Amivantamab for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+98 other locations
Overseen ByShirish Gadgeel
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: SWOG Cancer Research Network
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.
What data supports the effectiveness of the drug Amivantamab for treating non-small cell lung cancer?
Amivantamab has been shown to be effective for patients with advanced non-small cell lung cancer (NSCLC) that have a specific mutation called EGFR Exon 20 insertion, especially after other treatments like platinum-based chemotherapy have failed. It has been approved for use in the USA and has demonstrated antitumor activity in combination with chemotherapy.
12356How is the drug Amivantamab unique for treating non-small cell lung cancer?
Amivantamab is unique because it is a bispecific antibody that targets both EGFR and MET proteins, specifically designed for non-small cell lung cancer with EGFR Exon 20 insertion mutations, especially after other treatments like platinum-based chemotherapy have failed.
12356Is amivantamab safe for humans?
Amivantamab has been approved for use in certain lung cancer patients, but it can cause side effects like infusion-related reactions, rash, and nausea. It's important to discuss potential risks with your doctor.
12346Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you must not have received any systemic therapy, like chemotherapy or immunotherapy, within 21 days before joining the study, and you cannot receive any other cancer treatments while participating.
Eligibility Criteria
This trial is for adults with advanced non-small cell lung cancer that has extra copies of the MET gene. They must have measurable disease, no other actionable cancer mutations, and should have tried at least one systemic treatment before. Participants need a recent CT or MRI scan and stable brain metastases if present.Inclusion Criteria
My condition worsened after my last treatment.
I do not have any other cancer that could affect this treatment's safety or results.
My current physical health allows me to perform daily activities.
I do not have high blood pressure that requires treatment.
I do not have any current infections.
I do not have any current bleeding disorders.
My disease can be measured on scans taken recently.
I do not need constant oxygen support.
My cancer does not have any known treatable gene changes.
I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.
I have never been treated with MET tyrosine kinase inhibitors for any cancer.
My NSCLC has MET amplification confirmed by a specific tissue test.
I am not planning to receive any other cancer treatments like chemotherapy or immunotherapy.
I do not have any active liver infections.
I do not have any eye conditions.
I do not have any specific lung conditions.
Participant Groups
The trial tests amivantamab-vmjw's effectiveness in treating lung cancer with MET amplification. It involves imaging tests like MRI and CT scans to monitor the disease, as well as collecting biospecimens to understand how the drug works.
1Treatment groups
Experimental Treatment
Group I: Treatment (amivantamab)Experimental Treatment4 Interventions
Patients receive amivantamab SC on days 1, 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial.
Amivantamab-vmjw is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Rybrevant for:
- 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 whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor
🇪🇺 Approved in European Union as Rybrevant for:
- Non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sutter Auburn Faith HospitalAuburn, CA
Memorial Medical CenterModesto, CA
Palo Alto Medical Foundation Health CarePalo Alto, CA
Sutter Roseville Medical CenterRoseville, CA
More Trial Locations
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Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Amivantamab: First Approval. [2021]Amivantamab (amivantamab-vmjw; Rybrevant™), a bispecific monoclonal antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET), is being developed by Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). On 21 May 2021, amivantamab received its first approval in the USA for the treatment of adult patients with locally advanced or metastatic NSCLC harbouring EGFR Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Amivantamab is in preregistration for NSCLC in the EU, Australia, Japan, Canada, Switzerland and China. This article summarizes the milestones in the development of amivantamab leading to this first approval for NSCLC.
Amivantamab: A New Hope in Targeting Non-small Cell Lung Cancer. [2023]Amivantamab was approved on May 21st, 2021, by United States food and drug administration with the brand name Rybervant, used particularly for adult patients with exon20 insertion of epithelial growth factor receptor with locally advanced metastatic non-small cell lung cancer.
Amivantamab-Vmjw: A Novel Treatment for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutation after Progression on Platinum-Based Chemotherapy. [2023]This study is a comprehensive review of the clinical pharmacology, pharmacokinetics, efficacy, safety, and clinical applicability of amivantamab-vmjw for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutation.
FDA Approval Summary: Amivantamab for the Treatment of Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. [2023]The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal-epithelial transition receptor, on May 21, 2021, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Approval was based on results of an ongoing, multicenter, nonrandomized, open-label, multicohort clinical trial (CHRYSALIS, NCT02609776), demonstrating a substantial overall response rate (ORR) and durable responses, with an ORR of 40% [95% confidence interval (CI): 29-51] and a median response duration of 11.1 months (95% CI: 6.9-not evaluable). Guardant360 CDx was contemporaneously approved as a companion diagnostic for this indication to identify EGFR exon 20 insertion mutations in plasma specimens. The most notable safety finding was the high incidence (66%) of infusion-related reactions, which is addressed in both the Dosage and Administration and Warnings and Precautions sections of the product label. Other common adverse reactions (occurring in ≥20% of patients) were rash, paronychia, musculoskeletal pain, dyspnea, nausea and vomiting, fatigue, edema, stomatitis, cough, and constipation. The approval of amivantamab was the first approval of a targeted therapy for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations.
Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Amivantamab has been approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions who have had disease progression during or after platinum-based chemotherapy. Phase 1 data showed the safety and antitumor activity of amivantamab plus carboplatin-pemetrexed (chemotherapy). Additional data on this combination therapy are needed.
BRIEF REPORT: Real-world efficacy and safety of amivantamab for EGFR-mutant non-small cell lung cancer (NSCLC). [2023]Amivantamab-vmjw (amivantamab) is a bispecific EGFR/MET antibody approved for patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations, after prior therapy. However, the benefits and safety of amivantamab in other EGFR-mutation lung cancer, with or without osimertinib, and with concurrent radiation therapy, are less known.