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A+C in Metastatic Lung Adenocarcinoma Cancer

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ClinicalTrials.gov Identifier: NCT02946359
Recruitment Status : Unknown
Verified November 2016 by yihu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : October 27, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
yihu, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE October 24, 2016
First Posted Date  ICMJE October 27, 2016
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • 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 ]
  • Response rate in patients with ALK translocation or ROS1 translocation or MET amplification [ 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 [ 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 ]
    Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A+C in Metastatic Lung Adenocarcinoma Cancer
Official Title  ICMJE Crizotinib Combined With Bevacizumab as First-line Therapy in Metastatic Lung Adenocarcinoma Cancer With ALK Translocation or MET Amplification or ROS1 Translocation (CAMAR)
Brief 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
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Adenocarcinoma Metastatic
Intervention  ICMJE Drug: Crizotinib, bevacizumab
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
Other Name: XALKORI,AVASTIN
Study Arms  ICMJE
  • Experimental: Patients with ALK translocation
    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
    Intervention: Drug: Crizotinib, bevacizumab
  • Experimental: Patients with ROS1 translocation
    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
    Intervention: Drug: Crizotinib, bevacizumab
  • Experimental: Patients with MET amplification
    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
    Intervention: Drug: Crizotinib, bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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). 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02946359
Other Study ID Numbers  ICMJE CAMAR01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party yihu, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP