MedTrace Logo

First-line Replacement Maintenance of Envafolimab in Advanced NSCLC

NCT05465733 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-07-20

No results posted yet for this study

Summary

This study is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the informed consent form, were screened to meet the criteria for inclusion and exclusion. Standard, will receive Envafolimab combined with chemotherapy/Envafolimab single-agent first-line maintenance therapy until disease progression, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other protocol-specified conditions that should be discontinued Circumstances, whichever occurs first.

Conditions

  • Non-Small-Cell Lung

Interventions

DRUG

Envafolimab;Pemetrexed

single agent, 300mg Q3W IH until disease progressed,The duration of treatment with Envafolimab should not exceed 2 years.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT05465733 on ClinicalTrials.gov