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

Phase 2

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Afatinib plus chemotherapy as conversion treatment

• Registration Number: NCT06709859
• Lead Sponsor: Shandong Public Health Clinical Center

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.

Detailed Description

This single-arm, open-label, prospective phase II clinical trial was designed 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.

The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2025-01-01
• Primary Completion: 2026-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afatinib plus chemotherapy	Afatinib plus chemotherapy as conversion treatment	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.

Primary Outcome Measures

Name	Time	Method
The rate of NSCLC converting to resectable tumors	Up to 12 weeks	The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to five years	The length of time after initial administration the patient remains alive
R0 resection rate	immediately after the surgery	The proportion of R0 resection in patients who receive surgery
Major pathologic response (MPR) Rate	Up to 12 weeks	The proportion of patients who achieve MRP among those receiving surgery
Pathologic complete response (pCR) Rate	Up to 12 weeks	The proportion of patients who achieve pCR among those receiving surgery
Tumor downstaging rate	Up to 12 weeks	The proportion of patients who reach the successful downstaging criteria for NSCLC
Objective response rate (ORR)	Up to five years	The proportion of patients who have a complete response (CR) or partial response (PR).
Disease control rate (DCR)	Up to five years	The proportion of patients who have a best overall response of CR, PR, or stable disease (SD).
Event-free survival (EFS)	Up to five years	The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause.
The 2-year progression-free survival (PFS) rate	Up to two years	The proportion of patients who are event-free.

Trial Locations

Locations (1)

Shandong Public Health Clinical Center; 🇨🇳 Jinan, Shandong, China