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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04965090
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    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.
  • Lazertinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2021
Status verified
Dec 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with parenchymal brain metastases
    All patients in both cohorts will receive both oral lazertinib and amivantamab by intravenous injection (IV). Lazertinib dosing will start at 240 mg daily. For patients who weigh \<80 kg, on C1D1 amivantamab 350 mg will be given IV via peripheral line for C1D1, D2 and D8, with 700 mg IV given on C1D2. For all other treatments, amivantamab 1050 mg IV will be given. For patients who weigh ≥ 80 kg, on C1D1 350mg IV amivantamab will be given and 1050 mg IV on C1D2, with 1400 mg IV given for all.
  • Experimental: Patients with leptomeningeal (LM) disease with or without parenchymal brain metastases
    All patients in both cohorts will receive both oral lazertinib and amivantamab by intravenous injection (IV). Lazertinib dosing will start at 240 mg daily. For patients who weigh \<80 kg, on C1D1 amivantamab 350 mg will be given IV via peripheral line for C1D1, D2 and D8, with 700 mg IV given on C1D2. For all other treatments, amivantamab 1050 mg IV will be given. For patients who weigh ≥ 80 kg, on C1D1 350mg IV amivantamab will be given and 1050 mg IV on C1D2, with 1400 mg IV given for all.

Primary Outcome Measure

CNS overall response rate (ORR) (Cohort 1) [ Time Frame: 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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