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)
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)
🩺 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: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center ( Site 0152) — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 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,
📞 Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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- Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.