A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Janssen Research & Development, LLC
Summary
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Par…
Interventions
- DrugAmivantamab
Amivantamab will be administered subcutaneously by manual injection.
- DrugLazertinib
Lazertinib will be administered as an oral tablet.
- DrugCarboplatin
Carboplatin will be administrated by IV infusion.
- DrugPemetrexed
Pemetrexed will be administered by IV infusion.
- DrugDirect Oral Anticoagulant (DOAC)
DOAC will be administered orally.
- DrugLow Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.
Locations (110)
- University of California at San DiegoLa Jolla, California
- University of California IrvineOrange, California
- Stanford Cancer InstituteStanford, California
- Johns Hopkins Office of Capital Region Research - Sibley Memorial HospitalWashington D.C., District of Columbia
- Baptist Lynn Cancer InstituteBoca Raton, Florida
- Mount Sinai Medical CenterMiami Beach, Florida