Amivantamab for Lung Cancer
(CHRYSALIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment called Amivantamab, both alone and in combination with other drugs, for people with advanced non-small cell lung cancer (NSCLC). Researchers aim to determine the best dose and assess its effectiveness in controlling the cancer. The trial includes different treatment groups: some will receive Amivantamab alone, others with lazertinib (a targeted therapy), and others with standard chemotherapy drugs. People with advanced NSCLC that has spread or cannot be surgically removed, and who have tried other treatments without success, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that participants should not have had chemotherapy, targeted cancer therapy, or immunotherapy within 2 weeks or 4 half-lives before starting the study drug. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that amivantamab holds promise as a treatment for certain types of lung cancer. It is already approved for use in non-small cell lung cancers (NSCLCs) with specific mutations, indicating it has been tested and deemed safe for those cases.
Research on the combination of amivantamab and lazertinib shows it is generally well-tolerated. Most side effects are mild, though some patients may experience more serious reactions. This combination has proven effective, and safety data suggests it is manageable for most patients.
While these treatments appear promising, discussing potential risks with a healthcare provider before joining a trial is important.12345Why are researchers excited about this trial's treatments?
Amivantamab is unique because it acts directly on specific mutations in lung cancer cells, targeting the EGFR and MET pathways, which are often responsible for tumor growth. Unlike standard treatments like chemotherapy that target all rapidly dividing cells, Amivantamab specifically homes in on cancer-driving mutations, potentially leading to fewer side effects. Additionally, when combined with Lazertinib, a targeted therapy, it may enhance effectiveness by blocking multiple pathways that cancer cells use to grow and survive. This dual-target approach is what makes researchers particularly excited, offering hope for more precise and effective treatment options for lung cancer patients.
What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?
Research has shown that amivantamab effectively treats advanced non-small cell lung cancer (NSCLC) with specific genetic changes. One study found that patients receiving amivantamab lived without cancer progression for an average of 8.3 months and had an overall survival of 22.8 months. Additionally, real-world evidence supports its effectiveness, with about 35% of patients who had undergone multiple previous treatments responding to it.
In this trial, participants may receive amivantamab as monotherapy or combined with lazertinib. Studies have found that combining amivantamab with lazertinib works better than lazertinib alone for treating NSCLC with EGFR mutations. This combination can help prevent cancer from becoming resistant to treatment in some patients. Together, these treatments offer promising options for managing certain types of lung cancer.12467Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer (NSCLC). Participants must have specific types of NSCLC, be eligible for certain chemotherapy treatments, and may have progressed after standard care or refused other options. They should not have had recent cancer treatment or major surgery and must be in good physical condition without serious illnesses that could affect study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Amivantamab monotherapy or in combination with lazertinib or chemotherapy in 21 or 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Post-treatment Follow-up
Participants are followed for survival and safety monitoring until the end of the study
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Carboplatin
- Lazertinib
- Pemetrexed
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?
Janssen Research & Development, LLC
Lead 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