Copernicus

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1012796

• Contact name

  Kanita Theivendran

• Contact email

  ktheiven@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• ISRCTN Number

  ISRCTN12138139

• Clinicaltrials.gov Identifier

  NCT06667076

• Research summary

  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes including mesenchymal-epithelial transition (MET) and EGFR. Although treatment options are available only a few patients respond to the treatment or cancer can come back after treatment. Drugs that target EGFR to attack cancer cells may be an effective way to destroy them. The study aims to assess the effectiveness of the combination of amivantamab and lazertinib as first-line treatment and combination of amivantamab and chemotherapy as second-line treatment in participants with NSCLC with specific mutation in the EGFR gene.

  The study will include the following phases:
  1. Screening Phase (up to 28 days): Participants aged 18 years or above will be screened.
  2. Treatment Phase (until end of treatment): Participants will be put into one of the 2 cohorts:
  o Cohort 1-Includes participants who have not received any prior cancer therapy. Participants will receive amivantamab as an injection under the skin (SC) along with lazertinib orally according to the treatment schedule.
  o Cohort 2- Includes second-line participants who have progressed on or after EGFR-TKI cancer therapy. Participants will receive amivantamab as SC injection along with standard chemotherapy (carboplatin and pemetrexed) by injection into a vein as per treatment schedule.
  3. Follow-up Phase: Participants will be followed up to monitor their overall health until the end of study, death, progression of the disease, or withdrawal of consent, whichever comes first.

  The UK will participate in Cohort 1 only.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  25/LO/0698

• Date of REC Opinion

  21 Oct 2025

• REC opinion

  Further Information Favourable Opinion