Tislelizumab Combined With Thoracic Radiotherapy as Neoadjuvant Therapy for Resectable NSCLC

NCT07050056 | Recruiting Phase 2

• 1 other identifier: 2025ky220
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders.

  18 months

Secondary Outcomes (2)

• MPR Rate

  18 months

• 1-year EFS Rate

  Baseline up to 1 years

Study Arms (1)

Tislelizumab plus radiotherapy

EXPERIMENTAL

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.

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

Interventions

3D-CRT/IMRT RADIATION

40Gy in 20 fractions

Tislelizumab plus radiotherapy

Tislelizumab DRUG

200mg, iv, Q3W, 3-4 cycle

Tislelizumab plus radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Jiangsu Northern People Hospital

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Central Study Contacts

Buhai Wang

CONTACT

+8651487373012; wbhself@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

CN (1)