Non-small Cell Lung CancerBevMarNCT02195336
dMR During First Line Treatment of Non Squamous Lung Cancer: Time Course and Prognostic and Predictive Impact.
A study testing dMRT, Bevacizumab and paclitaxel and carboplatin in people with Non-small Cell Lung Cancer, run by Karl Kölbeck at 1 site in Sweden.
Trial summary
To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- dMRT, Bevacizumab and paclitaxel and carboplatin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-specific procedure
- Age ≥18 years
- Able to comply with the protocol
- Histologically or cytologically documented inoperable, metastatic (Stage IV) non small cell lung cancer
- ECOG PS status 0-1
- Life expectancy ≥12 weeks
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- Adequate haematological function:
- Normal values of absolute neutrophil and platelet count, and a hemoglobin value ≥9 g/dL
- Adequate liver function:
- Total bilirubin <1.5 x ULN, AST, ALT <2.5 x ULN
- Adequate renal function:
- Calculated creatinine clearance ≥50 mL/min, a urine dipstick for proteinuria <2+.
- Normal values of INR within 7 days prior to enrolment
- If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study.
Who cannot join
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
- Known EGFR mutation or ALK translocation
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava)
- Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
- Previous treatment with chemotherapy or other anticancer agent
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- Previous radiotherapy of the primary tumour. Palliative extrathoracic radiotherapy is allowed prior to enrolment or during treatment
- Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325mg/day) or use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)
- Clinically significant (i.e. active) cardiovascular disease
- Non-healing wound, active peptic ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, means of contraception during the study and for a period of 6 months following the last administration of bevacizumab. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of bevacizumab. Men who do not agree to use effective contraception during the study and for a period of 90 days following the last administration of bevacizumab
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies
- Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
- Patients diagnosed with a tracheo-oesophageal fistula
- History of thrombotic disorders within the last 6 months prior to enrolment.
- Contraindications for MRI: pacemaker and/or non-MRI compatible metallic implants/objects/devices/fragments.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Lung and Allergy, Karolinska university hospital
Stockholm
Karl-Gustav Kölbeck, MD, +46-8-51774960, karl.kolbeck@karolinska.se
Eeva Alamartimo, RN, +46-8-51773918, eeva.alamartimo@ki.se
About this study
Official title: Diffusion MR (dMRT) During First Line Treatment of Non Squamous Lung Cancer With Chemotherapy Combined With Bevacizumab: Time Course and Prognostic and Predictive Impact.
To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced NSCLC.
Recent data are suggestive of a predictive value of imaging techniques for early detection of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no presented data available on correlation between changes in diffusion-weighted MR and response to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to prospectively investigate changes in MR variables during treatment with bevacizumab and to detect signals of prognostic and/or predictive value of MR changes during treatment.
Read the detailed description
A Non Interventional, open-label, single arm, single institution pilot study. Eligible patients will be monitored by diffusion-weighted magnetic resonance tomography (dMRT) during treatment with bevacizumab + chemotherapy for up to four cycles followed by bevacizumab maintenance therapy until disease progression.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- dMRT, Bevacizumab, paclitaxel and carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dMRTDevice
Also called Magnetic Resonance Tomograph
Baseline, day 8, day 28, day 92, progression/relapse.
BevacizumabDrug
Also called Avastin
7.5mg/kg every 3 weeks for 3 cycles. Thereafter every 3 weeks until progression/relapse or unacceptable toxicity.
paclitaxel and carboplatinDrug
Standard of care NSCLC first-line chemotherapy Every 3 weeks for 3 cycles. Doublets containing paclitaxel and carboplatin are preferred
| Study group | Role | What they receive |
|---|---|---|
| dMRT, Bevacizumab, Chemotherapy | Experimental | dMRT: Magnetic Resonance Tomograph, Baseline, day 8, day 28, day 92, progression/relapse.
Bevacizumab: 7.5mg/kg every 3 weeks for 3 cycles. Standard of care NSCLC first-line chemotherapy, doublets containing paclitaxel and carboplatin are preferred, every 3 weeks for 3 cycles.
Thereafter Bevacizumab 7.5mg/kg every 3 weeks until progression/relapse or unacceptable toxicity. Receives: Device: dMRT; Drug: Bevacizumab; Drug: paclitaxel and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
dMRT changes during treatment
Diffusion magnetic resonance tomography of lung lesions.
Measured: Baseline, Day 8, Day 28, Day 92, At relapse.
Secondary outcomes (3)
Response to treatment
CT of lungs, clinical examinations
Measured: Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up
3. Time to disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression)
CT, clinical examinations
Measured: Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up
Duration of survival
Defined as the time period from the start of first-line therapy to death.
Measured: At 5, 7, 9, 12, 15, 18, 24, 36 and 48 mo during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Kölbeck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karl Kölbeck, Karolinska University Hospital
- Investigators
- Karl-Gustav Kölbeck, MD, Principal investigator, Karolinska University Hospital, Dept of Lung and Allergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195336
- Sponsor's protocol ID
- BevMar
- Other IDs
- ML29273
- Acronym
- BevMar
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion MR (dMRT) During First Line Treatment of Non Squamous Lung Cancer With Chemotherapy Combined With Bevacizumab: Time Course and Prognostic and Predictive Impact.
- ClinicalTrials.gov ID
- NCT02195336
- Acronym / sponsor ID
- BevMar / BevMar
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karl KölbeckUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Jul 2014 (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.
To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced NSCLC.
Recent data are suggestive of a predictive value of imaging techniques for early detection of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no presented data available on correlation between changes in diffusion-weighted MR and response to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to prospectively investigate changes in MR variables during treatment with bevacizumab and to detect signals of prognostic and/or predictive value of MR changes during treatment.
Detailed description
A Non Interventional, open-label, single arm, single institution pilot study. Eligible patients will be monitored by diffusion-weighted magnetic resonance tomography (dMRT) during treatment with bevacizumab + chemotherapy for up to four cycles followed by bevacizumab maintenance therapy until disease progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dMRT, Bevacizumab, Chemotherapy | Experimental | Device: dMRT, Drug: Bevacizumab, Drug: paclitaxel and carboplatindMRT: Magnetic Resonance Tomograph, Baseline, day 8, day 28, day 92, progression/relapse. Bevacizumab: 7.5mg/kg every 3 weeks for 3 cycles. Standard of care NSCLC first-line chemotherapy, doublets containing paclitaxel and carboplatin are preferred, every 3 weeks for 3 cycles. Thereafter Bevacizumab 7.5mg/kg every 3 weeks until progression/relapse or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent obtained prior to any study-specific procedure
- Age ≥18 years
- Able to comply with the protocol
- Histologically or cytologically documented inoperable, metastatic (Stage IV) non small cell lung cancer
- ECOG PS status 0-1
Key exclusion criteria (22 listed)
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
- Known EGFR mutation or ALK translocation
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava)
- Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS 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 |
|---|---|---|
| dMRTAlso: Magnetic Resonance TomographBaseline, day 8, day 28, day 92, progression/relapse. | Device | dMRT, Bevacizumab, Chemotherapy |
| BevacizumabAlso: Avastin7.5mg/kg every 3 weeks for 3 cycles. Thereafter every 3 weeks until progression/relapse or unacceptable toxicity. | Drug | dMRT, Bevacizumab, Chemotherapy |
| paclitaxel and carboplatinStandard of care NSCLC first-line chemotherapy Every 3 weeks for 3 cycles. Doublets containing paclitaxel and carboplatin are preferred | Drug | dMRT, Bevacizumab, Chemotherapy |
Primary outcome
dMRT changes during treatment
Time frame: Baseline, Day 8, Day 28, Day 92, At relapse.
Diffusion magnetic resonance tomography of lung lesions.
3 secondary outcomes
Response to treatment
Time frame: Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up
3. Time to disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression)
Time frame: Baseline, Day 92, at 5, 7, 9, 12, 15, 18, 24 mo during follow up
Duration of survival
Time frame: At 5, 7, 9, 12, 15, 18, 24, 36 and 48 mo during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
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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.
Karl-Gustav Kölbeck, MD principal investigator
Karolinska University Hospital, Dept of Lung and Allergy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dMRT, Bevacizumab and paclitaxel and carboplatin in people with Non-small Cell Lung Cancer, run by Karl Kölbeck at 1 site in Sweden.
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 14 inclusion and 22 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 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
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?
Contact Karl-Gustav Kölbeck, MD (+46-8-51774960, karl.kolbeck@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dMRT changes during treatment (time frame: Baseline, Day 8, Day 28, Day 92, At relapse.). 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 21 Jul 2014.