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

StatusRecruiting
PhasePhase 3
Started2020-07-14
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 4, 2021 (before its estimated April 15, 2023 completion). Its status may not reflect the trial's current state.

Amendment history

2021-10-27
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2025-05→2023-04-15
Completion date2026-05→2026-12-15
Enrollment target456→537
Study arms2→3
InterventionsCarboplatin (Drug), Paclitaxel (Albumin Bound) (Drug), Placebo (Drug), SHR-1316 (Drug)→Placebo、Chemotherapeutic (Drug), SHR-1316、Chemotherapeutic (Drug), SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin (Drug)
Eligibility criteria+136 characters
[...] ing 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.
Secondary endpointsdetails revised at 1 of 4 entries
2021-03-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-05→confirmed 2020-07-14
Study sites0→7
2020-03-19
Original filing
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.
Trial Details
NCT Number NCT04316364
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Non-Small-Cell Lung Cancer
Enrollment 537 participants
Start Date 2020-07-14
Primary Completion 2023-04-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2021-11-04