RecruitingPhase 2NCT06483347

Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT

Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and/or Bevacizumab Therapy as First Line for Inoperable Lung Cancer

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

90 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Inoperable Disease

Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two checkpoint inhibitor immunotherapy drugs — delivered directly into the tumor (intratumoral injection) — can work as a first-line treatment for people with inoperable lung cancer. Delivering the drugs directly into the tumor may boost the local immune response. **You may be eligible if...** - You are over 18 with lung cancer confirmed by biopsy or cytology - Your estimated survival is more than 3 months - You have adequate blood counts and organ function - You have at least one measurable tumor - You are willing to comply with study visits and tests **You may NOT be eligible if...** - You have previously participated in another clinical trial for this condition - You have severe liver problems (Child-Pugh class C) - You have active autoimmune disease or take immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab

This study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks.