Study Comparing Acasunlimab and Pembrolizumab with Standard Chemotherapy for Advanced Non-Small Cell Lung Cancer
Sponsor: Genmab
ClinicalTrials ID:NCT06635824
This clinical trial is testing whether a combination of two drugs, acasunlimab and pembrolizumab, is more effective than the standard chemotherapy drug, docetaxel, for treating patients with advanced non-small cell lung cancer (NSCLC) that has spread and is PD-L1 positive.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if a new combination of drugs, acasunlimab and pembrolizumab, can better treat advanced non-small cell lung cancer (NSCLC) compared to the standard chemotherapy drug, docetaxel. This trial is for patients whose cancer has spread and who have already been treated with certain other cancer therapies. The study will also look at how these treatments affect patients' quality of life.
Description
This trial aims to compare the effectiveness and safety of a new drug combination, acasunlimab (also known as GEN1046 or DuoBody® PDL1x4-1BB) and pembrolizumab (KEYTRUDA®), against the standard chemotherapy drug, docetaxel, in treating advanced non-small cell lung cancer (NSCLC). Participants will be randomly assigned to receive either the new drug combination or docetaxel. The study will also assess participants' quality of life using standard measurement tools.
To participate, patients must have:
- Lung cancer that has spread to other parts of the body.
- Tumors that test positive for the PD-L1 protein, which may indicate a better response to the treatment.
- Previously received treatment with a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy, either together or one after the other.
Participants will be placed in one of two treatment groups:
- Acasunlimab (100 mg) and pembrolizumab (400 mg) every 6 weeks.
- Docetaxel (75 mg/m²) every 3 weeks.
The trial may last up to 5 years for each participant, including:
- An optional pre-screening period of up to 56 days.
- A screening period of 28 days.
- Up to 2 years of treatment.
- A 90-day follow-up period after treatment.
- Additional follow-up after treatment ends.
Eligibility Criteria
Inclusion Criteria
- Have advanced non-small cell lung cancer (NSCLC) that has spread (stage IV).
- Have previously been treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy, either together or one after the other.
- Have tumors that are PD-L1 positive (at least 1% of tumor cells).
- Have measurable cancer according to specific medical criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
- Have adequate organ and bone marrow function based on recent lab tests.
Exclusion Criteria
- Have certain genetic mutations that can be targeted by other specific treatments, unless those treatments are not available.
- Have unstable or symptomatic cancer that has spread to the brain or spinal cord.
- Have previously been treated with docetaxel for NSCLC.
- Have received certain types of immunotherapy or cancer vaccines before.
- Have been treated with another cancer drug within 28 days before starting the trial treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ocala Oncology Center P.L. | 34474 | Ocala | Florida |
| Norton Cancer Institute | 40202 | Louisville | Kentucky |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Oncology Hematology West | 68124 | Omaha | Nebraska |
| Clinical Research Alliance | 11590 | Westbury | New York |
| Avera Cancer Institute | 57105 | Sioux Falls | South Dakota |
| University of Tennessee Medical Center Cancer Institute | 37920 | Knoxville | Tennessee |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.