Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC

Launched by NORTHERN JIANGSU PEOPLE'S HOSPITAL · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with early-stage lung cancer that can be removed by surgery, called resectable non-small cell lung cancer (NSCLC). The study is testing whether combining a type of immunotherapy drug called tislelizumab with radiation therapy before surgery can help improve outcomes. Immunotherapy helps the body’s immune system fight cancer, and radiation therapy uses high-energy rays to target cancer cells. Researchers want to see if using both treatments together before surgery is safe and effective.

To take part, patients need to be between 18 and 70 years old, have a confirmed diagnosis of certain stages of lung cancer that can be surgically removed, and be healthy enough to undergo surgery. Participants should not have had prior treatment for their lung cancer and must have tumors suitable for radiation. The study team will carefully check your overall health, lung function, and other factors to make sure the treatment is safe for you. During the trial, participants will receive the combined treatments before surgery and will be closely monitored with regular visits and tests. This study is not yet recruiting patients, but it may offer a new option for those eligible who want to try a treatment that could improve their chance of successful surgery and recovery.

Gender

ALL

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.