A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: |
Janssen Research & Development, LLC |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAT2776 |
U.S. Govt. ID: |
NCT04538664 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to see if amivantamab in combination with administration of standard of care chemotherapy (carboplatin and pemetrexed) is safe and useful for treating patients with Non-Small Cell Lung Cancer (NSCLC), specifically in patients with a gene abnormality called EGFR Exon 20 insertions. There are two study arms for this trial. Patients on Study Treatment Arm A will receive the investigational drug (amivantamab) in addition to standard of care chemotherapy and Study Treatment Arm B will only receive standard of care chemotherapy. Some procedures involved with the study include genetic testing, physical exams, tumor assessments such as MRIs and CTs, and blood draws.
This study is closed
Investigator
Catherine Shu, MD
Are you at least 18 years old? |
Yes |
No |
Do you have locally advanced or metastatic, nonsquamous NSCLC? |
Yes |
No |
You do have untreated brain metastases? |
Yes |
No |
Do you have a history of leptomeningeal disease? |
Yes |
No |