A+C in Metastatic Lung Adenocarcinoma Cancer (NCT02946359) | Clinical Trial Compass
UnknownPhase 2
A+C in Metastatic Lung Adenocarcinoma Cancer
China60 participantsStarted 2016-07
Plain-language summary
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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of lung adenocarcinoma cancer
* Availability of tumor tissue for ROS1, ALK, MET analyses
* EGFR was wild type, positive for ROS1 translocation or ALK translocation or MET amplification
* At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )
* Patient didn't received any therapy for lung cancer before except surgery or radiotherapy, or the adjuvant chemotherapy had stopped for more than 12 months
* 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:
* Patients with EGFR mutation
* No tumor tissue available or patient negative for ALK translocation or ROS1 translocation or MET amplification
* Absence of any measurable lesion
* Prior therapy with bevacizumab or ipilimumab
* Symptomatic brain metastases
* Previous radiotherapy on the target lesion(s…
What they're measuring
1
Progression-free survival (PFS)
Timeframe: 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