Tepotinib plus osimertinib in osimertinib-relapsed MET amplified NSCLC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks, Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria: Radiological documentation of disease progression on first-line osimertinib Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (>) 6 months after initiation of osimertinib, Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting, MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening, Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing, Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment

Exclusion Criteria

Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention, Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia, Inadequate hematological, liver and renal function, Impaired cardiac function, History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment, Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 millimeter of mercury (mmHg), Contraindication to the administration of osimertinib

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

CompletedPhase 2

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Updated 4/15/2024

This study will look at whether the study drug Tepotinib works to stop the regrowth of your lung cancer. The study drug will be used in combination with an approved lung cancer medication called osimertinib,which is an EGFR inhibitor. This is a Phase II study, which means that the study drug has already been tested in a small number of people in previous clinical research studies.Only patient who have progressed on first-line osimertinib due to MET amplification will be enrolled in the study

Phase 1

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Updated 4/4/2022

This study will look at whether the study drug Tepotinib works to stop the regrowth of your lung cancer. The study drug will be used in combination with an approved lung cancer medication called osimertinib, which is an EGFR inhibitor.

Phase 1

MERCK HEALTHCARE KGaA

Updated 8/30/2021

This study will look at whether the study drug Tepotinib works to stop the re-growth of your lung cancer. The study drug will be used in combination with an approved lung cancer medication called osimertinib, which is an EGFR inhibitor. This is a Phase II study, which means that the study drug has already been tested in a small number of people in previous clinical research studies. Only patient who have progressed on first-line osimertinib due to MET amplification will be enrolled in the study

Phase 1

Merck Healthcare KGaA

Updated 7/15/2024

This study will look at whether the study drug Tepotinib works to stop the regrowth of your lung cancer. The study drug will be used in combination with an approved lung cancer medication called osimertinib, which is an EGFR inhibitor. This is a Phase II study, which means that the study drug has already been tested in a small number of people in previous clinical research studies.Only patient who have progressed on first-line osimertinib due to MET amplification will be enrolled in the study

Phase 1

Merck Healthcare KGaA

Updated 7/15/2024