117 Participants NeededMy employer runs this trial

Sacituzumab Govitecan + Ivonescimab for Non-Small Cell Lung Cancer

Recruiting at 40 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: SWOG Cancer Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.

Who Is on the Research Team?

SC

Susan C Scott

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurrent non-small cell lung cancer that has specific gene changes (ALK, EGFR, HER2, MET, NTRK, RET, ROS1) and whose cancer got worse after targeted therapy and chemotherapy. Participants must have measurable disease on scans and be in stable condition if they had brain involvement.

Inclusion Criteria

I have had three or fewer prior chemotherapy treatments for my lung cancer.
I have not received TROP2-targeted or sacituzumab govitecan treatments.
I have no ongoing nerve problems from brain or spine tumors and am stable after treatment.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Ivonescimab
  • Sacituzumab Govitecan

Trial Overview

The study compares three treatments: sacituzumab govitecan alone, ivonescimab alone, or both drugs together. Patients are randomly assigned to one of these groups to see which works best at shrinking tumors in this type of lung cancer.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Arm 3 (ivonescimab)Experimental Treatment4 Interventions
Group II: Arm 2 (sacituzumab govitecan)Experimental Treatment4 Interventions
Group III: Arm 1 (ivonescimab, sacituzumab govitecan)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Recruited
267,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+