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Closed (no longer recruiting)Last updated: 2 February 2024

MoST Addendum 17 (substudies 38-39): This Phase II trial is trying to understand the effect of targeted therapy (tepotinib) in people with advanced non-small cell lung cancer.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

Clinical summary

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.

Conditions

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

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

MoST Addendum 17 (substudies 38-39)

More information

Trial Identifiers

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

Trial sponsor

Merck, University of Sydney, Australian Genomic Cancer Medicine Centre

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

Eligibility

Inclusion

 

1. Adults, aged 18 years and older, with newly diagnosed metastatic non-squamous NSCLC;
2. METex14 skipping mutation identified using CGP;
3. Confirmation of molecular eligibility by the molecular tumour board;
4. Measurable disease as assessed by RECIST 1.1; In the event of evaluable but non-measurable disease, eligibility must be confirmed by the ASPiRATION study chair or delegate through contacting the NHMRC CTC;
5. ECOG 0 to 2;
6. Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
a. bone marrow function; platelets greater than or equal to 100 x 10^9/L, ANC greater than or equal to 1.5 x 10^9/L, and haemoglobin greater than or equal to 90g/L (5.6mmol/L);
b. liver function; ALT/AST less than or equal to 3xULN (in the absence of liver metastases, less than or equal to 5xULN for patients with liver involvement) and total bilirubin less than or equal to 1.5xULN;
c. renal function; serum creatinine less than or equal to 1.5xULN;
7. Life expectancy greater than or equal to 12 weeks;
8. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
9. Signed, written informed consent to participation in the specific treatment substudy.

Exclusion

1. Prior systemic therapy for advanced disease. Up to two cycles of systemic therapy (excluding prior MET inhibitor treatment) while awaiting the results of CGP testing are permitted.
2. Prior MET/HGF pathway inhibitor treatment;
3. Known history of hypersensitivity or contraindication to tepotinib;
4. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with tepotinib, including:
a. Known history of interstitial lung disease or drug-induced pneumonitis requiring steroid treatment
b. Congenital QT syndrome or baseline QTc >500ms
5. Active CNS involvement. Patients with stable neurological function, on stable anticonvulsants and/or steroids less than or equal to 10 mg prednisone equivalent over 4 weeks are eligible;
6. Co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
7. Treatment with any of the following anti-cancer therapies prior to the first dose of tepotinib:
a. Radiation therapy, major surgery, or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
b. Any systemic therapy within 28 days prior to the first dose of tepotinib;
8. Administration of any investigational treatment within 28 days prior to receiving the first dose of tepotinib;
9. Prior or concurrent malignancy. History of another primary malignancy except for:
a. Malignancy treated with curative intent and with no known active disease within 2 years before consent to molecular screening and of low potential risk for recurrence;
b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease;
c. Adequately treated carcinoma-in-situ without evidence of disease;
10. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Inclusion

  • You are able to swallow medication by mouth.
  • You are currently receiving treatment for your cancer.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • 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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