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JY025 is a First-line Treatment for EGFR Mutated NSCLC Phase II and III Clinical Trials of Efficacy and Safety

NCT04874844 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2021-05-10

No results posted yet for this study

Summary

The Phase II study is a multi-center, open, dose escalation and dose extension clinical trial. It is planned to enroll 24 patients; the phase III study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. It is planned to enroll 396 patients, including patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations (EGFR 19 exon deletion or 21 exon mutation).

Conditions

Interventions

BIOLOGICAL

Recombinant anti-VEGFR2 fully human monoclonal antibody (JY025)

The ratio of subjects in the experimental drug group to the placebo control group is 1:1, and you will have a 50% probability of receiving JY025 combined with gefitinib or erlotinib, and a 50% probability of receiving placebo combined with gefitinib Or erlotinib. Blind people, researchers, nurses, research assistants, inspectors, applicants and blind statisticians involved in clinical trials.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Beijing Dongfang Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • yuankai shi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2022-03-30
Completion
2023-06-30

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Entities

Diseases

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 NCT04874844 on ClinicalTrials.gov