Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC

Sponsor
Swiss Cancer Institute
Study ID
NCT07158489
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • NSCLC
  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine + Ivonescimab — DRUG
    The trial combines two Investigational Medicinal Products (IMPs): * Gemcitabine, either alone or in combination regimens, is the standard of care (SoC) for several solid tumors, such as advanced or metastatic non-small cell lung cancer (mNSCLC). * Ivonescimab is developed for cancer immunotherapy. Ivonescimab binds to human vascular endothelial growth factor (VEGF) which is involved in tumor angiogenesis, and to human programmed cell death 1 (PD-1) that is a cell surface receptor expressed primarily on activated T cells and acts to inhibit their activation.

Study Details

This Phase II clinical trial (investigates the efficacy of combining gemcitabine, a chemotherapy agent, with ivonescimab, a bispecific PD-1/VEGF antibody, in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression following chemoimmunotherapy (CIT). Lung cancer remains the leading cause of cancer-related death globally, and treatment options after CIT failure are limited. Gemcitabine has demonstrated immunostimulatory properties, including enhanced T-cell infiltration and reduced immunosuppressive cell populations, which may synergize with immune checkpoint inhibitors. Ivonescimab targets both PD-1 and VEGF pathways, potentially enhancing antitumor immune responses and inhibiting tumor angiogenesis. The trial aims to evaluate the objective response rate (ORR) according to RECIST v1.1 criteria. The combination therapy is expected to offer a novel and effective treatment strategy for patients with relapsed NSCLC, addressing a significant unmet medical need.

Key Dates

First listed
Sep 5, 2025
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine + Ivonescimab in Advanced NSCLC Resistant to Immunotherapy

Primary Outcome Measure

Objective response rate (ORR) according to RECIST v1.1 [ Time Frame: At the end of trial treatment, up to 2 years from registration. ]

Central Contacts

Find similar trials

Nationwide
Lung cancer trialsOncology trialsLung oncology trialsLung disease trials

Related Studies