Active — Not RecruitingPhase 1

POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

United Kingdom19 participantsStarted 2023-05-03

Plain-language summary

This clinical study is looking at the combination of two experimental drugs called tepotinib and pembrolizumab. Pembrolizumab, also known as Keytruda, is licenced and available by prescription to treat a variety of cancers. Tepotinib is currently licensed in the UK for use in non-small cell lung cancer (NCSLC) and is being investigated for this purpose. Cancer immunotherapy drugs hold great promise but still do not work for many patients. Laboratory studies on cancers that do not respond well to immunotherapy reveal that most of these tumours do not have any immune cells. This suggests that the cancer has successfully hidden itself and avoided being recognised by the immune system. This study aims to use a novel approach using a targeted drug, tepotinib, to target the gene involved with NSCLC. Tepotinib is a type of drug called a kinase inhibitor. Kinase inhibitors are a newer type of drug being used to try to treat cancers. They act by blocking some of the chemical messengers that are part of the signalling process within cancer cells that control their growth. Tepotinib is used in adults to treat NSCLC that can have certain abnormal changes in the mesenchymal-epithelial transition factor gene (MET) and which has spread and/or cannot be removed by surgery. The changes in the MET gene can make an abnormal protein which can lead to uncontrolled cell growth and cancer. By blocking this abnormal protein, tepotinib may slow or stop the cancer from growing as well as potentially shrinking the cancer. This study will include patients with and without the MET exon 14 mutations. In this clinical study, the investigators aim to test our ideas in a small number of people for the first time, specifically in those patients with cancers which do not respond to cancer immunotherapy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: 1\. Male or female patients aged 18 or over; 2. Non-small cell lung cancer histologically confirmed; 3. Part A: Either a) Exon 14 MET mutation (on tissue or ctDNA testing); b) Patients have not received prior immunotherapy; c) Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors). Or a) Patient has received at least one line of systemic anticancer therapy for metastatic disease; b) Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose. 4\. Part B: Cohort 1 a) Exon 14 MET mutation (on tissue or ctDNA testing); b) Patients have not received prior immunotherapy; c) Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors). 5\. Measurable disease as assessed by iRECIST 6. Life expectancy of at least 12 weeks. 7. World Health Organisation (WHO) performance status of 0 or 1(Appendix 1). 8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP. Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to tum…

What they're measuring

Anti-tumour activity evaluation (in Part B)

Timeframe: 24 Months

Trial details

NCT IDNCT05782361

SponsorInstitute of Cancer Research, United Kingdom

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-08