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Clinical Trial Details

Cancer Molecular Screening and Therapeutics (MoST) Program Addendum 17 - substudies 38-39: Tepotinib

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionLung - Non small cell

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
The Canberra Hospital - Garran
Peter MacCallum Cancer Centre - Melbourne
The Royal Adelaide Hospital - Adelaide
Royal Darwin Hospital - Tiwi
Royal Hobart Hospital - Hobart
Linear Clinical Research - Nedlands
Princess Alexandra Hospital - Woolloongabba
The Prince Charles Hospital - Chermside
Westmead Hospital - Westmead
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
St George Hospital - Kogarah
Royal North Shore Hospital - St Leonards
Austin Health - Austin Hospital - Heidelberg

Postcode
2605 - Garran
3000 - Melbourne
5000 - Adelaide
0810 - Tiwi
7000 - Hobart
6009 - Nedlands
4102 - Woolloongabba
4032 - Chermside
2145 - Westmead
3065 - Fitzroy
2217 - Kogarah
2065 - St Leonards
3084 - Heidelberg

Anticipated date of first participant enrolment1/07/2021

Anticipated date of last participant enrolment1/07/2023

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tepotinib in a population of participants with metastatic non-small cell lung cancers (NSCLC) harbouring METex14 skipping mutations identified using comprehensive genomic profiling (CGP).

Who is it for?
You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed metastatic NSCLC. Your tumour will need to harbour METex14 skipping mutations identified using CGP.

Study details:
Participants will receive tepotinib treatment. The tepotinib is to be taken orally, at 500mg once daily (days 1 to 21 in a 21-day treatment cycle).
Tepotinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 6 weekly intervals from first treatment until 18 weeks, and then 12 weekly intervals until progression. Safety and tolerability of treatment will be assessed at 3 weekly intervals. Health related quality of life during treatment will be assessed at 3 weekly intervals and then every 9 weeks after end of treatment for 12 months, and then every 12 weeks until progression.

We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tepotinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Eligibility

Key inclusion criteria

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; 
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.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Sydney
Primary Sponsor Address: NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Primary Sponsor Country: Australia

Trial IDACTRN12621000811808

UTNU1111-1182-6652

Contact person for information and recruitmentDr
Lucille Sebastian
NHMRC Clinical Trials Centre Medical Foundation Building Levels 4-6, 92-94 Parramatta Road Camperdown NSW 2050
+61 295625000

Email contact Further information iconmost.study@sydney.edu.au

Australia