Table of Contents
- Trial overview
- Who is being studied
- Treatments being tested
- What researchers measure
- What Phase 1 means
- Trial status and size
Trial overview
The available study is a clinical trial of GOCATAMIG in people with small cell lung cancer[1]. It is an interventional study, which means participants receive study treatment so researchers can observe the effects[1].
The trial is called MK-6070-002 and it is currently Authorised[1]. The study plans to include 242 participants[1].
Who is being studied
The trial is focused on people with small cell lung cancer[1]. The source data does not give more detailed rules for who can join, so only this target population can be confirmed from the trial record[1].
Treatments being tested
Researchers are testing GOCATAMIG in several ways[1].
GOCATAMIG with ifinatamab deruxtecan: Part 1 studies this combination and also compares different schedules, meaning different timing plans for treatment[1].
Ifinatamab deruxtecan alone: Part 1 also includes this treatment by itself every 2 weeks, so researchers can compare it with the combination approach[1].
GOCATAMIG alone: Part 2 looks at GOCATAMIG as a single treatment, which is called monotherapy[1].
GOCATAMIG with durvalumab: Part 3 studies this combination to see whether it can be given safely and tolerated well[1].
The interventions listed for the study include GOCATAMIG, ifinatamab deruxtecan, and durvalumab, all given by intravenous infusion, which means through a vein[1].
What researchers measure
The main goal of the trial is to learn about safety and tolerability[1]. Researchers are watching for adverse events, which are unwanted medical problems that happen during the study[1].
The study also measures dose-limiting toxicities, which are side effects serious enough to limit treatment, and whether participants stop study treatment because of an adverse event[1].
For Part 1, the trial measures objective response rate using RECIST 1.1, a standard system for checking tumor changes on scans[1]. In simple terms, this shows how many people have a tumor response, such as shrinkage, based on study rules[1].
What Phase 1 means
This study is in Phase 1[1]. Phase 1 trials are early studies that mainly ask whether a treatment can be given safely and how people tolerate it[1].
Because this is an early phase trial, the focus is not only on whether the treatment works, but also on whether the treatment plan can be given with an acceptable level of side effects[1].
Trial status and size
The trial status is Authorised[1]. The planned enrollment is 242 participants, which is the total number of people the study aims to include[1].
At this stage, the trial record shows a single study focused on small cell lung cancer, with several treatment parts that help researchers compare GOCATAMIG alone and in combination with other drugs[1].
