CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 537 target
Drug / intervention
SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin +2 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓ECOG performance status 0 or 1
  • ✓Previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC
  • ✓Staging based on 8th edition AJCC/UICC staging system
  • ✓Confirmed eligibility for R0 resection with curative intent by attending thoracic surgeon
Key exclusion· 14
  • ✕Any previous systemic anti-cancer therapy for lung cancer
  • ✕Active, known or suspected autoimmune disease
  • ✕Malignancies other than NSCLC within 5 years prior to randomization
  • ✕History of pneumonitis, interstitial lung disease, or severe lung disease affecting lung function assessment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04316364
NCT04316364Phase 3RecruitingUpdate OverdueUpdated 55mo ago · Completion was 38mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Jiangsu HengRui Medicine Co., Ltd.·interventional·Posted Mar 20, 2020·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin, SHR-1316、Chemotherapeutic, and 1 other intervention for Non-Small-Cell Lung Cancer. Currently recruiting, targeting 537 participants across 7 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
2021202220232024202520262027
First PostedMar 20, 2020
Enrollment StartJul 14, 2020
Primary CompletionApr 15, 2023
Study CompletionDec 15, 2026
TodayJul 1, 2026
Enrollment to primary: 2.8 yearsPosted 6.3 years ago

Interventions

SHR-1316、Paclitaxel (Albumin Bound)、Carboplatindrug

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

SHR-1316、Chemotherapeuticdrug

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

Placebo、Chemotherapeuticdrug

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