NCT05534113

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

Sequential Envafolimab Immunotherapy After Patients With ctDNA EGFR Mutation Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive Non-small-cell Lung Cancer：Efficacy and Safety Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study includes a screening period (not more than 28 days after the subject signs informed consent to before the first medication), treatment period (including Almonertinib treatment in 6-8 weeks after enrollment\\ctDNA testing and radiographically imaging assessment\\ctDNA guiding sequential Envafolimab immunotherapy) and follow-up period (including survival and safety) . Eligible subjects receive 110 mg of Almonertinib once a day for 6-8 consecutive weeks of treatment，and receive ctDNA testing and radiographically imaging assessment again. According to test results, there are two types: 1. EGFR mutation is positive, subjects subsequent treament is up to the investigator (continue to receive 110 mg of Almonertinib once a day or combination therapy regimen), follow up every 6 weeks. 2. EGFR mutation is negative and achieve stable radiographically deep response after 6-8 weeks treatment with Almonertinib, subjects will stop Almonertinib treatment，and receive sequential Envafolimab immunotherapy (ctDNA dynamic monitoring guided treatment，every 6 weeks test ctDNA once, if it is negative, subjects continue to receive Envafolimab immunotherapy until ctDNA EGFR turns positive; if ctDNA EGFR is positive, subjects stop Envafolimab immunotherapy and receive Almonertinib 110 mg once a day again until ctDNA EGFR turns negative). The treatment will continue until disease progression assessed by the investigator according to RECIST 1.1 criteria, or withdrawal or termination criteria are reached.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-09-09
• Last updated: 2022-09-14