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Closed (no longer recruiting)Last updated: 9 November 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.

Conditions

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

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

PALOMA-3

More information

Trial Identifiers

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Trial 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

  • Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started [US]) or an accredited local laboratory (sites outside of the US)
  • Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
  • Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)

Exclusion

  • Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
  • Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
  • Participant has symptomatic or progressive brain metastases
  • Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
  • Participant has uncontrolled tumor-related pain
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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