Study on Gocatamig and Infinatamab Deruxtecan for Treating Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07227597
This clinical trial is exploring a new treatment combination using Gocatamig and Infinatamab Deruxtecan (I-DXd) to see if it can help treat extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread to other parts of the body.
Patient Parameters
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Program Overview
Researchers are testing a new treatment for extensive-stage small cell lung cancer (ES-SCLC), which is a type of lung cancer that has spread beyond the lungs. The study is looking at whether combining two new medicines, Gocatamig and Infinatamab Deruxtecan (I-DXd), can help treat this cancer. Gocatamig is a type of immunotherapy that uses T-cells, a kind of white blood cell, to find and destroy cancer cells. I-DXd is a treatment that attaches to cancer cells and delivers medicine to kill them. The study will also see if these medicines can be used with standard treatments like chemotherapy and immunotherapy to improve outcomes.
Description
In the first part of the study, participants will be placed in one of two groups based on the doctor's decision. In the second part, participants will be placed in one group based on the doctor's decision and randomly assigned to one of three other groups.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC).
- For those receiving Gocatamig and I-DXd as maintenance treatment:
- Completed 3 to 4 cycles of chemotherapy with platinum and etoposide, along with an approved immunotherapy, as the first treatment for ES-SCLC within 6 weeks before joining the study.
- No signs of cancer progression on scans.
- No other previous treatments for ES-SCLC.
- Repeated treatment counts as a new line of therapy and leads to exclusion.
- For those receiving Gocatamig and I-DXd in different treatment phases, no prior treatment for ES-SCLC is allowed.
- Previous limited-stage small cell lung cancer is allowed if more than 6 months have passed since the last treatment and the cancer has progressed.
- Must provide a tumor sample from before treatment or a new biopsy from a tumor that hasn't been treated with radiation.
- Must have measurable disease as determined by scans, even if the tumor was previously treated with radiation, as long as it has grown since then.
Exclusion Criteria
- Have fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
- Have a history of lung diseases like interstitial lung disease or pneumonitis, or current lung issues that can't be ruled out by scans.
- Have severe lung problems due to other illnesses.
- Have a history of serious bleeding in the brain or spinal cord.
- Have active neurological conditions related to cancer.
- Have had recent heart surgeries or serious heart conditions like heart attacks or heart failure within 6 months before starting the study.
- Have other serious heart diseases as specified in the study.
- Have had a blood clot in an artery within 6 months before starting the study.
- Have chronic liver disease.
- Have had a tissue or organ transplant.
- Have a history of cancer spreading to the brain or spinal cord lining.
- Have HIV with a history of certain related diseases.
- Have received certain immunotherapy treatments before.
- Have had radiation therapy within 2 weeks before starting the study or have side effects from radiation that need steroids.
- Have another active cancer that has needed treatment in the past 3 years.
- Have an active autoimmune disease needing treatment in the past 2 years, except for replacement therapy.
- Have active cancer spread to the brain or spinal cord lining.
- Have had major surgery within 4 weeks or minor surgery within 2 weeks before starting the study, or need major surgery during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Medical Foundation ( Site 0124) | 95403 | Santa Rosa | California |
| Orlando Health Cancer Institute ( Site 0108) | 32806 | Orlando | Florida |
| Saint Elizabeth Medical Center Edgewood ( Site 0112) | 41017 | Edgewood | Kentucky |
| Washington University School of Medicine ( Site 0134) | 63110 | St Louis | Missouri |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) | 07601 | Hackensack | New Jersey |
| Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) | 97213 | Portland | Oregon |
| Avera Cancer Institute- Research ( Site 0104) | 57105 | Sioux Falls | South Dakota |
| The University of Tennessee Medical Center ( Site 0120) | 37920 | Knoxville | Tennessee |
| SCRI Oncology Partners ( Site 7000) | 37203 | Nashville | Tennessee |
| Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) | 77030 | Houston | Texas |
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