OncoMatch/Clinical Trials/NCT05782361
POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC
Is NCT05782361 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Tepotinib and Pembrolizumab for advanced cancer.
Treatment: Tepotinib · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Small Cell Lung Cancer
Biomarker criteria
Required: MET exon 14 mutation
Exon 14 MET mutation (on tissue or ctDNA testing)
Required: PD-L1 (CD274) TPS ≥50% (TPS ≥50%)
Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors)
Performance status
WHO 0–1
Prior therapy
Must have received: MET inhibitor
Patients who have received previous MET inhibitor therapy must have PD-L1 TPS≥50% (not required in those naïve to MET inhibitors)
Cannot have received: immunotherapy
Exception: Patients who have not received prior immunotherapy are eligible
Patients have not received prior immunotherapy
Cannot have received: endocrine therapy
Endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and four weeks for investigational medicinal products), except for bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases.
Cannot have received: chemotherapy
Endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and four weeks for investigational medicinal products), except for bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases.
Cannot have received: investigational medicinal product
Endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and four weeks for investigational medicinal products), except for bisphosphonates or RANK ligand antagonists that are permitted for the management of bone metastases.
Cannot have received: radiotherapy
Radiotherapy at radical doses within 6 months and at palliative doses within 2 weeks.
Lab requirements
Blood counts
Haemoglobin (Hb) ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN; Or GFR ≥ 50 mL/min (uncorrected value); Calculated creatinine clearance (using the Wright, Cockcroft & Gault formula)
Liver function
Serum bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible
Cardiac function
Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs within 5 minutes of each other. Known congenital QT syndrome or history of torsades de pointes. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association [NYHA Grade 2 or above], severe valvular disease, uncontrolled hypertension despite optimal therapy.
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 tumour in which case up to 5 x ULN is permissible Renal function Either: Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Or GFR ≥ 50 mL/min (uncorrected value) Calculated creatinine clearance (using the Wright, Cockcroft & Gault formula) Coagulation INR < 1.5 APTT <1.5x ULN Unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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