A+C in Metastatic Lung Adenocarcinoma Cancer

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Bevacizumab; Crizotinib

Criteria

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 (bilirubinpresent 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). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.

• 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

• Significant known vascular disease

• Symptomatic peripheral vascular disease

• Evidence of bleeding diathesis or coagulopathy

• Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment

• Serious, non-healing wound, ulcer or bone fracture

• Proteinuria at screening

• Known hypersensitivity to any component of bevacizumab

• History of hemoptysis within 3 months prior to study enrollment

• Current, ongoing treatment with full-dose warfarin or its equivalent