Combining targeted therapy with radiation for specific 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

This study is testing if adding radiation therapy to a targeted cancer treatment can help people with a specific type of lung cancer feel better compared to just using the targeted treatment alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Tata Memorial Hospital (other gov)
• Drugs / interventions: radiation
• Locations: 1 site (Mumbai, Maharashtra)
• Trial ID: NCT05277844 on ClinicalTrials.gov

What this trial studies

This Phase II randomized controlled trial investigates the effectiveness of combining targeted therapy with local consolidative radiation therapy (LCRT) compared to targeted therapy alone in patients with oncogene driver mutated oligometastatic non-small cell lung cancer (NSCLC). Eligible participants will be randomly assigned to receive either TKI therapy alone or TKI therapy alongside LCRT to treat localized disease and up to five metastatic sites. The study aims to evaluate the potential benefits of adding radiation therapy to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with oncogene driver mutations in NSCLC who have limited metastatic disease and have been on TKI therapy without progression.

Not a fit: Patients with extensive metastatic disease or those who have not responded to TKI therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with oligometastatic NSCLC.

How similar studies have performed: Previous studies have shown promising results with similar combinations of targeted therapies and radiation in treating oligometastatic cancers.

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

Where this trial is running

Mumbai, Maharashtra

• Tata Memorial Hospital — Mumbai, Maharashtra, India (RECRUITING)

Study contacts

• Principal investigator: Dr. Anil Tibdewal, MD — Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India
• Study coordinator: Dr. Anil Tibdewal, MD

Conditions: Oligometastatic Disease, Non-small Cell Lung Cancer, Driver Mutation, Oligometastatic NSCLC, Driver mutation, TKI, Local consolidative therapy, SABR