Radiation Added to Targeted Pills for Lung Cancer Spread to Few Sites
Tests radiation plus targeted pills against targeted pills alone in lung cancer.
Plain-language title generated from the registry record
Registry title: Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
Key facts
- Where
- Mumbai, IndiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT05277844, who can take part
Where in India
- Tata Memorial HospitalMumbai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Hospital
- Trial code
- NCT05277844
- Record updated
- 10 September 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Patients not suitable for local consolidative radiation therapy; Patients who are not suitable for further continuation of TKI therapy due to toxicity; Patients with prior history of radiation therapy to thorax; Patients with progressive disease after 2-3 months of initial TKI therapy; 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; Patients with second malignancy (Synchronous or Metachronous); Patients with negative oncogene driver mutations (EGFR/ALK/ROS); Pregnancy.