Bemarituzumab Combination Therapy for Squamous Cell Lung Cancer
(FORTITUDE-201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests bemarituzumab, a cancer treatment, alone or with other therapies. It aims to check its safety in cancer patients and find the best dose. Bemarituzumab works by attaching to cancer cells and blocking their growth.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Bemarituzumab combination therapy safe for humans?
Research shows that treatments like pembrolizumab (KEYTRUDA) and nanoparticle albumin-bound paclitaxel (Abraxane) have been studied for safety in lung cancer patients. These studies found that the treatments generally have an acceptable safety profile, meaning they are considered safe for use in humans, although they can have side effects like any medication.12345
What makes the Bemarituzumab combination therapy unique for squamous cell lung cancer?
The Bemarituzumab combination therapy is unique because it includes nab-paclitaxel, an albumin-bound form of paclitaxel, which improves drug concentration in tumors and has shown better response rates in squamous cell lung cancer compared to traditional solvent-based paclitaxel. This combination also includes pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, offering a novel approach by combining chemotherapy with immunotherapy.678910
What data supports the effectiveness of the drug Bemarituzumab Combination Therapy for Squamous Cell Lung Cancer?
Research shows that albumin-bound paclitaxel (nab-paclitaxel), a component of the combination therapy, has shown promising results in improving outcomes for patients with advanced non-small-cell lung cancer (NSCLC), which is a similar type of lung cancer. Studies have demonstrated its effectiveness and safety when used with carboplatin, another component of the therapy.5891011
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults with a specific lung cancer type (SqNSCLC) that can't be removed by surgery or has spread, and shows high levels of FGFR2b protein. Participants must have tried at least one systemic therapy before, unless they're in Part 4 where no prior treatment for advanced disease is allowed. They need good organ function and an ECOG status of 0 or 1, meaning they are fully active or restricted in physically strenuous activity but can do light work.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bemarituzumab monotherapy or in combination with other anti-cancer therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for survival and disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Bemarituzumab
- Carboplatin
- Docetaxel
- Nab-paclitaxel
- Paclitaxel
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London