Non-Small-Cell Lung Cancer
Conditions
Brief summary
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
Interventions
DRUGSHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
DRUGSHR-1316、Chemotherapeutic
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
DRUGPlacebo、Chemotherapeutic
Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system * Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent * Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing * Measurable disease as defined by RECIST v1.1 * Adequate organ function * Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment
Exclusion criteria
* Any previous systematic anti-cancer therapy for lung cancer * With active, known or suspected autoimmune disease of autoimmune disease * Malignancies other than NSCLC within 5 years prior to randomization * Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function * Significant history of cardiovascular and cerebrovascular disease * Significant haemorrhagic disease * Has an arteriovenous thrombotic events * Has a known history of human immunodeficiency virus (HIV) infection * Has a known active Hepatitis B or Hepatitis C * Allergic to monoclonal antibodies or other protein drugs * Allergic to the intervention regimens * Pregnant or lactating women * Has known psychiatric or substance abuse disorders * Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR) | At time of surgery |
| Event free survival (EFS) | Approximately 66 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Approximately 96 months |
| Pathology complete response (pCR) | At time of surgery |
| Objective response rate (ORR) | prior to surgery |
| Disease-Free Survival (DFS) | Approximately 66 months |
Countries
China
Contacts
Primary ContactVivian Shi, MD
Outcome results
None listed