Study on Reducing Infusion Reactions with Premedication Before Amivantamab Treatment
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
ClinicalTrials ID:NCT05663866
This clinical trial is exploring whether taking certain medications before receiving amivantamab can help reduce infusion-related reactions in patients with advanced non-small cell lung cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if taking medications like dexamethasone, montelukast, and methotrexate before receiving amivantamab through an IV can lower the chances or severity of reactions that might occur during the first dose. These reactions can happen when the medication is given directly into a vein.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-small cell lung cancer (NSCLC).
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women using oral contraceptives must also use another form of birth control.
- Men must use condoms during sexual activity and for 3 months after the last dose of the study treatment.
- Must agree to participate by signing an informed consent form.
- Have previously been treated with osimertinib and platinum-based chemotherapy, and the cancer has progressed.
- Have a specific type of EGFR-mutated NSCLC, confirmed by a certified laboratory.
Exclusion Criteria
- Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
- Have been treated with certain immune therapies within 6 weeks before starting the study.
- Have unresolved skin rashes from previous treatments.
- Have active symptoms from brain metastases, unless they have been treated and stable for at least 2 weeks.
- Have any side effects from previous cancer treatments that have not returned to a mild level, except for hair loss, mild nerve damage, or stable hypothyroidism on treatment.
- Have previously been treated with amivantamab or lazertinib.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Compassionate Cancer Care | 92708 | Fountain Valley | California |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
| UW Medicine Valley Medical Center | 98055 | Renton | Washington |
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