Amivantamab + Cetrelimab for Non-Small Cell Lung Cancer
(PolyDamas Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to determine the optimal dose of two drugs, amivantamab (a monoclonal antibody) and cetrelimab (an experimental treatment), for treating non-small cell lung cancer (NSCLC). The first phase identifies the best dose, while the second phase evaluates the combination's effectiveness against tumors. Suitable candidates for this trial include those with advanced NSCLC, particularly if their cancer has specific genetic features, such as EGFR mutations, or has progressed despite other treatments. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must complete any antibiotics at least one week before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of amivantamab and cetrelimab is under evaluation for safety in treating non-small cell lung cancer. Early results from other studies suggest these treatments are generally well-tolerated, though researchers continue to monitor for side effects.
In past research, amivantamab helped shrink tumors in many patients, which is encouraging. However, some patients experienced side effects, as with many treatments. Researchers are carefully monitoring these to find the right dose that balances effectiveness and safety.
Cetrelimab is often used with other treatments and is now under study to assess its effectiveness with amivantamab. While specific side effect information for this combination isn't detailed yet, the trial phase indicates active monitoring of patient responses to these drugs together.
Overall, the trials aim to ensure that the treatment's benefits outweigh any potential risks. Participants receive close monitoring to manage any side effects that may occur.12345Why are researchers excited about this trial's treatments?
Researchers are excited about amivantamab combined with cetrelimab because they bring a new approach to treating non-small cell lung cancer (NSCLC). Unlike the current standard treatments, which often target tumor growth directly with chemotherapy or target specific mutations with drugs like EGFR inhibitors, amivantamab is a bispecific antibody that blocks both EGFR and MET pathways, which are involved in cancer cell growth. Cetrelimab, on the other hand, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-1 pathway. This combination aims to tackle cancer from two angles: disrupting cancer cell signals and enhancing the immune response, offering hope for more effective outcomes in NSCLC treatment.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that combining the drugs amivantamab and cetrelimab may help treat non-small cell lung cancer (NSCLC). In this trial, participants will receive both drugs to evaluate their combined effectiveness. Previous studies found that amivantamab shrank tumors in 82% of patients, indicating a strong response. Cetrelimab, when used with other treatments, aids the immune system in fighting cancer. This trial tests whether the combination can help patients live longer without chemotherapy. Although more research is needed, early results are promising, especially for those with certain genetic markers like EGFR mutations.12345
Who 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 that has worsened after treatment with a specific type of medication called EGFR TKI and chemotherapy. Participants must be in good physical condition, have at least one measurable tumor not treated by radiation, and their cancer must have certain genetic changes known as EGFR exon19del or L858R mutations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Combination Dose Selection
Participants receive amivantamab low or high dose IV infusion based on body weight, with doses escalated or de-escalated based on dose limiting toxicities
Phase 2: Dose Expansion
Participants receive amivantamab in combination with cetrelimab at the RP2CD until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Cetrelimab
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