Trials / Not Yet Recruiting

Not Yet RecruitingNCT07405190

Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum/Pemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)

Status: Not Yet Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 46 (estimated)

Sponsor: Massachusetts General Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin/pemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are: * Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy shrink tumors in the clinical trial's patients? * Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients? * How many patients receiving ivonescimab alone or together with carboplatin/pemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin/pemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.

Detailed description

This is a phase II, open-label, two-cohort study designed to determine the efficacy of ivonescimab as monotherapy or in combination with carboplatin/pemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior standard-of-care therapies. Ivonescimab monotherapy will be evaluated in patients with advanced non-small cell lung cancer with actionable genomic alterations after prior standard-of-care targeted therapies and platinum/pemetrexed chemotherapy. Ivonescimab plus carboplatin/pemetrexed combination regimen will be evaluated in patients with advanced non-small cell lung cancer with non-epidermal growth factor receptor actionable genomic alterations after prior standard-of-care targeted therapies (and no prior chemotherapy). The U.S. Food and Drug Administration has not approved ivonescimab as a treatment for any disease. The U.S. Food and Drug Administration has approved carboplatin and pemetrexed as a treatment option for non-small cell lung cancer harboring actionable genomic alterations. Ivonescimab, also known as AK112 and SMT112 during development, is a specially engineered antibody that can attach to both PD-1 and VEGF-A. PD-1 is a protein found on immune cells that "turn off" the immune response. VEGF-A is a protein that helps tumors grow new blood vessels. By binding to both proteins, ivonescimab can reactivate immune cells so they can attack the tumor, block blood vessel growth that feeds the tumor, and reduce the tumor's ability to suppress the immune system, making it easier for immune cells to reach and fight the cancer. Carboplatin is a type of chemotherapy drug that contains a special form of platinum. The drug damages DNA inside cancer cells by creating links or bonds between different parts of the DNA that makes it harder for the cancer cells to grow and divide, eventually leading to cell death. Carboplatin works at any stage of the cell's life cycle, not just when the cell is dividing. Carboplatin is currently sold as Paraplatin. Pemetrexed is a type of chemotherapy drug that works by blocking specific substances, called folates, that cancer cells need to grow and multiply. Folates help cells make DNA and other important cell structures. By preventing folates from working, pemetrexed helps slow down or stop the growth of cancer cells. Pemetrexed is currently sold as Alimta. Patients will receive study treatment for up to 24 months as long as their disease does not progress, treatment does not cause worsening symptoms, they do not have unacceptable side effects, until they demonstrate an inability or unwillingness to receive the medication regimen and/or follow the document requirements, or they withdraw from the study. Patients will be followed for up to 2 years after the last patient is enrolled. It is expected that about 46 people will take part in this research study. Summit Therapeutics, Inc. is supporting this research study by providing the study drug, ivonescimab, and funding for the clinical trial activities.

Conditions

Interventions

Type	Name	Description
DRUG	Ivonescimab	Ivonescimab is a specially engineered antibody that can attach to both PD-1 and VEGF-A.
DRUG	carboplatin	Carboplatin is a type of chemotherapy drug that contains a special form of platinum.
DRUG	pemetrexed	Pemetrexed is a type of chemotherapy drug that works by blocking specific substances, called folates, that cancer cells need to grow and multiply.

Timeline

Start date: 2026-08-04
Primary completion: 2028-03-01
Completion: 2029-03-01
First posted: 2026-02-12
Last updated: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07405190. Inclusion in this directory is not an endorsement.