Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (NCT04938817)
🩺 Plain-English Summary (8th-Grade Level)
This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (39 items).
Location: Banner MD Anderson Cancer Center ( Site 0152) — Gilbert, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: The main exclusion criteria include but are not limited to the following:
- Arms A-E:
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before start of study treatment
- Has received prior radiotherapy within 2 weeks of start of study treatment
- Has received lung radiation therapy \>30 Gray (Gy) within 6 months before the first dose of study treatment
- Has received a live or live attenuated vaccine within 30 days before the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following: completed treatment (e.g., whole brain radiation treatment, stereotactic radiosurgery, or equivalent) ≥14 days before the first dose of study intervention; have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging (using the same modality) performed ≥4 weeks after pretreatment brain imaging; and are neurologically stable without the need for steroids for ≥7 days before the first dose of study intervention as per local site assessment. Participants with untreated brain metastases will be allowed if they are asymptomatic, the investigator determines there is no immediate CNS-specific treatment required, there is no significant surrounding edema, and the brain metastases are of 5 millimeter (mm) or less in size and 3 or less in number.
- Has a history of severe hypersensitivity reaction (≥Grade 3) to any study treatment and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
- Has an active infection requiring systemic therapy
- Arms A-D:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (48 Sites)
- Banner MD Anderson Cancer Center ( Site 0152) — Gilbert, Arizona
- Northside Hospital-Northside Hospital Oncology Network ( Site 0156) — Atlanta, Georgia
- Parkview Research Center at Parkview Regional Medical Center ( Site 0180) — Fort Wayne, Indiana
- Baptist Health Lexington-Research ( Site 0158) — Lexington, Kentucky
- University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157) — Lexington, Kentucky
- MFSMC-HJWCI-Oncology Research ( Site 0178) — Baltimore, Maryland
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172) — Omaha, Nebraska
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179) — Omaha, Nebraska
- Cleveland Clinic-Taussig Cancer Center ( Site 0166) — Cleveland, Ohio
- UPMC Hillman Cancer Center ( Site 0177) — Pittsburgh, Pennsylvania
- St Francis Cancer Center-Research Office ( Site 0167) — Greenville, South Carolina
- Virginia Cancer Institute ( Site 0169) — Richmond, Virginia
- Westmead Hospital-Department of Medical Oncology ( Site 4004) — Westmead, New South Wales
- The Prince Charles Hospital-Oncology Clinical Trials ( Site 4003) — Brisbane, Queensland
- Monash Health-Oncology Research ( Site 4005) — Clayton, Victoria
- Hollywood Private Hospital-Medical Oncology ( Site 4001) — Perth, Western Australia
- Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 3101) — Vienna,
- Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 3100) — Vienna,
- Cross Cancer Institute ( Site 3004) — Edmonton, Alberta
- Princess Margaret Cancer Centre ( Site 3003) — Toronto, Ontario
- St. Marys Hospital Center ( Site 3000) — Montreal, Quebec
- Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 3800) — Szolnok, Jász-Nagykun-Szolnok
- Rambam Health Care Campus-Oncology ( Site 3600) — Haifa,
- Shaare Zedek Medical Center-Oncology ( Site 3602) — Jerusalem,
- Meir Medical Center. ( Site 3601) — Kfar Saba,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.