MK-3475-B98
Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy
Active, Not Recruiting
Trial Purpose
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.
View more trial information on ClinicalTrials.gov
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National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. | NCT04938817 |
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MSD Protocol ID |
MK-3475-B98 |
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Conditions |
Small Cell Lung Carcinoma |
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Age Range |
18+ |
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SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. | ALL |
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Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. | 1, 2 |
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Start Date End Date |
2021-08-19 2029-12-10 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Small Cell Lung Carcinoma
Trial Phase 1
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial Locations
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What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
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