NCT07908745Not yet recruitingPhase 3
Reduced-Dose vs Standard-Dose Thoracic Radiotherapy After Induction Chemoimmunotherapy in Older or Frail Stage III NSCLC
Reduced-Dose Versus Standard-Dose Thoracic Radiotherapy After Induction Chemo-Immunotherapy in Older/Frail Patients With Locally Advanced Non-Small Cell Lung Cancer: An Open-Label, Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This is a multicenter, open-label, randomized phase III study in older or frail adults with unresectable stage III non-small cell lung cancer (NSCLC) who are considered unsuitable for concurrent chemoradiotherapy. All participants first receive standard induction chemotherapy plus immunotherapy (4-6 cycles), which is part of routine clinical care and not a study intervention. Patients whose cancer responds (complete response, partial response, or stable disease) may then sign informed consent and be randomly assigned 1:1 to receive either reduced-dose thoracic radiotherapy or standard-dose thoracic radiotherapy. After radiotherapy, both groups receive immune checkpoint inhibitor maintenance therapy for at least 6 months. The main goal is to find out whether reduced-dose radiotherapy is not unacceptably worse than standard-dose radiotherapy in controlling the cancer at 1 year, measured by the 1-year progression-free survival rate. The study will also compare side effects, overall survival, tumor response, and treatment completion. About 276 patients will be enrolled at Ruijin Hospital and six collaborating hospitals in China.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 25 Oct 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Dec 2030
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07908745
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 276
- From 30 Oct 2026 to the primary completion date, 30 Dec 2030
- 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.
Prior treatment
- Prior chemotherapy, immunotherapy, or radiotherapy for NSCLC.
- Major surgery within the past 28 days.
- Contraindication to the use of immunosuppressive drugs.
Other illness
- History of allogeneic organ transplantation, autoimmune disease, immunodeficiency, hepatitis, or HIV infection.
- Uncontrolled comorbid conditions.
- Other active malignancy.
Other
- Leptomeningeal carcinomatosis.
- Pregnancy or breastfeeding.
Who the study is looking for
- Histologically confirmed unresectable stage III non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
- For non-squamous NSCLC: known EGFR-sensitizing mutations must be excluded.
- Considered unsuitable for concurrent chemoradiotherapy by a multidisciplinary team, meeting at least one of the following: ECOG performance status 2; or Age ≥70 years; or Age 65-69 years with Charlson Comorbidity Index (CCI) ≥1; or Age 60-64 years with CCI ≥2.
- Adequate bone marrow, hepatic, and renal function.
- Expected survival of at least 3 months.
- At least one measurable (RECIST 1.1) and irradiable thoracic lesion.
- Adequate pulmonary function: FEV1 \>1 L or \>50% of predicted, and DLCO \>60% of predicted.
- Completion of 4-6 cycles of induction chemotherapy plus immunotherapy.
- Post-induction response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
- Willingness to receive thoracic radiotherapy followed by sequential immune checkpoint inhibitor (ICI) maintenance therapy.
- Provision of written informed consent.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.