Finding the best organ-targeted radiotherapy plus chemo and PD-1 combinations to trigger abscopal responses in metastatic non-small cell lung cancer without EGFR/ALK mutations
Official title: A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
Run by Xinqiao Hospital of Chongqing · NCT06947694 · Data updated 2026-11-12
This study will try different combinations of radiotherapy, chemotherapy, and PD‑1 immunotherapy to see if they trigger whole-body (abscopal) tumor responses and improve outcomes for people with metastatic NSCLC who do not have EGFR or ALK mutations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 427 (estimated) |
| Sponsor | Xinqiao Hospital of Chongqing Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | July 22, 2025 |
| Trial ID | NCT06947694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with stage IV NSCLC who are negative for driver genes (EGFR, ALK, ROS, BRAF, MET, RET), have 3–6 metastatic lesions, ECOG 0–1, no active brain metastases (or stable lesions), and are eligible for chemo, PD‑1 therapy, and radiotherapy.
✕Probably not a fit
Patients with actionable driver mutations, more than six metastases, uncontrolled brain metastases, severe organ dysfunction, other active malignancies, or ECOG >1 are unlikely to qualify or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, multicenter umbrella trial tests several radioimmunotherapy combination patterns and different organ-target radiotherapy pairings in patients with stage IV non‑small cell lung cancer lacking common driver mutations. Patients receive chemotherapy plus PD‑1 inhibitors alongside targeted radiotherapy to one or more organs according to assigned arms to identify which patterns produce abscopal (distant) tumor responses. The study will collect multimodal omics data and apply machine learning to build a predictive model of the abscopal effect and to explore immune and organ-specific biomarkers. Primary endpoints include survival and occurrence of abscopal responses, with safety and feasibility monitored across arms.
Why it matters
Potential benefit: If successful, the approach could increase survival and produce tumor shrinkage outside the radiation field by identifying optimal organ-targeting and therapy combinations.
How similar studies have gone: Prior case reports and early‑phase studies have shown occasional abscopal responses when combining radiotherapy and immunotherapy, but findings are inconsistent and reliable predictive biomarkers are not established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must meet all of the following inclusion criteria to be enrolled in this study: 1. Non-small cell lung cancer diagnosed initially through pathological histology. 2. There are 3-6 metastatic lesions. 3. No brain metastasis or the lesions are stable. 4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names). 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months. 6. Aged between 18 and 75 years old. 7. Evaluated by PET-CT (including FDG and FMISO, not mandatory). 8. No contraindications for immunotherapy and radiotherapy. 9. The informed consent form has been signed. Exclusion Criteria: * Patients with any of the following criteria are not eligible for enrollment in this study: 1. Those with severe dysfunction of vital organs (heart, liver, kidney). 2. Those accompanied by other malignant tumors. 3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months. 4. Those with a history of mental illness. 5. And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
Where it's running
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the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Principal investigator: Jianguo Sun, MD — the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
- Study coordinator: Jianguo Sun, MD
- Email: sunjg09@aliyun.com
- Phone: 023-68774490
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Optimal combination of radiotherapy schedules and Benmelstobart to induce abscopal responses in metastatic NSCLC
This study will test whether different radiotherapy schedules given with Benmelstobart can cause shrinking of untreated tumors (the abscopal effect) in people with stage IV NSCLC who do not have EGFR/ALK mutations and have multiple metastases.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.