In short
Clinical trials are studying Tusamitamab Ravtansine in people with NSQ NSCLC, a type of non-squamous non-small cell lung cancer. The trial is looking at safety, the right dose, and how well the treatment works when combined with pembrolizumab and platinum-based chemotherapy, with or without pemetrexed.
Key points
- Tusamitamab Ravtansine is being studied in a Phase 2 trial for people with NSQ NSCLC, a type of non-squamous non-small cell lung cancer. The study tested Tusamitamab Ravtansine with pembrolizumab, and also with pembrolizumab plus platinum-based chemotherapy with or without pemetrexed. Researchers first looked at safety and dose selection, then at how well the treatment shrank tumors. The trial is completed and included 14 participants. The main measured outcomes were dose-limiting toxicity and objective response rate.
Trial overview
The study titled CARMEN-LC05 investigated Tusamitamab Ravtansine in people with NSQ NSCLC, which means non-squamous non-small cell lung cancer. It was an interventional trial, so participants received study treatments and researchers watched the results.
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.
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. The source says the safety run-in was used to assess tolerability and to find the recommended doses for the later expansion part.
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. The study also included participants treated at the recommended dose for expansion from the safety run-in part.
Who participated
The trial was designed for people with NSQ NSCLC. The source data does not list more detailed entry rules, such as age limits or previous treatments.
In total, the study enrolled 14 participants.
What was measured
The main safety outcome was the incidence of dose-limiting toxicity during Cycle 1, from C1D1 to C1D21. Dose-limiting toxicity means a side effect serious enough to affect how much treatment can be given.
For the expansion part, the main effectiveness outcome was objective response rate, or ORR. ORR shows how many participants had a measurable shrinkage of their cancer during the study.
Trial status and size
The trial status is listed as Completed. This means the study has finished collecting the planned data in the source record.
The enrollment was small, with 14 participants, so this study was mainly an early research step rather than a large confirmatory trial.