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

Recruiting now · Phase 2

Conditions studied: Oligometastatic Disease, Non-small Cell Lung Cancer, Driver Mutation

In brief

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.

Key facts

Study ID: NCT05277844
Run by: Tata Memorial Hospital
People needed: 106
Starts: 2019-11-11
Expected to finish: 2027-11-11
Last updated by the study team: 2025-09-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
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 prior history of radiation therapy to thorax
Patients with second malignancy (Synchronous or Metachronous)
Pregnancy

Where it is running

Tata Memorial Hospital — Mumbai, Maharashtra, India (enrolling)

Full record on ClinicalTrials.gov

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