NCT04965090

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Single-Arm Study of Amivantamab (JNJ-61186372) and Lazertinib in Metastatic EGFR-mutant Lung Cancer With Progressive or New CNS Metastases on Previous Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation. Both drugs work to target cancer cells with an EGFR mutation, and this targeting action could stop or slow the growth of cancer cells. The researchers are doing this study to find out how well amivantamab and lazertinib work against metastatic NSCLC with an EGFR mutation.

Conditions

• Metastatic Non Small Cell Lung Cancer
• Recurrent Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amivantamab	Amivantamab 1050mg IV once weekly for the first 28 days (Cycle 1) and every other week thereafter. For subjects who weigh ≥80 kg, they will receive 350mg IV on C1D1 and 1050 mg on C1D2. They will continue to receive amivantamab 1400 IV once weekly for the first 28 days and every other week thereafter. Each cycle is 28 days in length.
DRUG	Lazertinib	Lazertinib 240 mg orally once daily and take this continuously, starting C1D1. For patients who weigh \<80 kg, on C1D1, patients will receive amivantamab 350 mg IV, with 700 mg given on C1D2.

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2021-07-16
• Last updated: 2025-12-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study