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A+C in Metastatic Lung Adenocarcinoma Cancer

Primary Purpose

Lung Adenocarcinoma Metastatic

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Crizotinib, bevacizumab
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma Metastatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese PLA General HospitalRecruiting
  • PLA general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients with ALK translocation

Patients with ROS1 translocation

Patients with MET amplification

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall Survival (OS)
Response rate in patients with ALK translocation or ROS1 translocation or MET amplification
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

Full Information

First Posted
October 24, 2016
Last Updated
November 1, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02946359
Brief Title
A+C in Metastatic Lung Adenocarcinoma Cancer
Official Title
Crizotinib Combined With Bevacizumab as First-line Therapy in Metastatic Lung Adenocarcinoma Cancer With ALK Translocation or MET Amplification or ROS1 Translocation (CAMAR)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with ALK translocation
Arm Type
Experimental
Arm Description
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
Arm Title
Patients with ROS1 translocation
Arm Type
Experimental
Arm Description
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
Arm Title
Patients with MET amplification
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Crizotinib, bevacizumab
Other Intervention Name(s)
XALKORI,AVASTIN
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Toxicity analysis: Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haitao tao, PhD
Phone
+861066937875
Email
whatyouknow@126.com
Facility Name
PLA general hospital
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yi hu, M.D.
Email
13718994934@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A+C in Metastatic Lung Adenocarcinoma Cancer

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