Subcutaneous Amivantamab With Lazertinib or Subcutaneous Amivantamab With Chemotherapy in EGFR-Mutated Non-Small Cell Lung Cancer

What is the Purpose of this Study?

This study focuses on people with non-small cell lung cancer (NSCLC) who have a specific mutation in a gene called the epidermal growth factor receptor (EFGR) gene. The purpose of the study is to learn more about the effectiveness and safety of the combination of a drug called amivantamab (given under the skin) and chemotherapy, as well as the effectiveness and safety of the combination of amivantamab (given under the skin) and another drug, lazertinib. Patients will be asked to participate in 1 of 2 groups, based on their prior treatment history for NSCLC. In Group 1, participants will receive amivantamab injection (under the skin) and lazertinib (daily by mouth). In Group 2, participants will receive amivantamab injection and chemotherapy (carboplatin and pemetrexed). Study procedures for both groups include physical exams, blood and urine sample collection, imaging scans, and tumor biopsy. Amivantamab is an antibody, which is a protein that specifically recognizes and binds to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Lazertinib belongs to a class of drugs called EGFR tyrosine kinase inhibitors. When a tyrosine kinase inhibitor binds to EGFR on a cancer cell, the growth of the cell is slowed down or stopped. While amivantamab and lazertinib are approved by the U.S. Food and Drug Administration (FDA), the use of amivantamab given as an injection under the skin in this study is investigational.


Eligibility

  • * Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
  • * Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory in accordance with site standard of care
  • * Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
  • * Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Garrett Crook

More about this Clinical Trial

What is the full name of this clinical trial?

61186372NSC2012: 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

Study Details
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Co-Investigators

Kamya Sankar, Navid Hafez

Age Group

Adult

Phase

II

IRB Number

STUDY00003821

ClinicalTrials.gov ID

NCT06667076

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Lung

Principal Investigator

Reckamp, Karen

Age Group

Adult

Phase

II

IRB Number

61186372NSC2012

ClinicalTrials.gov ID

NCT06667076

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org