Informations générales (source: ClinicalTrials.gov)
A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)
Interventional
Phase 2
EMD Serono Research & Development Institute, Inc. (Voir sur ClinicalTrials)
septembre 2019
octobre 2025
24 septembre 2024
This study was to assess the antitumor activity, safety, tolerability, and
pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor
tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants
with advanced or metastatic non-small cell lung cancer (NSCLC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:28:44 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Francois Baclesse - Service d'Oncologie Medicale - Caen Cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée - Limoges - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha - Pessac - France | Contact (sur clinicalTrials) | ||||
| Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie - Nord - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- Other protocol defined inclusion criteria could apply
- 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
- Other protocol defined inclusion criteria could apply
- 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
- Other protocol defined exclusion criteria could apply.