NCT07835789Not yet recruitingPhase 2
Testing Repeat Radiation Therapy for Recurrent Non-small Cell Lung Cancer
A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 18 Dec 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- NRG Oncology
- Diseases
- Lung cancer
- NCT number
- NCT07835789
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 18 Dec 2026 to the primary completion date, 30 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry
- Participants must have recurrent/progressive disease in the lung and/or regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry
- Biopsy to confirm recurrent/progressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required
- A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan
- New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted
- Participants must not have definitive clinical or radiographic evidence of distant metastatic NSCLC at present or in the past
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Not Pregnant and Not Nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Prior thoracic radiotherapy for NSCLC must have been delivered as definitive treatment, as opposed to in the preoperative or postoperative setting. One prior radiotherapy course must meet the specifications, and the radiotherapy plan from that course must be available in Digital Imaging and Communications in Medicine (DICOM) format
- Patients who have received additional prior radiotherapy (i.e., more than one prior radiotherapy course) may be enrolled, provided that only one prior radiotherapy course is deemed to affect the risks associated with treatment with radiotherapy on this study. As examples, prior radiotherapy for an extrathoracic malignancy would likely not affect the risks associated with reirradiation on this study. Prior radiotherapy for breast cancer may be permissible, depending on the extent of lung irradiation. Similarly, prior SBRT for a peripheral lung tumor may be permissible
- No prior SBRT for a central lung tumor, hilar lymph node, or mediastinal lymph node
- Prior lobar and sublobar lung resections are allowed, but prior pneumonectomy is not allowed
- Prior chemotherapy, targeted therapy, and/or immunotherapy for lung cancer is allowed
- No history of CTCAE version (v.) 5.0 grade 2-4 RT pneumonitis or ongoing CTCAE v. 5.0 grade 2-4 pneumonitis from any cause
- No clinically significant interstitial lung disease
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.