shandong Public Health Clinical Center: lead

Study Sites (1)

Shandong Public Health Clinical Center

Jinan, Shangdong, 250000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hua Zhang, PhD

  Shandong Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhang, PhD

CONTACT

0531-83347512; 95192789@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)