Comparing maintenance therapy with radiation for lung cancer patients with limited metastases

Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial

This study is testing if adding radiation therapy to standard treatment can help lung cancer patients with a few spots of cancer live better and longer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Tata Memorial Hospital (Government)
• Drugs / interventions: radiation
• Locations: 1 site (Mumbai, Maharashtra)
• Trial ID: NCT05278052 on ClinicalTrials.gov

What this trial studies

This clinical trial compares standard maintenance therapy alone to a combination of local consolidative radiation therapy and standard maintenance therapy for patients with oligometastatic non-small cell lung cancer (NSCLC). The study aims to determine if adding radiation therapy improves outcomes for patients with 1-5 sites of metastatic disease. Participants will be randomly assigned to either the standard treatment group or the experimental group receiving radiation therapy in addition to maintenance therapy. The trial is designed to assess the efficacy and safety of the combined approach in managing this specific cancer population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 with a confirmed diagnosis of NSCLC and 1-5 sites of metastatic disease who have not experienced disease progression after initial systemic therapy.

Not a fit: Patients with more than 5 metastatic sites or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with oligometastatic NSCLC, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with local consolidative radiation therapy in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age \> 18 years
2. Patients with ECOG performance status of 0-2
3. Patients with pathologically proven diagnosis of NSCLC
4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
5. Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease
6. Patients suitable for definitive therapy to the primary disease
7. All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol.
8. Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five.
9. Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician.
10. Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry.
11. 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);
12. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;
13. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule

Exclusion Criteria:

1. Patients with progressive disease after initial standard systemic therapy
2. Patients with oncogene driver mutations
3. Patients with more than 5 sites of oligo metastases
4. Patients with metastatic lesion size of more than 5 cm
5. Patients with more than three metastatic lesion in one organ
6. Patients not suitable for definitive radiation therapy to primary disease
7. Patients not suitable for ablative radiation therapy to metastatic sites
8. Patients with malignant peritoneal disease
9. Patients with malignant pleural effusion
10. Leptomeningeal disease
11. Brain metastases in the brain stem
12. Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI
13. 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;
14. Patients with prior history of radiation therapy to thorax
15. Patients with previous history of malignancy within last 3 years from the date of diagnosis
16. Pregnancy

Where this trial is running

Mumbai, Maharashtra

• Tata Memorial Hospital, Parel — Mumbai, Maharashtra, India (Recruiting)

Study contacts

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

Conditions Oligometastatic Disease; Metastatic Non Small Cell Lung Cancer; Local Consolidative Radiation Therapy; Oligometastatic disease; NSCLC; Maintenance therapy; SABR