Amivantamab + Lazertinib for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation. Both drugs work to target cancer cells with an EGFR mutation, and this targeting action could stop or slow the growth of cancer cells. The researchers are doing this study to find out how well amivantamab and lazertinib work against metastatic NSCLC with an EGFR mutation.
Do I need to stop my current medications for the trial?
The trial requires that you stop taking any EGFR TKI or other oral treatments at least 3 days before starting the study drugs. Additionally, you must not have had systemic chemotherapy within 2 weeks of starting the trial. If you are taking medications or supplements that are potent CYP3A4/5 inducers, you will need to stop them for an appropriate washout period before enrolling.
Is the combination of Amivantamab and Lazertinib safe for humans?
The combination of Amivantamab and Lazertinib has been studied in clinical trials for lung cancer, and the safety profile was generally consistent with previous experiences of each drug alone. In one study, 4% of patients experienced severe side effects, but no new safety concerns were identified.12345
How is the drug combination of Amivantamab and Lazertinib unique for lung cancer treatment?
The combination of Amivantamab and Lazertinib is unique because it targets specific mutations in non-small cell lung cancer (NSCLC) that have become resistant to standard treatments like osimertinib. Amivantamab is a bispecific antibody that targets both EGFR and MET mutations, while Lazertinib is a third-generation EGFR inhibitor, making this combination effective for patients who have relapsed after other therapies.23456
What data supports the effectiveness of the drug combination Amivantamab and Lazertinib for lung cancer?
Research shows that the combination of Amivantamab and Lazertinib is effective in treating non-small cell lung cancer, especially in patients who have relapsed after using another drug called osimertinib. In one study, 36% of patients responded to this combination, and it helped control the disease for about 11 months on average.23456
Who Is on the Research Team?
Helena Yu, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread, and have specific EGFR mutations. They must have tried certain treatments like osimertinib without success. Participants need to be able to take oral meds, not be pregnant or breastfeeding, use effective birth control, and have good organ function. People with HIV, recent surgeries or radiotherapy, unresolved lung conditions like ILD, uncontrolled illnesses or other cancers aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab and lazertinib for metastatic NSCLC with EGFR mutation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Lazertinib
Amivantamab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University