Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC

NCT ID: NCT07050056

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Resectable NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab plus radiotherapy

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.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

200mg, iv, Q3W, 3-4 cycle

3D-CRT/IMRT

Intervention Type: RADIATION

40Gy in 20 fractions

Interventions

Tislelizumab

200mg, iv, Q3W, 3-4 cycle

Intervention Type: DRUG

3D-CRT/IMRT

40Gy in 20 fractions

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Buhai Wang

Executive Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiangsu Northern People Hospital

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Buhai Wang

Role: CONTACT

wbhself@163.com

+8651487373012

Facility Contacts

Buhai Wang

Role: primary

wbhself@163.com

+8651487373012

Other Identifiers

2025ky220

Identifier Type: -

Identifier Source: org_study_id