Study on Using Radiation Before Targeted Therapy to Delay Progression in Advanced Non-Small Cell Lung Cancer
Sponsor: Medical College of Wisconsin
ClinicalTrials ID:NCT06305715
This clinical trial is exploring whether using radiation therapy on the main lung tumor can help delay the progression of advanced non-small cell lung cancer (NSCLC) in patients who have specific genetic mutations and are starting treatment with targeted therapy.
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Program Overview
The study aims to find out if giving radiation therapy to the main lung tumor can help patients with advanced non-small cell lung cancer (NSCLC) live longer without their cancer getting worse. This is for patients who have not yet received any treatment and have specific genetic mutations. After radiation, patients will start on a targeted therapy called a tyrosine kinase inhibitor (TKI) to see if this combination can improve their outcomes.
Description
This study is divided into two parts and involves patients with advanced non-small cell lung cancer (NSCLC) who have specific genetic mutations. In the first part, up to 34 patients who have not received any previous treatment will receive radiation therapy to their main lung tumor. The radiation doses will vary based on the doctor's decision, ranging from 24 to 60 Gy over 1 to 15 sessions.
After completing radiation therapy, patients with a specific genetic mutation that can be targeted will move on to the second part of the study. In this part, 29 patients will receive a targeted therapy called a tyrosine kinase inhibitor (TKI), which is chosen by their doctor according to national guidelines. Patients will be monitored every three months to check if their cancer is progressing and to assess their overall survival.
Eligibility Criteria
Exclusion Criteria
- Expected to live less than 3 months.
- Cannot swallow pills or have digestive issues that affect medication absorption.
- Patients with other cancers can join if those cancers won't affect the study's safety or effectiveness.
- Must not have unresolved side effects from previous cancer treatments that are severe, except for hair loss.
- Must not have medical issues that prevent safe radiation therapy, as determined by the doctor.
- Women must not be pregnant or breastfeeding, and must have a negative pregnancy test within 14 days before joining the study.
- Women who can become pregnant and sexually active men must use effective birth control starting 14 days before joining the study, during the study, and for 4 months after the last targeted therapy treatment.
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