Clinical trial · Interventional
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC
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
NCT05277844CI-TRIAL-00094881TARGET-01recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Driver Mutation | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Oligometastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Consolidative Radiation Therapy | Radiation | — | UNRESOLVED |
| TKI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Continuation of TKI therapy alone
- description
- Patients in this arm will continue to receive standard treatment of TKI alone
- interventionNames
- Drug: TKI
- type
- EXPERIMENTAL
- label
- Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to 1-5 sites
- description
- Patients will receive local consolidate radiation therapy to all oligo-metastatic sites plus radiation therapy to primary disease in addition to TKI
- interventionNames
- Radiation: Local Consolidative Radiation Therapy
- Drug: TKI
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDTibdewal A, Agarwal J, Mummudi N, Noronha V, Prabhash K, Patil V, Purandare N, Janu A, Kaushal R, Kannan S. Protocol for a phase II randomised controlled trial of TKI alone versus TKI and local consolidative radiation therapy in patients with oncogene driver-mutated oligometastatic non-small cell lung cancer. BMJ Open. 2021 Feb 15;11(2):e041345. doi: 10.1136/bmjopen-2020-041345. PMID 33589450