Lung Cancer, Non-small Cell Lung Cancer
Conditions
Keywords
Neoadjuvant, Low Dose Radiotherapy, Stereotactic Body Radiotherapy, Immunotherapy, NSCLC
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.
Interventions
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | 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
| Measure | Time frame | Description |
|---|---|---|
| MPR rate | 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. |
| R0-resection rate | From date of enrollment until one month after resection | — |
| Event-free survival (EFS) | 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. |
Countries
China
Contacts
Primary ContactJianxin Xue, MD. Phd
Backup ContactYou Lu, MD. PhD
Outcome results
None listed