Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)
NCT ID: NCT02499614
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2014-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with MET amplification or MET exon 14 mutation
Pretreated NSCLC patients with MET amplification or MET exon 14 mutation with locally advanced or metastatic NSCLC and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o until disease progression, unacceptable toxicity or patient refusal.
Crizotinib
Eligible patients with ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID. The dose of crizotinib may be adjusted depending on the type and severity of toxicity encountered
Patients with ROS1 translocation
Pretreated NSCLC patients with ROS1 translocation with locally advanced or metastatic NSCLC and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o until disease progression, unacceptable toxicity or patient refusal.
Crizotinib
Eligible patients with ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID. The dose of crizotinib may be adjusted depending on the type and severity of toxicity encountered
Interventions
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Crizotinib
Eligible patients with ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID. The dose of crizotinib may be adjusted depending on the type and severity of toxicity encountered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Availability of tumor tissue for ROS1 and MET analyses
* Patient positive for ROS1 translocation or MET amplification
* At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )
* At least 1 previous standard chemotherapy regimen
* Performance status 0-2 (ECOG)
* Patient compliance to trial procedures
* age ≥ 18 years
* Written informed consent
* Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB \> 9g/dl)
* Adequate liver function (bilirubin \<G2, transaminases no more than 3xULN/\<5xULN in present of liver metastases).
* Normal level of alkaline phosphatase and creatinine.
* If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method \[intrauterine contraceptive device (IUD), birth control pills, or barrier device\] during and for ninety(90) days after end of treatment.
Exclusion Criteria
* Absence of any measurable lesion
* For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agent
* For MET amplified patients: Evidence of MET amplification in tumor tissue collected in EGFR mutant patient at time of EGFR-TKI acquired resistance occurrence. An EGFR mutant patient is eligible if MET amplification is detected in a tumor specimen collected before starting an EGFR-TKI
* No previous chemotherapy
* Concomitant radiotherapy or chemotherapy.
* Previous radiotherapy on the target lesion(s). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
* Symptomatic brain metastases
* Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin
* Pregnancy or lactating
* Other serious illness or medical condition potentially interfering with the study
18 Years
ALL
No
Sponsors
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Fondazione Ricerca Traslazionale
OTHER
Responsible Party
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Principal Investigators
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Lucio Crinò
Role: PRINCIPAL_INVESTIGATOR
Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
Locations
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IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica
Meldola, Forlì- Cesena, Italy
Ospedale Versilia- Oncologia
Camaiore, Lucca, Italy
Ospedale per gli Infermi - Presidio Ospedaliero di Faenza- Unità Operativa di Oncologia Medica
Faenza, Ravenna, Italy
Ospedale Umberto I°- Unità Operativa di Oncologia
Lugo, Ravenna, Italy
A. O. "Ospedale di Circolo" di Busto Arsizio- Struttura Complessa di Oncologia Medica
Saronno, Varese, Italy
Sacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica
Negrar, Verona, Italy
Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8
Arezzo, , Italy
Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"- U.O. di Oncologia Medica
Avellino, , Italy
IRCCS Istituto Tumori "Giovanni Paolo II"- U.O. Oncologia Medica
Bari, , Italy
A.O.U. Careggi- S.C. Oncologia Medica 1
Florence, , Italy
IRCCS A.O.U. San Martino- IST- Istituto Nazionale per la Ricerca sul Cancro- U.O.S. Tumori Polmonari
Genova, , Italy
Ospedale Civile Livorno- U.O. Dipartimento di Oncologia Medica
Livorno, , Italy
Ospedale Campo di Marte- U.O.C. di Oncologia Medica
Lucca, , Italy
Istituto Europeo di Oncologia - Divisione di Oncologia Toracica
Milan, , Italy
A.O.U. Policlinico di Modena- Oncologia Ematologia e Malattie Apparato Respiratorio
Modena, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"- Oncologia Medica Dipartimento Toraco-Polmonare
Napoli, , Italy
A.O.U. "Maggiore della Carità"- Dipartimento Oncologico
Novara, , Italy
Istituto Oncologico Veneto IRCCS- UOS Oncologia Toracica UOC. Oncologia Medica 2
Padua, , Italy
Casa di Cura La Maddalena- U.O. Oncologia medica
Palermo, , Italy
Azienda Ospedaliera Universitaria di Parma- Struttura Complessa di Oncologia Medica
Parma, , Italy
Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana (AOUP)- Pneumo-Oncologia - Dipartimento Cardio-Toracico
Pisa, , Italy
Ospedale di Ravenna- Oncologia Medica
Ravenna, , Italy
Ospedale "Infermi" Rimini- UU.OO. Oncologia ed Ematologia
Rimini, , Italy
Osp. Civile SS. Annunziata- U.O.C di Oncologia Medica
Sassari, , Italy
Policlinico 'G.B.Rossi' Borgo Roma - A.O.U. Integrata (Giampaolo Tortora)- Oncologia Medica
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Angelo Delmonte
Role: primary
Stefano Tamberi
Role: primary
Claudio Dazzi
Role: primary
Claudio Verusio
Role: primary
Stefania Gori
Role: primary
Sergio Bracarda
Role: primary
Cesare Gridelli
Role: primary
Domenico Galetta
Role: primary
Francesco Di Costanzo
Role: primary
Francesco Grossi
Role: primary
Federico Cappuzzo
Role: primary
Filippo De Marinis, MD
Role: primary
Fausto Barbieri
Role: primary
Alessandro Morabito
Role: primary
Gloria Borra
Role: primary
Adolfo Favaretto
Role: primary
Vittorio Gebbia
Role: primary
Marcello Tiseo
Role: primary
Lucio Crinò, MD
Role: primary
Antonio Chella
Role: primary
Federico Cappuzzo
Role: primary
Maximilian Papi
Role: primary
Emilio Bria
Role: primary
References
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Chiari R, Ricciuti B, Landi L, Morelli AM, Delmonte A, Spitaleri G, Cortinovis DL, Lamberti G, Facchinetti F, Pilotto S, Verusio C, Chella A, Bonanno L, Galetta D, Cappuzzo F. ROS1-rearranged Non-small-cell Lung Cancer is Associated With a High Rate of Venous Thromboembolism: Analysis From a Phase II, Prospective, Multicenter, Two-arms Trial (METROS). Clin Lung Cancer. 2020 Jan;21(1):15-20. doi: 10.1016/j.cllc.2019.06.012. Epub 2019 Jun 18.
Related Links
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Fondazione FoRT
Other Identifiers
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FoRT 01/2014
Identifier Type: -
Identifier Source: org_study_id