Lung Cancer Clinical Trial
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
Summary
This study will 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).
Eligibility Criteria
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
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
Other protocol defined exclusion criteria could apply.
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There are 49 Locations for this study
Yuma Arizona, 85364, United States
Fountain Valley California, 92708, United States
Long Beach California, 90806, United States
Oxnard California, 93030, United States
Whittier California, 92801, United States
Norwich Connecticut, 06360, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32256, United States
Miami Florida, 33136, United States
Ocala Florida, 34474, United States
Athens Georgia, 30607, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60637, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46250, United States
South Bend Indiana, 46601, United States
Louisville Kentucky, 40202, United States
Hammond Louisiana, 70433, United States
Baltimore Maryland, 21237, United States
Bethesda Maryland, 20817, United States
Frederick Maryland, 21702, United States
Boston Massachusetts, 02118, United States
Fairhaven Massachusetts, 02719, United States
Lansing Michigan, 48912, United States
Bolivar Missouri, 65613, United States
Bridgeton Missouri, 63044, United States
Saint Joseph Missouri, 64507, United States
Las Vegas Nevada, 89169, United States
Belleville New Jersey, 07109, United States
Florham Park New Jersey, 07932, United States
New York New York, 10016, United States
New York New York, 10016, United States
New York New York, 10021, United States
Goldsboro North Carolina, 27534, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Tulsa Oklahoma, 74146, United States
Salem Oregon, 97301, United States
Gettysburg Pennsylvania, 17325, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57108, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37201, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Ogden Utah, 84405, United States
Salt Lake City Utah, 84106, United States
Fredericksburg Virginia, 22408, United States
Tacoma Washington, 98405, United States
Edegem , , Belgium
Gasthuisberg , , Belgium
Roeselare , , Belgium
Changchun , , China More Info
Principal Investigator
Chengdu , , China More Info
Principal Investigator
Hangzhou , , China More Info
Principal Investigator
Harbin , , China More Info
Principal Investigator
Linyi , , China
Shanghai , , China More Info
Principal Investigator
Urumqi , , China
Wuhan , , China More Info
Principal Investigator
Caen Cedex 05 , , France
Creteil Cedex , , France
Limoges , , France
Lyon , , France
Nord , , France
Paris cedex 14 , , France
Paris , , France
Pessac , , France
Toulouse , , France
Dresden , , Germany
Gauting , , Germany
Giessen , , Germany
Göttingen , , Germany
Hamm , , Germany
Hamm , , Germany
Heidelberg , , Germany
Kiel , , Germany
Koeln , , Germany
Leipzig , , Germany
Luebeck , , Germany
Oldenburg , , Germany
Wuerzburg , , Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Lazio , , Italy
Milano , , Italy
Monza , , Italy
Napoli , , Italy
Padova , , Italy
Palermo , , Italy
Pisa , , Italy
Roma , , Italy
Rozzano , , Italy
Varese , , Italy
Verona , , Italy
Hamamatsu-shi , , Japan
Kitaadachi-gun , , Japan
Kurume-shi , , Japan
Nagoya-shi , , Japan
Niigata-shi , , Japan
Nishinomiya-shi , , Japan
Okayama-shi , , Japan
Osaka-shi , , Japan
Osakasayama-shi , , Japan
Ube-shi , , Japan
Yokohama-shi , , Japan
Goyang-si , , Korea, Republic of
Hwasun-gun , , Korea, Republic of
Seongnam-si , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Ulsan , , Korea, Republic of
Kuala Lumpur , , Malaysia
Kuala Lumpur , , Malaysia
Kuantan , , Malaysia
Kuching , , Malaysia
Petaling Jaya, Selangor , , Malaysia
Pulau Pinang , , Malaysia
Selangor , , Malaysia
Amsterdam , , Netherlands
Groningen , , Netherlands
Maastricht , , Netherlands
Krasnoyarsk , , Russian Federation
Moscow , , Russian Federation
Nizniy Novgorod , , Russian Federation
Omsk , , Russian Federation
Pyatigorsk , , Russian Federation
Saint-Petersburg , , Russian Federation
St. Petersburg , , Russian Federation
Connexion , , Singapore
Singapore , , Singapore
Singapore , , Singapore
Badalona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
L'Hospitalet de Llobregat , , Spain
Las Palmas de Gran Canaria , , Spain
Madrid , , Spain
Málaga , , Spain
Palma , , Spain
Pozuelo de Alarcon , , Spain
Sevilla , , Spain
Valencia , , Spain
Kaohsiung , , Taiwan
Taichung , , Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Bangkoknoi , , Thailand
Hat Yai , , Thailand
Muang , , Thailand
Pathumwan , , Thailand
Hanoi , , Vietnam
Hanoi , , Vietnam
Hanoi , , Vietnam
Ho Chi Minh City , , Vietnam
Ho Chi Minh city , , Vietnam
Ho Chi Minh City , , Vietnam
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