Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer

NCT ID: NCT06877299

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-04
• Study Completion Date: 2028-01-01

Brief Summary

This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.

Detailed Description

All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.

Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Study Design

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

Study Groups

Radiation therapy combined with PD-1 inhibitor and chemotherapy group

Low-Dose Radiation(2Gy\*2-3d) +Stereotactic body radiation therapy (10Gy\*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 3 cycles before surgical resection.

Group Type: EXPERIMENTAL

Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

Intervention Type: DRUG

Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

Interventions

Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)

Intervention Type: DRUG

Other Intervention Names

Drug: Tislelizumab; Drug: Chemotherapy

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;

2. Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);

3. Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;

4. At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);

5. Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.

Exclusion Criteria

1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；

2. Patients with known EGFR-sensitive mutations or ALK fusion.

3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;

4. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;

5. Active infection requiring systemic treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

You Lu

Chair of Division of Thoracic Tumor Multimodality Treatment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

You Lu, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

West China Hospital of Sichuan University

Chengdu, China, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxin Xue, MD. Phd

Role: CONTACT

killercell@163.com

18982251798

You Lu, MD. PhD

Role: CONTACT

radyoulu@hotmail.com

+86 189 8060 1763

Facility Contacts

Jianxin Xue, MD. PhD

Role: primary

killercell@163.com

18982251798

References

Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.

Reference Type: BACKGROUND

PMID: 39305910 (View on PubMed)

Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.

Reference Type: BACKGROUND

PMID: 39581197 (View on PubMed)

Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

Reference Type: BACKGROUND

PMID: 35403841 (View on PubMed)

Zhou X, Zhou L, Yao Z, Huang M, Gong Y, Zou B, Zhu J, Liu Y, Peng F, Zhang Y, Yu M, Li Y, Na F, Wu Y, Kang K, Xiu W, Zhang X, Zhou L, Xu Y, Wang J, Wang Y, Yang X, Wu Y, Li R, Zhang Y, Yang Z, Zhou Z, Bai J, Yi X, Tong R, Yin L, Chen C, Niedermann G, Lu Y, Xue J. Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small Cell Lung Cancer Patients. Clin Cancer Res. 2023 Oct 13;29(20):4098-4108. doi: 10.1158/1078-0432.CCR-23-0315.

Reference Type: RESULT

PMID: 37581611 (View on PubMed)

Yin L, Xue J, Li R, Zhou L, Deng L, Chen L, Zhang Y, Li Y, Zhang X, Xiu W, Tong R, Gong Y, Huang M, Xu Y, Zhu J, Yu M, Li M, Lan J, Wang J, Mo X, Wei Y, Niedermann G, Lu Y. Effect of Low-Dose Radiation Therapy on Abscopal Responses to Hypofractionated Radiation Therapy and Anti-PD1 in Mice and Patients With Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2020 Sep 1;108(1):212-224. doi: 10.1016/j.ijrobp.2020.05.002. Epub 2020 May 15.

Reference Type: RESULT

PMID: 32417411 (View on PubMed)

Other Identifiers

IHC-003

Identifier Type: -

Identifier Source: org_study_id