Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC

Northern Jiangsu People's Hospital

Status and phase: Enrolling; Phase 2

Conditions: Resectable NSCLC

Treatments: Drug: Tislelizumab; Radiation: 3D-CRT/IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT07050056

2025ky220

Details and patient eligibility

About

This study aims to explore the efficacy and safety of radiotherapy combined with immunotherapy in the neoadjuvant treatment of resectable NSCLC.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tislelizumab plus radiotherapy

Experimental group

Description:

Tislelizumab IV 200mg, d1, Q3W; concurrently combined with 40Gy/20f radiotherapy (3D-CRT/IMRT, IMRT, targeting only the lesion and positive lymph nodes), for 3-4 cycles.

Treatment:

Radiation: 3D-CRT/IMRT

Drug: Tislelizumab