Study on GSK5764227 for Treating Relapsed Small Cell Lung Cancer (SCLC)
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT07099898
This clinical trial is testing a new drug, Risvutatug rezetecan (Ris-Rez), to see if it can better treat relapsed small cell lung cancer (SCLC) compared to the standard treatment, topotecan. The study will evaluate if Ris-Rez can shrink or eliminate tumors and help patients live longer, while also assessing its safety and side effects.
Patient Parameters
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Program Overview
The purpose of this study is to test a new medication called Risvutatug rezetecan (Ris-Rez) for treating small cell lung cancer (SCLC) that has returned after initial treatment. Ris-Rez targets specific proteins on cancer cells to stop them from growing and spreading. Researchers want to see if Ris-Rez is more effective than the current standard treatment, topotecan, in reducing cancer size and improving patient survival. The study will also compare the safety and side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years old.
- Diagnosed with extensive-stage small cell lung cancer (ES-SCLC).
- Previously treated with a platinum-based therapy and a PD-(L)1 inhibitor, with a break from chemotherapy of more than 30 days, and the cancer has progressed.
- At least one measurable tumor as determined by the study doctor.
- Able to provide informed consent and follow study requirements.
- Good organ function and overall health status (ECOG score of 0 or 1).
Exclusion Criteria
- Diagnosed with complex or transformed small cell lung cancer.
- Initially diagnosed with limited-stage small cell lung cancer.
- Previously treated with certain types of cancer drugs, including those targeting B7-H3.
- Allergic to components of the study drugs or have other allergies that prevent participation.
- Have severe or uncontrolled heart problems.
- Have significant bleeding issues within the last month.
- Have active infections requiring treatment or known HIV.
- Have untreated or worsening brain metastases or certain types of brain or spinal cord cancer spread.
- Have a history of lung disease or conditions like pneumonitis requiring high-dose steroids.
- Have significant lung or breathing problems, such as uncontrolled asthma or COPD.
- Have active Hepatitis B or C infections.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 90027 | Los Angeles | California |
| GSK Investigational Site | 27893 | Wilson | North Carolina |
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