Study on Safety and Effectiveness of New Treatments Alone or with Pembrolizumab for Extensive-Stage Small Cell Lung Cancer Needing Second-Line Therapy
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04938817
This clinical trial is testing new treatments, either alone or combined with pembrolizumab, for patients with extensive-stage small cell lung cancer (ES-SCLC) that needs a second round of treatment. The study will first check the safety of these treatments before evaluating how well they work.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring new treatments for patients with extensive-stage small cell lung cancer (ES-SCLC) that has not responded to initial treatments. The trial will first assess the safety of these treatments, either used alone or with pembrolizumab, before moving on to evaluate their effectiveness. The study does not involve testing any specific hypotheses.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with extensive-stage small cell lung cancer (ES-SCLC) needing second-line treatment.
- Cancer has progressed after initial treatment with a PD-1/PD-L1 inhibitor as part of first-line therapy.
- Cancer is classified as Stage IV according to specific medical guidelines.
- Received one prior line of systemic therapy for small cell lung cancer.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Cancer must be measurable by standard criteria.
- Must provide a tumor tissue sample for analysis.
- Good overall health with an ECOG performance status of 0 to 1.
- Hepatitis B positive participants must have undetectable viral load after antiviral therapy.
- Hepatitis C positive participants must have undetectable viral load.
- Expected to live more than 3 months.
- Male participants must use contraception or abstain from intercourse during treatment and for a specified time after.
- Female participants must not be pregnant or breastfeeding and must use contraception or abstain from intercourse during and after treatment.
- Blood pressure must be controlled to specified levels.
- Participants capable of producing sperm must agree to use contraception and not donate sperm during and after treatment.
Exclusion Criteria
- Received any cancer treatment or investigational drugs within 4 weeks before starting the study.
- Received radiation therapy within 2 weeks before starting the study.
- Received high-dose lung radiation within 6 months before starting the study.
- Received a live vaccine within 30 days before starting the study.
- Have another progressing cancer or one that required treatment in the past 3 years.
- Have active brain metastases or cancer in the brain lining unless stable and treated.
- Have severe allergic reactions to study treatments.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have lung disease requiring steroids or current lung disease.
- Have an active infection needing treatment.
- Had major surgery within 3 weeks before starting the study.
- Have significant heart disease or recent major heart events.
- Have active bleeding or recent major bleeding events.
- Have digestive issues affecting medication absorption.
- Have a history of inflammatory bowel disease or gastrointestinal perforation.
- Have a history of neurologic paraneoplastic syndrome.
- Have received certain prior cancer treatments or investigational drugs recently.
- Have significant fluid buildup in the body.
- Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
- Have HIV or active hepatitis B or C.
- Have progressive disease after initial chemotherapy with PD-1/L1 inhibitor.
- Have had a tissue or organ transplant.
- Have received certain prior treatments specific to Arm E of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0152) | 85234 | Gilbert | Arizona |
| Northside Hospital-Northside Hospital Oncology Network ( Site 0156) | 30342 | Atlanta | Georgia |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0180) | 46845 | Fort Wayne | Indiana |
| Baptist Health Lexington-Research ( Site 0158) | 40503 | Lexington | Kentucky |
| University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157) | 40536 | Lexington | Kentucky |
| MFSMC-HJWCI-Oncology Research ( Site 0178) | 21237 | Baltimore | Maryland |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172) | 68130 | Omaha | Nebraska |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179) | 68130 | Omaha | Nebraska |
| Cleveland Clinic-Taussig Cancer Center ( Site 0166) | 44195 | Cleveland | Ohio |
| UPMC Hillman Cancer Center ( Site 0177) | 15232 | Pittsburgh | Pennsylvania |
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