#1 Clinical Trials Search in Europe

Tusamitamab Ravtansine

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.

Table of Contents

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]

Trial ID Phase Condition studied Status Enrollment
2023-509115-84-00 Phase 2 NSQ NSCLC Completed 14

FAQ

  • What is being studied in the Tusamitamab Ravtansine trial? The trial is studying Tusamitamab Ravtansine in combination with pembrolizumab, and in another group with pembrolizumab plus platinum-based chemotherapy with or without pemetrexed. The main goals are to check safety, find the recommended dose, and measure antitumor activity.
  • Who can take part in this trial? The trial is for people with NSQ NSCLC, which means non-squamous non-small cell lung cancer. The source data does not give more details about other entry rules.
  • What phase is this clinical trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may help and how safe it is in a specific patient group.
  • What outcomes are the researchers measuring? The study measures dose-limiting toxicity during the first treatment cycle. It also measures objective response rate, which means how many patients have a noticeable shrinkage of their cancer.
  • Is this trial still open for enrollment? No. The trial is listed as completed, and the enrollment was 14 participants.

Ongoing Clinical Trials on Tusamitamab Ravtansine

Unfortunately, we did not find any clinical trials matching the selected criteria. Try changing the filter settings or broadening the search criteria to see more available research participation opportunities.

Glossary

  • NSQ NSCLC: A type of lung cancer called non-squamous non-small cell lung cancer. 'Non-squamous' describes the cancer cell type.
  • Phase 2: A trial stage that looks at early signs of benefit and continues safety testing in a specific group of patients.
  • Interventional study: A study where participants receive one or more treatments so researchers can see what happens.
  • Pembrolizumab: A treatment used in this trial as part of the study combinations.
  • Platinum-based chemotherapy: A group of cancer treatments that includes cisplatin and carboplatin in this trial.
  • Pemetrexed: A cancer drug used in one of the study combinations.
  • Dose-limiting toxicity: A side effect serious enough to limit how much of a study treatment can be given.
  • Objective response rate: The share of patients whose tumors shrink or disappear during the study.
  • Safety run-in: The first part of a study used to check tolerability and choose doses before the larger study part.
  • Recommended dose for expansion: The dose selected in the early part of the study to test further in more patients.

References