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

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT06483347
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Apr 4, 2024
Status verified
Jun 2024
Primary completion
Dec 30, 2028
Completion
Dec 30, 2033

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IT injection of double ICI
    Arm 1: intra-tumor injection of double ICIs only.
  • Experimental: IT injection of double ICI and chemodrug
    Arm 2: intra-tumor injection of double ICIs and a chemodrug.
  • Experimental: IT injection of double ICI and chemodrug plus bevacizumab
    Arm 3: intra-tumor injection of double ICIs, a chemodrug, and bevacizumab.

Primary Outcome Measure

Safety of IT delivery of drugs combination treatment [ Time Frame: 5 years ]

Central Contacts

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