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This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification
This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification. Patients with locally advanced or metastatic NSCLC(Stage ⅢB/ⅢC/Ⅳ) with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for ALK、MET and ROS1 by FISH or IHC or NGS to detect MET amplification or ALK translocation or ROS1 translocation After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or ALK translocation or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o and bevacizumab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ALK translocation | Experimental | Treatment-naive lung adenocarcinoma cancer patients with ALK translocation with locally advanced or metastatic lung adenocarcinoma cancer 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 combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal |
|
| Patients with ROS1 translocation | Experimental | Treatment-naive lung adenocarcinoma cancer patients with ROS1 translocation with locally advanced or metastatic lung adenocarcinoma cancer 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 combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal |
|
| Patients with MET amplification | Experimental | Treatment-naive lung adenocarcinoma cancer patients with MET amplication with locally advanced or metastatic lung adenocarcinoma cancer 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 combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib, bevacizumab | Drug | Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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 rate in patients with ALK translocation or ROS1 translocation or MET amplification |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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| 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 | Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0 | 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 |
| PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| D011725 |
| Pyridines |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |