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

ConditionsLung CancerNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Radiation therapy combined with PD-1 inhibitor and chemotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR rate

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

Time frame
From date of enrollment until one month after resection

Secondary outcomes

1

MPR rate

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

Time frame
From date of enrollment until one month after resection
2

R0-resection rate

Time frame
From date of enrollment until one month after resection
3

Event-free survival (EFS)

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.

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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