Study on the Safety and Effectiveness of Gocatamig and Ifinatamab Deruxtecan for Treating Relapsed or Resistant Extensive-Stage Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06780137
This clinical trial is exploring a new treatment using Gocatamig, an immunotherapy, and Ifinatamab Deruxtecan, a targeted drug, to see if they can help treat extensive-stage small cell lung cancer (SCLC) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
Researchers are testing a new treatment for people with extensive-stage small cell lung cancer (SCLC) that has come back or not responded to previous treatments. Gocatamig is a type of immunotherapy that helps the immune system find and destroy cancer cells. Ifinatamab Deruxtecan (I-DXd) is a drug that targets cancer cells and delivers treatment directly to them. The study aims to find out if these drugs are safe, well-tolerated, and effective in shrinking or eliminating the cancer.
Description
The study is divided into two parts. In Part 1, researchers will test the safety and effectiveness of Gocatamig and I-DXd when given every 2 or 3 weeks, based on doses from a previous study. In Part 2, the focus will be on the safety and tolerability of Gocatamig in Japanese participants.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of extensive-stage small cell lung cancer (SCLC) that has returned or not responded to at least one previous treatment, including platinum-based chemotherapy.
- Be able to provide a previous or new tissue sample for testing.
- If HIV-positive, have well-controlled HIV with antiretroviral therapy.
Exclusion Criteria
- Have fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
- Have a history of lung inflammation or disease that required steroids, or currently have or are suspected to have lung inflammation.
- Have severe lung problems due to other illnesses.
- Have a history of significant bleeding in the brain or spinal cord.
- Have an active or past immune deficiency, except for well-controlled HIV.
- Have had major heart or blood vessel surgery or significant heart disease within the last 6 months.
- Have other serious heart conditions as specified in the study.
- Have had a stroke or mini-stroke within the last 6 months.
- Have chronic liver disease or cirrhosis.
- Have an active serious infection needing treatment.
- Have had a tissue or organ transplant.
- Have a history of cancer spreading to the brain or spinal cord lining.
- Have had radiation therapy within 2 weeks before starting the study, or have side effects from radiation needing steroids.
- Are taking immunosuppressive medications, with some exceptions.
- Have another active cancer needing treatment within the last 3 years.
- Have untreated or symptomatic brain cancer spread.
- Have active viral hepatitis, unless the virus is undetectable after treatment.
- For Part 1 only: Have had lung radiation over 30 Gy within 6 months before starting the study.
- For Part 1 only: Have had abdominal radiation within 4 weeks before starting the study.
- For Part 1 only: Have had other cancer treatments within 2 weeks before starting the study.
- For Part 1 only: Have had antibody-based cancer therapy within 3 weeks before starting the study.
- For Part 1 only: Have taken chloroquine or hydroxychloroquine within 2 weeks before starting the study.
- For Part 1 only: Have significant corneal disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute ( Site 1105) | 02215 | Boston | Massachusetts |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) | 07601 | Hackensack | New Jersey |
| Sarah Cannon Research Institute ( Site 7001) | 37203 | Nashville | Tennessee |
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