Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 to 85

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.

More Non-Small Cell Lung Cancer trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment30 (estimated)
SponsorSecond Affiliated Hospital of Nanchang University
Academic / other
Drugs / interventionstislelizumab, chemotherapy
Locations1 site (Nanchang, Jiangxi)
StatusRecruiting
StartedApril 21, 2025
Main results expectedOctober 31, 2028
Study endsDecember 31, 2028
Registry record updatedJune 25, 2026
Trial IDNCT07131319 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

  • Nanchang City, Jiangxi Province
    Nanchang, Jiangxi, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.