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Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC.

NCT03623776 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-12-06

No results posted yet for this study

Summary

JS001 (Toripalimab) is a recombinant humanized anti-PD-1 monoclonal antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2. The purpose of this study is to studying neoadjuvant JS001, or JS001 in combination with pemetrexed and carboplatin to see how well it works in treating patients with resectable NSCLC.

Conditions

  • Efficacy and Safety

Interventions

DRUG

JS001

JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.

DRUG

Pemetrexed

Subjects receive pemetrexed of 500 mg/m\^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.

DRUG

Carboplatin

Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.

PROCEDURE

Thoracic Surgery

Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Si-Yu Wang · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2025-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623776 on ClinicalTrials.gov