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)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507687-38-00

Acronym

MK-3475-B98

Enrollment

Registered

2024-03-27

Start date

2021-08-23

Completion date

Unknown

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with extensive-stage small cell lung cancer

Brief summary

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs), Number of Participants Who Experience at Least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE), Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

Detailed description

Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

Interventions

DRUGLenvatinib

DRUGAPREPITANT

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUG-

DRUGMK-4830

DRUGMK-4280A

DRUGDEXAMETHASONE

DRUGRaludotatug Deruxtecan

DRUGMK-1308A

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs), Number of Participants Who Experience at Least One Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE), Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	—

Secondary

Measure	Time frame
Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	—

Countries

Austria, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026