Tislelizumab with platinum-doublet chemotherapy followed by hypofractionated radiotherapy for stage IIIB/C–IV non-squamous NSCLC

Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer

This trial tests whether adding Tislelizumab to platinum-doublet chemotherapy followed by hypofractionated radiotherapy can help people with stage IIIB/C–IV non‑squamous non‑small cell lung cancer who have not had prior systemic therapy.

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: Tislelizumab, chemotherapy
• Locations: 1 site (Zibo, Shandong)
• Trial ID: NCT07085182 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm phase II trial giving Tislelizumab together with platinum-based doublet chemotherapy, followed by hypofractionated radiotherapy and continued Tislelizumab. The study will track tumor response and safety outcomes in patients with stage IIIB/C–IV non-squamous NSCLC and ECOG performance status 0–2. Key exclusions include known driver mutations (EGFR, ALK, ROS1, RET, BRAF, MET), uncontrolled autoimmune disease, prior systemic therapy, and pregnancy or lactation. All treatments and follow-up are conducted at a single center in Zibo, Shandong.

Who should consider this trial

Good fit: Adults 18–75 years old with histologically or cytologically confirmed stage IIIB/C–IV non‑squamous NSCLC, ECOG 0–2, no prior systemic therapy, no targetable driver mutations, and no uncontrolled autoimmune disease are the intended candidates.

Not a fit: Patients with known actionable driver mutations, uncontrolled autoimmune disorders, prior systemic therapy, or who are pregnant or breastfeeding are unlikely to be eligible or benefit from this regimen.

Why it matters

Potential benefit: If effective, this approach could offer an additional treatment option for patients who cannot tolerate standard concurrent chemoradiotherapy, potentially improving disease control and outcomes.

How similar studies have performed: Combinations of PD‑1 inhibitors with chemotherapy have shown benefit in advanced NSCLC, but the specific sequence of Tislelizumab plus chemotherapy followed by hypofractionated radiotherapy in this patient group is relatively novel and not yet widely validated.

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. Patients who have not received prior systemic therapy;

Exclusion Criteria:

1. Patients with uncontrolled autoimmune diseases;
2. Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.;
3. Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
4. Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment;
5. Patients with known allergies or contraindications to the study drug or its excipients;
6. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
7. 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;
8. 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