SFRT with tislelizumab and platinum chemotherapy for initially unresectable stage III NSCLC
Official title: Spatially Fractionated Radiotherapy (SFRT) Synchronized With Tislelizumab Plus Platinum-based Dual-agent Chemotherapy for Induction Treatment of Initially Unresectable Stage Ⅲ Non-small Cell Lung Cancer: A Clinical Study
Run by Second Affiliated Hospital of Nanchang University · NCT07131319 · Data updated 2026-11-12
This trial tests whether adding spatially fractionated radiotherapy (SFRT) to tislelizumab plus platinum doublet chemotherapy can shrink tumors enough to allow surgery in adults with initially unresectable stage III non-small cell lung cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Drugs / interventions | tislelizumab, chemotherapy |
| Locations | 1 site (Nanchang, Jiangxi) |
| Status | Recruiting |
| Started | April 21, 2025 |
| Main results expected | October 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07131319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with pathologically confirmed stage III (T3-4N1-2M0) NSCLC deemed initially unresectable by a multidisciplinary team, ECOG 0-1, and without known EGFR or ALK driver mutations.
✕Probably not a fit
Patients with activating EGFR or ALK mutations, poor performance status, significant comorbidities, or who are already resectable are unlikely to benefit from this induction regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 2/3 study gives concurrent induction spatially fractionated radiotherapy (SFRT) together with tislelizumab and a platinum-based doublet chemotherapy to try to convert initially unresectable stage III NSCLC to resectable disease. About 30 patients without known EGFR or ALK mutations, aged 18 or older with ECOG 0-1 and T3-4N1-2M0 disease, will be enrolled at a single center. Treatment includes SFRT plus systemic tislelizumab and carboplatin-based chemotherapy (with pemetrexed or paclitaxel per histology), followed by restaging to determine surgical candidacy and close safety monitoring. The study's main outcomes are the surgical resection rate after induction and the adverse reactions experienced with this combined approach.
Why it matters
Potential benefit: If successful, this approach could increase the number of patients who become eligible for potentially curative surgery and thereby improve long-term outcomes.
How similar studies have gone: Combining chemoimmunotherapy with radiotherapy to convert unresectable tumors to resectable has shown promise in other studies, but the use of SFRT specifically with tislelizumab is relatively novel and has limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC). Exclusion Criteria: * Has participated in another clinical study using research products within the past 3 weeks.
Where it's running
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Nanchang City, Jiangxi Province
Nanchang, Jiangxi, China Recruiting
Study contacts
- Study coordinator: jing cai Jing Cai
- Email: cjdl879@163.com
- Phone: 15270905381
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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.