Tislelizumab with platinum-doublet chemotherapy followed by hypofractionated radiotherapy for stage IIIB/C–IV non-squamous NSCLC
Official title: Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer
Run by Zibo Municipal Hospital · NCT07085182 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Zibo Municipal Hospital Academic / other |
| Drugs / interventions | Tislelizumab, chemotherapy |
| Locations | 1 site (Zibo, Shandong) |
| Status | Recruiting |
| Started | January 13, 2024 |
| Main results expected | December 10, 2027 |
| Study ends | December 10, 2028 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT07085182 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
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 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.
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 gone: 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.
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. 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 it's running
-
Zibo Municipal Hospital
Zibo, Shandong, China Recruiting
Study contacts
- Study coordinator: Qiang Wang
- Email: 18953316759@163.com
- Phone: +8618953316759
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Platinum-doublet chemotherapy followed by large-fraction radiotherapy with tislelizumab for advanced non-squamous NSCLC
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.
-
Intestinal Low-Dose Radiotherapy plus Immunochemotherapy to Convert Borderline Resectable or Unresectable Esophageal Squamous Cell Carcinoma
This study tests whether adding a very low dose intestinal radiotherapy with immunochemotherapy can make advanced esophageal squamous cell carcinoma operable for patients who can’t be surgically removed today.
-
Tislelizumab with Anlotinib and Nab-Paclitaxel before surgery for resectable NSCLC
A group of adults with stage II–III non-small cell lung cancer is given tislelizumab plus anlotinib and nab-paclitaxel before surgery to see if the treatment helps shrink tumors and is safe.
-
Adding tislelizumab with or without the probiotic Probio-M9 to pre-surgery chemoradiation for pMMR/MSS locally advanced rectal cancer.
This will see if adding the PD-1 drug tislelizumab, with or without the probiotic Probio-M9, to standard pre-surgery chemoradiation helps adults with pMMR/MSS locally advanced rectal cancer.
-
Adjuvant L-TIL plus tislelizumab after surgery for resectable NSCLC without pCR
This trial tests whether giving liquid tumor-infiltrating lymphocytes (L-TIL) together with the PD-1 blocker tislelizumab after surgery helps people with resectable stage II–IIIB NSCLC who did not achieve a complete response to pre-surgery chemoimmunotherapy.
-
Nephron-sparing tislelizumab and nab-paclitaxel for renal pelvic cancer
This study will try combining tislelizumab and nab‑paclitaxel to shrink HER‑2–expressing renal pelvic tumors in adults eligible for ureteroscopic laser ablation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.