Lung Adenocarcinoma MetastaticPhase 2NCT02946359
A+C in Metastatic Lung Adenocarcinoma Cancer
A Phase 2 study testing Crizotinib, bevacizumab in people with Lung Adenocarcinoma Metastatic, run by Chinese PLA General Hospital at 2 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Adenocarcinoma Metastatic
- What is being tested?
- Crizotinib, bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2016to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
haitao tao, PhD, +861066937875, whatyouknow@126.com
- Recruiting
PLA general hospital
Beijing, Beijing Municipality, 100853
yi hu, M.D., 13718994934@126.com
About this study
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)
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
Read the 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.
- Conditions
- Lung Adenocarcinoma Metastatic
- Being tested
- Crizotinib, bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crizotinib, bevacizumabDrug
Also called XALKORI,AVASTIN
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Crizotinib, bevacizumab |
| 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 Receives: Drug: Crizotinib, bevacizumab |
| 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 Receives: Drug: Crizotinib, bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 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 outcomes (3)
Overall Survival (OS)
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yihu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946359
- Sponsor's protocol ID
- CAMAR01
- Status last verified
- Nov 2016
- First submitted
- 24 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02946359
- Acronym / sponsor ID
- CAMAR01
- Conditions
- Lung Adenocarcinoma Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with ALK translocation | Experimental | Drug: Crizotinib, bevacizumabTreatment-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 | Drug: Crizotinib, bevacizumabTreatment-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 | Drug: Crizotinib, bevacizumabTreatment-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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crizotinib, bevacizumabAlso: XALKORI,AVASTINEligible 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 | Drug | Patients with ALK translocation, Patients with MET amplification, Patients with ROS1 translocation |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crizotinib, bevacizumab in people with Lung Adenocarcinoma Metastatic, run by Chinese PLA General Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.