A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amivantamab — DRUG
  Participants will receive amivantamab intravenously.
• Osimertinib — DRUG
  Participants will receive osimertinib capsules orally.
• Lazertinib — DRUG
  Participants will receive lazertinib tablets orally.
• Placebo — DRUG
  Participants will receive matching placebo orally.

Study Details

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Key Dates

Start date

Sep 30, 2020

Status verified

Jun 2026

Primary completion

Aug 11, 2023

Completion

Nov 30, 2027

Study Design

Enrollment

1,074 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm A (Open-label): Amivantamab and Lazertinib
  Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\*3) orally once daily.
• Active Comparator: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
  Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\*3) orally once daily.
• Experimental: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
  Participants will receive lazertinib 240 mg (80\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: From randomization to either disease progression or death whichever occurs first (up to 32.8 months) ]

Locations (20)

Related coverage on Hipa.ai

• Amivantamab + Lazertinib Improves PFS in EGFR+ NSCLC vs Osimertinib
  Amivantamab · Aug 11, 2023 · ClinicalTrials.gov

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