BridgeMD
Compares treatment options for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Official title Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06801834
What this study is testing
What is Sacituzumab Govitecan (SG)?
Sacituzumab Govitecan (SG) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive stage small cell lung cancer (es-sclc).
Also referred to as Trodelvy®, GS-0132.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of SCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
- Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment)...
- Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of...
You likely can't join if
- Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \<...
- Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received...
- Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions...
See the full eligibility criteria
- Histologically confirmed diagnosis of SCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
- Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein...
- Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days...
- If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the...
- If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab...
- Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \< 30 days (independent of the immunotherapy maintenance).
- Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.
- Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate...
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Anaheim, California, United States
- Miami, Florida, United States
- Hinsdale, Illinois, United States
- Springfield, Illinois, United States
- Fort Wayne, Indiana, United States
- Muncie, Indiana, United States
- Dyer, Kentucky, United States
- Morehead, Kentucky, United States
- Scarborough, Maine, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- Sandusky, Ohio, United States
- Toledo, Ohio, United States
- Easton, Pennsylvania, United States
- Abilene, Texas, United States
- Houston, Texas, United States
- New Braunfels, Texas, United States
- Tyler, Texas, United States
- West Salem, Wisconsin, United States
+ 153 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hot Springs, Arkansas, United States; Anaheim, California, United States; Miami, Florida, United States; Hinsdale, Illinois, United States; Springfield, Illinois, United States; Fort Wayne, Indiana, United States and 167 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.