Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

Launched by TATA MEMORIAL HOSPITAL · Mar 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of combining a treatment called targeted therapy (TKI) with a special type of radiation therapy known as local consolidative radiation therapy, compared to using TKI alone. This is being tested in patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to a limited number of other places in the body, known as oligometastatic disease. The goal is to see if the addition of radiation can improve outcomes for patients who have a specific mutation in their cancer genes, such as EGFR or ALK/ROS.

To be eligible for this trial, participants need to be at least 18 years old, have a confirmed diagnosis of NSCLC with the right mutations, and have been on TKI treatment for at least 2 to 4 months without their disease getting worse. They should also have a limited number of metastatic sites (1-5) and be able to receive the radiation therapy. If someone joins the trial, they can expect to be closely monitored and may receive either the combined treatment or TKI alone. It's important to note that certain conditions, such as serious heart problems or previous radiation to the chest, could make someone ineligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with pathologically proven diagnosis of NSCLC
• • 2. Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
• • 3. Patients who have received at least 2-4 months of TKI therapy without progression
• • 4. 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)
• • 5. Patients suitable for local consolidative therapy
• 6. 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);
• • 7. Patients with ECOG performance status of 0-2
• • 8. Age \> 18 years
• • 9. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
• Exclusion Criteria:
• • 1. Patients with progressive disease after 2-3 months of initial TKI therapy
• • 2. Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
• • 3. Patients not suitable for local consolidative radiation therapy
• • 4. Patients who are not suitable for further continuation of TKI therapy due to toxicity
• 5. Severe, active co-morbidity defined as follows:
• • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• • Transmural myocardial infarction within the last 6 months;
• • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• • 6. Patients with prior history of radiation therapy to thorax
• • 7. Patients with second malignancy (Synchronous or Metachronous)
• • 8. Pregnancy