Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

PALOMA-3 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

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 cancer.
 

This trial is treating patients with non-small cell lung cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Commercial Sponsor

Janssen Research & Development, LLC

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Rachel McMenamin
PCCTU.MoncB@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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