Actively Recruiting
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
Led by Tata Memorial Hospital · Updated on 2025-09-10
106
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.
CONDITIONS
Official Title
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-small cell lung cancer confirmed by pathology
- Presence of positive oncogene driver mutation (EGFR or ALK/ROS)
- Received 2 to 4 months of TKI therapy without progression
- 1 to 5 metastatic disease sites excluding primary tumor and regional nodes (less than 3 metastatic lesions in one organ)
- Suitable for local consolidative therapy
- Adequate bone marrow function with ANC ≥ 500 cells/mm3, platelets ≥ 50,000 cells/mm3, hemoglobin ≥ 8.0 g/dl
- ECOG performance status 0 to 2
- Age over 18 years
- Negative pregnancy test within 14 days prior to registration for females of child-bearing potential
You will not qualify if you...
- Progressive disease after 2 to 3 months of initial TKI therapy
- Negative oncogene driver mutations (EGFR, ALK, ROS)
- Unsuitable for local consolidative radiation therapy
- Unsuitable for continued TKI therapy due to toxicity
- Severe active co-morbidities including unstable angina, congestive heart failure, recent myocardial infarction, or respiratory illness requiring hospitalization within 6 months
- Prior radiation therapy to the thorax
- Presence of a second malignancy (synchronous or metachronous)
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
D
Dr. Anil Tibdewal, MD
CONTACT
D
Dr. Jai Prakash Agarwal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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