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

Official title

A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer

Overview

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).

Interventions

• Drug 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, and then surgery will be provided for patients who are suitable for primary tumor resection.

Primary outcome measures

• The rate of NSCLC converting to resectable tumors [Time frame: Up to 12 weeks]

Secondary outcome measures (9)

• R0 resection rate [Time frame: immediately after the surgery]
• Major pathologic response (MPR) Rate [Time frame: Up to 12 weeks]
• Pathologic complete response (pCR) Rate [Time frame: Up to 12 weeks]
• Tumor downstaging rate [Time frame: Up to 12 weeks]
• Objective response rate (ORR) [Time frame: Up to five years]
• Disease control rate (DCR) [Time frame: Up to five years]
• Event-free survival (EFS) [Time frame: Up to five years]
• The 2-year progression-free survival (PFS) rate [Time frame: Up to two years]
• Overall Survival (OS) [Time frame: Up to five years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shandong Public Health Clinical Center — Jinan

Identifiers

NCT: NCT06709859 · GWLCZXEC2024-56-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗