NCT06618391

Local Injection and Systemic Therapy in the Treatment of NSCLC.

Envafolimab and Recombinant Human Endostatin and Recombinant Human Adenovirus Type 5 Intratumor Local Injection Combined With Systemic Therapy in Patients With Advanced NSCLC :a Prospective, Exploratory Phase II Clinical Study Tudy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC).

Detailed description

This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC). Patients with pathologically confirmed unresectable locally advanced/advanced NSCLC with atelectasis were screened and eligible subjects were randomized to receive local intratumoral injection of envolumab/Endostar/recombinant human adenovirus type 5 H101 combined with systemic therapy after signing informed consent.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Envafolimab	Envolimab :150 mg/time, intratumoral injection, at least 5 sites; Recombinant human endostatin： Q3W for 4-6 cycles，Maintenance therapy 210 mg ,CIV 72 hours ,administered as continuous intravenous pump, administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.
DRUG	Recombinant human endostatin	Recombinant human endostatin: 15mg/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.
DRUG	recombinant human adenovirus type 5	Recombinant Human Adenovirus Type 5: 1.0ml/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-03-02
• Completion: 2026-10-30
• First posted: 2024-10-01
• Last updated: 2024-10-01