RecruitingPhase 2NCT06709859

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

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


Sponsor

Shandong Public Health Clinical Center

Enrollment

30 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the targeted drug afatinib to chemotherapy can shrink non-small cell lung cancer (NSCLC) tumors enough to make surgery possible in patients who were initially told their cancer couldn't be removed. **You may be eligible if...** - You have been diagnosed with Stage III non-small cell lung cancer that cannot be surgically removed - Your tumor has a specific genetic change called an EGFR sensitive mutation (found by a tissue or blood test) - You are in good general health (able to carry out daily activities) - You have not received prior chemotherapy or radiation for this lung cancer **You may NOT be eligible if...** - Your cancer is a mixed type (e.g., combines small cell and non-small cell) - You have fluid around the lungs caused by cancer - You have uncontrolled bowel conditions like Crohn's disease or severe diarrhea Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAfatinib 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.


Locations(1)

Shandong Public Health Clinical Center

Jinan, Shangdong, China

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NCT06709859


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