Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification or MET exon 14 mutation
This is a phase II, prospective, two arms, parallel, non comparative study with crizotinib in pretreated NSCLC patients with ROS1 translocation or MET amplification or MET exon 14 mutation (figure 1). Patients with locally advanced or metastatic NSCLC, pretreated with at least one previous chemotherapy line and with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for MET and ROS1 by FISH to detect MET amplification or ROS1 translocation. MET mutation will be assessed using direct sequencing or high sensitive methods. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or MET exon 14 mutation or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o until disease progression, unacceptable toxicity or patient refusal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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
Response rate to crizotinib in patients with ROS1 translocation or MET amplification or MET exon 14 mutation
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
Progression-free survival (PFS)
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
Overall Survival (OS)
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
Toxicity analysis: Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
Correlation with additional tumor biomarkers in tumor tissue or blood
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
Response according to different levels of ROS1 translocation or MET amplification (ratio >2.2 and <5 versus ratio ≥ 5) or MET exon 14 mutation
Time frame: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica
Meldola, Forlì- Cesena, Italy
RECRUITINGOspedale Versilia- Oncologia
Camaiore, Lucca, Italy
ACTIVE_NOT_RECRUITINGOspedale per gli Infermi - Presidio Ospedaliero di Faenza- Unità Operativa di Oncologia Medica
Faenza, Ravenna, Italy
RECRUITINGOspedale Umberto I°- Unità Operativa di Oncologia
Lugo, Ravenna, Italy
RECRUITINGA. O. "Ospedale di Circolo" di Busto Arsizio- Struttura Complessa di Oncologia Medica
Saronno, Varese, Italy
RECRUITINGSacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica
Negrar, Verona, Italy
RECRUITINGIstituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8
Arezzo, Italy
RECRUITINGAzienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"- U.O. di Oncologia Medica
Avellino, Italy
RECRUITINGIRCCS Istituto Tumori "Giovanni Paolo II"- U.O. Oncologia Medica
Bari, Italy
RECRUITINGA.O.U. Careggi- S.C. Oncologia Medica 1
Florence, Italy
RECRUITING...and 16 more locations