Status:
RECRUITING
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Oligometastatic Disease
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study. Arm 1: Continuation of TKI therapy alone Arm 2: ...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 11 2027
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05277844
Start Date
November 11 2019
End Date
November 11 2027
Last Update
September 10 2025
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012