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
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.
• 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)
• Patients suitable for local consolidative therapy
• Adequate end-organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:
‣ Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
⁃ Platelets ≥ 50,000 cells/mm3;
⁃ Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable);
• Patients with ECOG performance status of 0-2
• Age \> 18 years
• For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration