Preoperative Stereotactic Body Radiotherapy and Platinum-based Doublet Chemotherapy Plus Tislelizumab (Immunotherapy) for Operable Stage II to III EGFR Wild-type Non-small Cell Lung Cancer

Sun Yat-sen University1 site in 1 country46 target enrollmentApril 24, 2022

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsSBRT Tislelizumab

DrugsTislelizumab

Overview

Phase: Phase 2
Intervention: SBRT
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Sun Yat-sen University
Enrollment: 46
Locations: 1
Primary Endpoint: Major Pathological Response (MPR)
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out the effectiveness stereotactic body radiation therapy (SBRT) followed by two cycles of Tislelizumab (PD-1 inhibitor) with chemotherapy as treatment for operable stage II to III non-small cell lung cancer (NSCLC) prior to surgery.

Registry

clinicaltrials.gov

Start Date

April 24, 2022

End Date

May 31, 2026

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Yang Hong

Prof.

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Patient has histologically or cytologically proven clinical stages II and III NSCLC (according to the 8th AJCC edition) and is considered eligible for surgical resection with curative intent. Besides, T3-4N2 stage IIIB disease deemed potentially resectable by MDT group is also allowed.
•Measureable disease, as defined by RECIST v1.
•Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
•EGFR mutational status should be tested in all non-squamous carcinoma, and only patients with non-EGFR-TKI sensitizing mutation (19del or L858R) are allowed. For squamous cell carcinoma, EGFR mutational test is not required.
•Age \> 18 years at time of study entry
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Adequate normal organ and marrow function as defined below:
•Haemoglobin ≥ 9.0 g/dL
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
•Platelet count ≥ 100 x 109/L (\>100,000 per mm3)

Exclusion Criteria

•Participation in another clinical study with an investigational product during the last 3 weeks.
•History of another primary malignancy except for:
•Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence.
•Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
•Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ, in-situ urinary bladder cancer , treated localized prostate cancer and ductal carcinoma-in situ.
•Indolent hematological malignancies
•Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal,inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•Any unresolved toxicity (CTCAE grade 2) from therapy for a prior malignancy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
•Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
•Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).

Arms & Interventions

Neoadjuvant SBRT plus immunochemotherapy

Stereotactic body radiation therapy (8Gy\*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 2 cycles before surgical resection

Intervention: SBRT

Neoadjuvant SBRT plus immunochemotherapy

Intervention: Tislelizumab

Outcomes

Primary Outcomes

Major Pathological Response (MPR)

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

MPR is defined as ≤10% residual viable tumor in the resected specimen

Secondary Outcomes

Disease-free survival(From date of SBRT start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years , then yearly thereafter till year 5)
Resected rate(From date of enrollment to an average of 18 weeks after the first dose)
Pathologic Complete response (PCR)(From date of enrollment until one month after resection)