SFRT with tislelizumab and platinum chemotherapy for initially unresectable stage III NSCLC
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
PHASE2; PHASE3 · Second Affiliated Hospital of Nanchang University · NCT07131319
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Nanchang University (other) |
| Drugs / interventions | tislelizumab, chemotherapy |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT07131319 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanchang, Jiangxi
- Nanchang City, Jiangxi Province — Nanchang, Jiangxi, China (RECRUITING)
Study contacts
- Study coordinator: jing cai Jing Cai
- Email: cjdl879@163.com
- Phone: 15270905381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Small Cell Lung Cancer