Lung cancer trial: can radiation boost targeted drugs for limited metastases?
NCT ID NCT05277844
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase II trial is for people with a specific type of non-small cell lung cancer that has spread to only a few places in the body (oligometastatic) and has a driver mutation like EGFR or ALK. Participants have already been on a targeted therapy pill (TKI) for 2-4 months without their cancer getting worse. Half will continue TKI alone, and the other half will also receive radiation to all known cancer spots. The study aims to see if adding radiation delays cancer progression and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tyrosine kinase inhibitor (TKI) and local consolidative radiation therapy
- What this could lead to
- If successful, this could show that adding radiation to standard TKI therapy helps control cancer spread and delays progression in patients with a limited number of metastases.
- What could go wrong
- This is a phase II trial with only 106 participants, so results are preliminary. Adding radiation may increase side effects without improving survival, and the benefit may not apply to all mutation types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tata Memorial Hospital
RECRUITINGMumbai, Maharashtra, 400012, India
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