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NCT Number: NCT06877299

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, China, 610041

Location status: Recruiting

Location contact

Jianxin Xue, MD. PhD

CONTACT

[email protected]

18982251798

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years;
  • 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);
  • Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
  • At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
  • Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.

Exclusion criteria

  • The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC);
  • Patients with known EGFR-sensitive mutations or ALK fusion.
  • 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;
  • 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;
  • Active infection requiring systemic treatment.

Treatment and study plan

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

Drug

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

Other names: Drug: Tislelizumab, Drug: Chemotherapy

Primary outcomes

  1. pCR rate

    Time frame: From date of enrollment until one month after resection

    pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin stained slides of the resected lung specimen and lymph nodes following completion of neoadjuvant therapy

Secondary outcomes

  1. MPR rate

    Time frame: From date of enrollment until one month after resection

    mPR is defined as ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes.

  2. R0-resection rate

    Time frame: From date of enrollment until one month after resection

  3. Event-free survival (EFS)

    Time frame: up to 2 years

    EFS is defined as the time from enrollment to radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxin Xue, MD. Phd

CONTACT

[email protected]

18982251798

You Lu, MD. PhD

CONTACT

[email protected]

+86 189 8060 1763

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients With Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 14, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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