OncoMatch/Clinical Trials/NCT04938817
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)
Is NCT04938817 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for small cell lung carcinoma.
Treatment: coformulation pembrolizumab/quavonlimab · lenvatinib · MK-4830 · coformulation favezelimab/pembrolizumab · R-DXd — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IV (T ANY, N ANY, M1A/B/C) (AJCC 8th Edition)
Metastatic disease required
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy in combination with platinum-based systemic therapy — first-line
Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered as part of first-line platinum-based systemic therapy for ES-SCLC
Cannot have received: systemic anticancer therapy including investigational agents
Exception: within 4 weeks before start of study treatment
Has received prior systemic anticancer therapy including investigational agents within 4 weeks before start of study treatment
Cannot have received: radiotherapy
Exception: within 2 weeks of start of study treatment
Has received prior radiotherapy within 2 weeks of start of study treatment
Cannot have received: lung radiation therapy >30 Gray
Exception: within 6 months before the first dose of study treatment
Has received lung radiation therapy >30 Gray (Gy) within 6 months before the first dose of study treatment
Cannot have received: receptor tyrosine kinase (RTK) inhibitor
Has received prior therapy with a receptor tyrosine kinase (RTK) inhibitor
Cannot have received: anti-CTLA-4 therapy
Has received prior therapy with ... anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
Cannot have received: anti-ILT4 therapy
Has received prior therapy with ... anti-immunoglobulin-like transcript (ILT)-4
Cannot have received: anti-LAG-3 therapy
Has received prior therapy with ... anti-lymphocyte-activation gene 3 (LAG-3) agents
Cannot have received: anti-PD-1/L1 therapy (permanently discontinued due to treatment-related adverse event)
Has received prior therapy with an anti-PD-1/L1 agent and was permanently discontinued from that treatment due to a treatment-related adverse event
Cannot have received: CDH6-targeted agent
Received prior treatment with a CDH6-targeted agent
Cannot have received: ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (trastuzumab deruxtecan, datopotamab deruxtecan)
Received prior treatment with ... an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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