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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Non-Small-Cell Lung Cancer

Treatments: Drug: Placebo、Chemotherapeutic; Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin; Drug: SHR-1316、Chemotherapeutic

Study type: Interventional

Funder types: Industry

Identifiers

NCT04316364

SHR-1316-III-303

Details and patient eligibility

About

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.

Enrollment: 537 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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537 participants in 3 patient groups, including a placebo group

Treatment group A

Experimental group

Description:

Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles

Treatment:

Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin

Treatment group B

Experimental group

Description:

Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles

Treatment:

Drug: SHR-1316、Chemotherapeutic

Treatment group C

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo、Chemotherapeutic