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A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Profile

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2024

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At a glance

  • Drugs Amivantamab (Primary) ; Carboplatin (Primary) ; Pemetrexed (Primary) ; Vitamins
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PAPILLON
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 24 Sep 2024 According to a Johnson & Johnson media release, company announced that it has received manufacturing and marketing approval in Japan for Livelivant. This approval is based on results from the Phase 3 PAPILLON trial.
    • 03 Jul 2024 According to a Johnson & Johnson media release, based on results from this trial Health Canada, through a Priority Review, has issued a Notice of Compliance for RYBREVANT(amivantamab) in combination with platinum-based chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor Exon 20 insertion mutations.
    • 28 Jun 2024 According to a Janssen-Cilag International NV media release, based on positive results from this trial, European Commission (EC) has approved a Type II variation for RYBREVANT (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

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