A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT04538664
This study evaluates the efficacy of amivantamab combined with carboplatin-pemetrexed versus carboplatin-pemetrexed alone in advanced NSCLC with EGFR Exon 20ins mutations. Eligible participants must have measurable disease, ECOG status 0-1, and agree to genetic testing. Interventions include amivantamab, pemetrexed, and carboplatin administered via IV infusions.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
Eligibility Criteria
Inclusion Criteria
- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
- Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
- A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria
- Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
- Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
- Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
- Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope 2 | 91010 | Duarte | California |
| University of California Irvine | 92868 | Orange | California |
| UCLA | 90404 | Santa Monica | California |
| Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| H. Lee Moffitt Cancer & Research Institute | 33612 | Tampa | Florida |
| University Cancer And Blood Center LLC | 30607 | Athens | Georgia |
| Henry Ford Hospital | 48202 | Detroit | Michigan |
| Washington University Medical Center | 63110 | St Louis | Missouri |
| Regional Cancer Care Associates LLC | 08816 | East Brunswick | New Jersey |
| Langone Health at NYC University, NYU School of Medicine | 10016 | New York | New York |
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