Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT
NCT06483347 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-07-03
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).
Conditions
- Lung Cancer
- Inoperable Disease
Interventions
- DRUG
-
ipilimumab+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.
Sponsors & Collaborators
-
Second Affiliated Hospital of Guangzhou Medical University
lead OTHER
Principal Investigators
-
Zhenfeng Zhang, MD, PhD · Second Affiliated Hospital of Guangzhou Medical University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-04
- Primary Completion
- 2028-12-30
- Completion
- 2033-12-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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