Tislelizumab plus thoracic radiotherapy before surgery for resectable non-small cell lung cancer

Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC: A Single Arm, Phase II Clinical Study

This will test whether giving tislelizumab together with thoracic radiotherapy before surgery helps people with resectable NSCLC.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07050056 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial enrolls adults with previously untreated, histologically confirmed resectable stage IB–IIIA NSCLC. Participants receive neoadjuvant tislelizumab combined with thoracic radiotherapy (3D-CRT or IMRT) followed by planned surgical resection. The study requires measurable disease per RECIST v1.1 and collection of PD-L1 pathology for biomarker analyses. Key outcomes include safety, tumor and pathological response, and surgical feasibility.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with previously untreated, resectable stage IB–IIIA NSCLC, ECOG performance status 0–1, adequate organ and pulmonary function for planned lung resection, and tumors suitable for thoracic radiotherapy.

Not a fit: Patients with unresectable or metastatic disease, poor performance status, inadequate organ or pulmonary function, prior systemic therapy for lung cancer, or inability to undergo radiotherapy or surgery are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could shrink tumors before surgery, increase the likelihood of a complete resection, and reduce the chance of recurrence.

How similar studies have performed: Neoadjuvant PD-1/PD-L1 immunotherapy has produced promising pathological response rates in resectable NSCLC in other trials, though combining it with preoperative thoracic radiotherapy is less well studied.

Eligibility criteria

Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form (ICF);
* Aged 18-70 years, regardless of gender;
* Previously untreated, histologically confirmed resectable stage IB-IIIA NSCLC (AJCC 9th edition staging);
* At least one measurable lesion per RECIST v1.1 criteria;
* Willing to provide PD-L1 immunohistochemistry slides and corresponding pathology reports for biomarker evaluation;
* Presence of lesions suitable for radiotherapy as assessed by the study team;
* ECOG performance status of 0-1;
* Adequate organ function;
* Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
* Sufficient pulmonary function to tolerate planned lung resection surgery, as assessed by a surgeon;
* Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Both female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.

Exclusion Criteria:

* Presence of locally advanced unresectable or metastatic disease;
* NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
* Participants with known EGFR mutations or ALK translocations (non-squamous NSCLC subjects must have confirmed EGFR/ALK mutation status);
* Prior systemic anticancer therapy for early-stage NSCLC, including investigational drugs; Contraindications to radiotherapy or inability to undergo radiotherapy;
* History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease requiring steroid treatment;
* Known active tuberculosis (TB) history; Known active infection requiring systemic therapy; Any known or suspected autoimmune disease or immunodeficiency;
* Active hepatitis B infection; Administration of live vaccines within 30 days before the first dose;
* Grade ≥2 peripheral neuropathy;
* Prior treatment with PD-1/PD-L1 inhibitors or drugs targeting other T-cell receptors (e.g., CTLA-4, OX-40, etc.);
* History of severe hypersensitivity to monoclonal antibodies;
* Severe or uncontrolled underlying medical conditions;
* Any condition that, in the investigator's judgment, may confound study results, interfere with the subject's participation, or compromise the subject's best interest in the study.

Where this trial is running

Yangzhou, Jiangsu

• Jiangsu Northern People Hospital — Yangzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Buhai Wang

Conditions: Resectable NSCLC