Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTata Memorial Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Patients with pathologically proven diagnosis of NSCLC
Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
Patients who have received at least 2-4 months of TKI therapy without progression
Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
Disqualifiers
Patients with progressive disease after 2-3 months of initial TKI therapy
Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
Patients not suitable for local consolidative radiation therapy
Patients who are not suitable for further continuation of TKI therapy due to toxicity
Trial design
Treatments tested in this trial
- Local Consolidative Radiation Therapy
- TKI
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov