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A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06667076
Protocol IDs
61186372NSC2012 (primary)
NCI-2025-00167
61186372NSC2012
Study Sponsor
Janssen Research & Development, LLC

Summary

The primary purpose of the study is to assess how well amivantamab subcutaneous (SC)
administration in combination with lazertinib or in combination with chemotherapy works
(antitumor activity) in participants with epidermal growth factor receptor mutated
(EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung
cancer).

Eligibility

  1. Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
  2. 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
  3. Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
  4. 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)
  5. Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.