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Local Injection and Systemic Therapy in the Treatment of NSCLC.

NCT06618391 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-10-01

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Hongbo Wu, M.D. · Henan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2026-03-02
Completion
2026-10-30

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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 NCT06618391 on ClinicalTrials.gov