Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Platinum-doublet chemotherapy followed by large-fraction radiotherapy with tislelizumab for advanced non-squamous NSCLC

Official title: Real World Study of Platinum Containing Dual Drug Chemotherapy Followed by Large Fractionated Radiotherapy Combined withTislelizumab in Stage IIIB/C-IV Non-small Cell Lung Cancer Patient

Run by Zibo Municipal Hospital · NCT07198217 · Data updated 2026-11-12

We will try platinum-based doublet chemotherapy followed by large-fraction radiotherapy together with tislelizumab in people with stage IIIB/C–IV non-squamous non-small cell lung cancer who cannot tolerate concurrent chemoradiotherapy.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment20 (estimated)
SponsorZibo Municipal Hospital
Academic / other
Drugs / interventionschemotherapy, Tislelizumab
Locations1 site (Zibo, Shandong)
StatusRecruiting
StartedMay 25, 2021
Main results expectedSeptember 28, 2025
Study endsOctober 10, 2027
Registry record updatedSeptember 30, 2025
Trial IDNCT07198217 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–75 years with stage IIIB/C–IV non-squamous NSCLC, ECOG performance status 0–2, without actionable driver mutations, and physically able to receive platinum-doublet chemotherapy, hypofractionated radiotherapy, and immunotherapy are ideal candidates.

Probably not a fit

Patients with uncontrolled autoimmune disease, recent unstable immune-related adverse events, known targetable driver mutations, recent systemic therapy within 3 months, or poor performance status (ECOG >2) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-center interventional protocol for patients with stage IIIB/C–IV non-squamous NSCLC. Participants receive platinum-based doublet chemotherapy, then undergo hypofractionated (large-fraction/SBRT-like) radiotherapy combined with tislelizumab, followed by continued tislelizumab maintenance. The study enrolls adults with ECOG 0–2 and excludes tumors with actionable driver mutations (EGFR, ALK, BRAF, ROS1, RET, MET, etc.). The primary focus is on observing tumor response, safety, and tolerability of this sequential chemo–radiation–immunotherapy approach.

Why it matters

Potential benefit: If successful, the regimen could offer a tolerable alternative for patients who cannot receive concurrent chemoradiation and may improve local control and progression-free outcomes.

How similar studies have gone: Other trials combining chemoradiation and immune checkpoint blockade (for example consolidation PD‑L1/PD‑1 therapy after chemoradiation) have shown benefit in locally advanced NSCLC, but the specific sequence of platinum-doublet chemo followed by hypofractionated radiotherapy with tislelizumab is less well tested and relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
3. Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
4. Tumor histology or hematology confirms no EGFR mutations and no mutations or positive driver genes for ALK, BRAF, ROS1, RET, MET, etc or Targeted drug therapy leads to drug resistance progression

Exclusion Criteria:

1. Patients with uncontrolled autoimmune diseases;
2. Patients who have experienced autoimmune reactions within the past 6 months and whose conditions have not improved or are unstable after corresponding treatments, such as pneumonia, thyroiditis, myocarditis, etc. that have not stabilized after treatment;
3. Patients who have previously received systemic chemotherapy, or adjuvant or neoadjuvant therapy, and the time from the last treatment to recurrence is less than 3 months;
4. Patients with known allergies or contraindications to the study drug or its excipients;
5. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
6. Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
7. Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.

Where it's running

  • Zibo Municipal Hospital
    Zibo, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.