Amivantamab + TKI for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining amivantamab (a monoclonal antibody) with tyrosine kinase inhibitors (TKIs) can more effectively treat certain types of non-small cell lung cancer (NSCLC) that have become resistant to current TKI treatments. The focus is on patients with specific gene fusions (ALK, ROS1, or RET) that often stop responding to TKIs over time. Individuals with advanced NSCLC who have these gene fusions and have experienced disease progression despite TKI therapy might be suitable candidates for the trial. As a Phase 1, Phase 2 trial, it examines how the treatment works in people and measures its effectiveness in an initial, smaller group, offering a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires participants to have been on a TKI (a type of cancer medication) at the same dose for at least 8 weeks before enrolling, without any new progression or intolerance. The protocol does not specify if you need to stop other medications, but you should discuss your current medications with the study team to ensure they won't interfere with the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that amivantamab is approved for treating advanced non-small cell lung cancer (NSCLC) with specific mutations. This approval indicates it has undergone safety testing for these cases. Studies have found that most patients tolerate amivantamab well. While some side effects occur, they are usually manageable. Common side effects include skin rash and injection site reactions.
Amivantamab has also been tested in real-world situations, and its safety profile remains consistent. Researchers have not identified any new or unexpected safety issues. Although no treatment is without risk, available data suggest amivantamab is relatively safe for treating certain lung cancers. It is important to consult a healthcare provider to understand what this might mean for individual cases.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for advanced non-small cell lung cancer (NSCLC) with ALK, ROS1, and RET gene fusions, which typically involve targeted therapies like crizotinib, ceritinib, or alectinib, amivantamab offers a unique approach. This treatment is distinct because it is a bispecific antibody that targets both EGFR and MET pathways, potentially overcoming resistance seen with current therapies. Researchers are excited because this dual-targeting strategy could offer new hope for patients whose cancer has progressed on conventional tyrosine kinase inhibitors (TKIs), providing a novel mechanism to tackle treatment-resistant tumors.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research has shown that amivantamab, one of the treatments studied in this trial, may help treat non-small cell lung cancer (NSCLC) with certain genetic changes when used with tyrosine kinase inhibitors (TKIs). In past studies, patients with advanced NSCLC experienced better results when amivantamab was added to chemotherapy compared to chemotherapy alone. This combination targets specific pathways, ERBB and cMet, which help cancer cells survive despite TKI treatment. By blocking these pathways, the combination may prevent the cancer from becoming resistant. These findings suggest that using amivantamab with TKIs could improve outcomes for patients whose cancer has not responded to other treatments.46789
Who Is on the Research Team?
Erin Schenk, MD, PhD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
Adults with advanced NSCLC who have ALK, ROS1, or RET gene fusions and have seen their cancer progress after at least one TKI treatment. They must be currently on a stable dose of TKI for 3+ months, able to take oral meds, and have a life expectancy over 12 weeks. Excluded are those with certain prior treatments, active infections like HIV or hepatitis B/C, pregnant women, and anyone with severe allergies to study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Finding (Safety Lead-In)
To estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in adult participants with advanced NSCLC with ALK, ROS1, and RET gene fusions
Dose Expansion
To estimate the objective response rate (ORR) of amivantamab in combination with common TKIs used in ALK, ROS1, and RET advanced NSCLC progressing on TKIs
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Janssen Research & Development, LLC
Industry Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University