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Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive NSCLC

NCT05534113 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-09-14

No results posted yet for this study

Summary

This is a prospective, single-arm, open-label, interventional clinical study, aimed at exploring the efficacy and safety of sequential Envafolimab immunotherapy after patients with ctDNA EGFR mutation clearance and achieved stable radiographically deep esponse after first line treatment with Almonertinib in EGFR-Mutant, PD-LI positive non-small-cell lung cancer.

Conditions

Interventions

DRUG

Almonertinib Envafolimab

Subjects will receive Almonertinib treatment for 6-8 weeks after enrollment, and receive ctDNA detection and radiography assessment again. If the EGFR mutation is positive, according to the patient's condition and clinical actual situation, subjects will receive combination therapy scheme, follow-up once every 6 weeks. The treatment will continue until the disease progress assessed by radiography. If the EGFR mutation turns negative and stable radiographically deep response, stop Almonertinib treatment and receive the relevant assessment before immunotherapy and receive Envafolimab treatment，and follow-up once every 6 weeks. The treatment of Envafolimab will continue until the EGFR mutation is positive again or disease progress assessed by radiography.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Yong Qian Shu · Jiangsu Provincial People's Hospital

  • Wen Gao · Jiangsu Provincial People's Hospital

  • Pei Ma · Jiangsu Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-06-01
Completion
2025-06-01

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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 NCT05534113 on ClinicalTrials.gov