Tepotinib Phase II study in lung adenocarcinoma harbouring MET exon 14 (METex14) skipping alterations

Phase 1

• Conditions: Stage IIIB/IV adenocarcinoma of the lung with MET exon 14 (METex14) skipping alterations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005696-24-FR
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Histologically confirmed advanced adenocarcinoma of the lung, having failed at least one line of systemic therapy, including a platinum-doublet-containing regimen, but having failed a maximum of 2 lines of active therapy;
2. METex14 skipping alterations, as determined by the central laboratory. Both, archival and
fresh biopsies are acceptable; In case METex14 skipping alteration has been observed in a subject in a pre-trial setting, it should be ensured that sufficient tissue is available for re-testing before trial entry. Only subjects with METex14 skipping mutation based on trial central testing will be
enrolled into the trial.
3. Signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure;
4. Male or female, = 18 years of age (or having reached the age of majority according to local laws and regulations, if the age of majority is > 18 years of age);
5. Measurable disease in accordance with RECIST version 1.1;
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Subjects with characterized EGFR (documented results; local testing acceptable) that predict sensitivity to EGFR-therapy, including, but not limited to exon 19 deletions and exon 21 alterations;
2. Subjects with characterized ALK rearrangements (documented results; local testing acceptable);
3. Active brain metastases (defined as neurologically stable for < 4 weeks and/or symptomatic and/or requiring treatment with steroids and/or leptomeningeal disease). Subjects must have completed any prior treatment for brain metastases = 4 weeks prior to start of therapy (= 2 weeks for stereotactic radiosurgery/gamma knife). Subjects who are neurologically stable on symptomatic therapy with anticonvulsants with low drug interaction risk or whose steroids
are being tapered are eligible. Asymptomatic untreated brain metastases = 1cm are eligible;
4. Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy;
5. Need for transfusion within 14 days prior to the first dose of trial treatment;
6. Prior chemotherapy, biological therapy, radiation therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment;
7. Inadequate hematological, liver, renal, cardiac function; 8. Prior treatment with other agents targeting the HGF/c-Met pathway; 9. Past or current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years (for a full list of exlustion criteria please see the study protocol).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified