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

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

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.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zibo Municipal Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Tislelizumab
• Locations: 1 site (Zibo, Shandong)
• Trial ID: NCT07198217 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Zibo, Shandong

• Zibo Municipal Hospital — Zibo, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Qiang Wang

Conditions NSCLC; Tislelizumab; Chemotherapy; Hypofractionated Radiotherapy