Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called amivantamab (the study drug) when it is given in combination with lazertinib and chemotherapy. We want to know if this study drug regimen is effective for people with non-small cell lung cancer (NSCLC) who have a specific mutation in the EGFR (epidermal growth factor receptor) gene.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with advanced or metastatic NSCLC)
- Have a documented EGFR mutation (specifically, an Ex19del or Ex21 L858R substitution)
- Do not have an adequate response to standard curative therapy
- Do not have interstitial lung disease or any form of chronic liver disease
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study consists of 2 cohorts, Cohort 1 and Cohort 2.
Cohort 1
If you choose to join this study and take part in Cohort 1, you will:
- Get the study drug as an injection (shot under the skin)
- Take lazertinib tablets once each day
- Take an an oral or injectable medication during the first 4 months of study drug to prevent or reduce the likelihood and severity of blood clots
- Take medications to prevent the known possible side effects of the study drug and lazertinib (e.g., skin and/or nail rash)
- Get the study drug as an injection (shot under the skin)
- Get chemotherapy (carboplatin and pemetrexed)
- Take medications to prevent the known possible side effects of the study drug (e.g., skin and/or nail rash)
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Principal Investigator
Eziafa
Oduah
Protocol Number
PRO00117232
NCT ID
NCT06667076
Phase
II
Enrollment Status
Pending Open to Enrollment