A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small-Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
* Drug: SHR-1316、Chemotherapeutic
* Drug: Placebo、Chemotherapeutic


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles | Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin<br>* 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<br>|
| Experimental: Treatment group B<br>Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles | Drug: SHR-1316、Chemotherapeutic<br>* 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<br>|
| Placebo Comparator: Treatment group C<br>Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles | Drug: Placebo、Chemotherapeutic<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathological response rate (MPR) |  | At time of surgery | 
| Event free survival (EFS) |  | Approximately 66 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |