Table of Contents
- Trial overview
- Study design and treatment groups
- Who participated
- What was measured
- Trial status and size
Trial overview
The study titled CARMEN-LC05 investigated Tusamitamab Ravtansine in people with NSQ NSCLC, which means non-squamous non-small cell lung cancer.[1] It was an interventional trial, so participants received study treatments and researchers watched the results.[1]
This was a Phase 2 trial, which usually means the researchers were checking early signs of benefit while also continuing safety testing in a defined patient group.[1]
Study design and treatment groups
The safety run-in part studied Tusamitamab Ravtansine with pembrolizumab, and another combination of Tusamitamab Ravtansine with pembrolizumab plus platinum-based chemotherapy with or without pemetrexed.[1] The source says the safety run-in was used to assess tolerability and to find the recommended doses for the later expansion part.[1]
The expansion part was planned to assess antitumor activity, which means how well the treatment may work against the cancer, at several dose levels if needed.[1] The study also included participants treated at the recommended dose for expansion from the safety run-in part.[1]
Who participated
The trial was designed for people with NSQ NSCLC.[1] The source data does not list more detailed entry rules, such as age limits or previous treatments.[1]
In total, the study enrolled 14 participants.[1]
What was measured
The main safety outcome was the incidence of dose-limiting toxicity during Cycle 1, from C1D1 to C1D21.[1] Dose-limiting toxicity means a side effect serious enough to affect how much treatment can be given.[1]
For the expansion part, the main effectiveness outcome was objective response rate, or ORR.[1] ORR shows how many participants had a measurable shrinkage of their cancer during the study.[1]
Trial status and size
The trial status is listed as Completed.[1] This means the study has finished collecting the planned data in the source record.[1]
The enrollment was small, with 14 participants, so this study was mainly an early research step rather than a large confirmatory trial.[1]
