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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Shandong Public Health Clinical Center
RECRUITING
Jinan
Contact Information
Primary
Hua Zhang, PhD
95192789@qq.com
0531-83347512
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Afatinib plus chemotherapy
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.
Related Therapeutic Areas
Sponsors
Leads: Shandong Public Health Clinical Center