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MoST Addendum 17 (substudies 38-39) : A single arm, open label, signal-seeking, phase II trial of tepotinib in patients with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Lung<br/>CancersCancer LocationLung
Cancers

Systemic therapy | LungNon-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This Phase II trial is trying to understand the effect of targeted therapy (tepotinib) in people with advanced non-small cell lung cancer..
 

This trial is treating patients with advanced 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 are currently receiving treatment for your cancer.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • 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 single arm, open label, signal-seeking, phase II trial of tepotinib in patients with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling

Cooperative Group

Australian Genomic Cancer Medicine Centre

Commercial Sponsor

Merck

Other Non-Commercial Sponsor

University of Sydney

Summary

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437). This trial is evaluating tepotinib in people with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling. Participants will receive continuous tepotinib, administered orally at a dose of 500mg daily (days 1 to 21 in a21-day treatment cycle). Tepotinib is to be taken continuously with no interruption between cycles. If participants experience any severe (grade 3-4) adverse events, treatment will be withheld until the adverse event is resolved (grade 0-1). If participants experience intolerable toxicity, tepotinib dose may be reduced to 250mg once daily. Participants will receive topotinib until disease progression is documented, intolerable toxicity or withdrawal for another reason.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Nathan Reader Wilson
PCCTU.EDD@petermac.org

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
nadia.ranieri@svha.org.au
03 9231 3167

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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