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RecruitingLast updated:15 August 2023

PALOMA-3: This phase III study aims to simplify the administration of a targeted therapy (amivantamab), by assessing a new formulation and administration method, for the treatment of non-small cell lung cancerA Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Clinical summary

Summary

This study is seeking to simplify the administration of amivantamab intravenous (IV) administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF) for subcutaneous administration. This has the potential to enhance both the patient and physician experience by providing easier and accelerated administration. Eligible participants will be randomly allocated to one of two Experimental Arms. In Experimental Arm A, participants will receive Lazertinib (240mg) will be administered orally once daily, plus Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF) (1600mg / 2240mg depending on the body weight) administered by manual injection. In Experimental Arm B, participants will receive Lazertinib (240mg) administered once daily, plus Amivantamab (1050mg or 1400mg depending on the body weight) administered as an IV infusion.

Age

People18+

Phase

III

Trial Acronym

PALOMA-3

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Trial Identifiers

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Commercial Sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
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