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

NCT04316364 | Recruiting Phase 3

• 1 other identifier: SHR-1316-III-303
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 7

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.

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Major pathological response rate (MPR)

  At time of surgery

• Event free survival (EFS)

  Approximately 66 months

Secondary Outcomes (4)

• 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

Study Arms (3)

Treatment group A

EXPERIMENTAL

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

Treatment group B

EXPERIMENTAL

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

Treatment group C

PLACEBO COMPARATOR

Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles

Drug: Placebo、Chemotherapeutic

Interventions

SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin DRUG

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

Treatment group A

SHR-1316、Chemotherapeutic DRUG

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

Treatment group B

Placebo、Chemotherapeutic DRUG

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

Treatment group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

JiangSu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

ZheJiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• YILONG WU, M.D, PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Shi, MD

CONTACT

+86 010-67166319; wei.shi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: July 14, 2020
• Primary Completion: April 15, 2023
• Study Completion (Estimated): December 15, 2026
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

CN (7)