Neoadjuvant low-dose radiation and SBRT with tislelizumab plus platinum chemotherapy for stage IIA–IIIB NSCLC

Is this trial a fit for you?

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 single-arm phase II protocol in which all eligible patients receive low-dose radiotherapy combined with partial stereotactic body radiotherapy, followed within seven days by the PD-1 inhibitor tislelizumab plus platinum-based chemotherapy given every three weeks for three cycles as neoadjuvant treatment. Surgery is planned 4 to 6 weeks (±7 days) after completing the final cycle of immunochemotherapy. The main endpoint is the pathological complete response rate in resected primary tumors and lymph nodes. Eligible patients are adults (18–75) with untreated, resectable or potentially resectable stage IIA–IIIB NSCLC, with exclusions for small cell histology, known EGFR-sensitive mutations or ALK fusions, and prior PD-1/PD-L1 therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);
3. Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
4. At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
5. Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.

Exclusion Criteria:

1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
2. Patients with known EGFR-sensitive mutations or ALK fusion.
3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;
4. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
5. Active infection requiring systemic treatment.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, China, China Recruiting

Study contacts

• Principal investigator: You Lu, MD. PhD — Study Principal Investigator
• Study coordinator: Jianxin Xue, MD. Phd
• Email: killercell@163.com
• Phone: 18982251798

Similar studies

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

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Does the time of day for PD-1/PD-L1 therapy affect response in NSCLC and HNSCC

  In people with advanced NSCLC or resectable head and neck cancer, this study tests whether receiving PD-1/PD-L1 therapy in the morning versus the afternoon changes treatment outcomes.

  Recruiting Phase 2 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07630168

• Romiplostim N01 plus ATRA for persistent chemotherapy-induced low platelets after remission from gynecologic, breast, or lung cancer

  This trial tests whether adding ATRA to Romiplostim N01 helps people keep a safe platelet count after finishing chemotherapy for certain cancers.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07586826

• 3-D virtual resection to predict lung function after VATS anatomical lung surgery

  The study will test whether a 3-D virtual resection from thin-slice CT scans can better predict lung function after VATS lobectomy or segmentectomy for people with non-small cell lung cancer.

  Recruiting National Taiwan University Hospital · Taipei · NCT07436598

• RC148 plus platinum chemotherapy versus tislelizumab plus platinum chemotherapy for first-line squamous non-small cell lung cancer

  This study tests whether RC148 with carboplatin and paclitaxel works better than tislelizumab with the same chemotherapy for people with newly diagnosed advanced or metastatic squamous non-small cell lung cancer who have not had prior systemic treatment.

  Recruiting at 78 sites Phase 3 RemeGen Co., Ltd. · Hefei, Anhui and 77 other locations · NCT07416474

• Precise Exercise Regimen for Cancer Care: a small pilot in stage II/III NSCLC

  This pilot tests the PERCC exercise program to see if it’s feasible for adults with stage II–III non-small cell lung cancer who are planned for neoadjuvant therapy and surgery.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07412041

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.