dMR During First Line Treatment of Non Squamous Lung Cancer: Time Course and Prognostic and Predictive Impact.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02195336
• Date of registration: 14/07/2014
• Prospective Registration: Yes
• Primary sponsor: Karl Kölbeck
• Public title: dMR During First Line Treatment of Non Squamous Lung Cancer: Time Course and Prognostic and Predictive Impact. BevMar
• Scientific 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.
• Date of first enrolment: August 2014
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02195336
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Karl-Gustav Kölbeck, MD

• Name: Karl-Gustav Kölbeck, MD

• Name: Karl-Gustav Kölbeck, MD
• Affiliation: Karolinska University Hospital, Dept of Lung and Allergy

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent obtained prior to any study-specific procedure

2. Age =18 years

3. Able to comply with the protocol

4. Histologically or cytologically documented inoperable, metastatic (Stage IV) non
small cell lung cancer

5. ECOG PS status 0-1

6. Life expectancy =12 weeks

7. Adequate haematological function:

- Normal values of absolute neutrophil and platelet count, and a hemoglobin value
=9 g/dL

8. Adequate liver function:

- Total bilirubin <1.5 x ULN, AST, ALT <2.5 x ULN

9. Adequate renal function:

- Calculated creatinine clearance =50 mL/min, a urine dipstick for proteinuria
<2+.

10. Normal values of INR within 7 days prior to enrolment

11. 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.

Exclusion Criteria:

1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a
predominant squamous component

2. Known EGFR mutation or ALK translocation

3. History of haemoptysis

4. 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)

5. 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

6. Previous treatment with chemotherapy or other anticancer agent

7. Previous radiotherapy of the primary tumour. Palliative extrathoracic radiotherapy
is allowed prior to enrolment or during treatment

8. 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

9. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior
to the first bevacizumab infusion

10. 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.

11. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
bleeding

12. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)

13. Clinically significant (i.e. active) cardiovascular disease

14. Non-healing wound, active peptic ulcer or bone fracture

15. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months of enrolment

16. 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

17. Treatment with any other investigational agent, or participation in another clinical
trial within 28 days prior to enrolment

18. Known hypersensitivity to bevacizumab or any of its excipients, and any of the
chemotherapies

19. 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

20. Patients diagnosed with a tracheo-oesophageal fistula

21. History of thrombotic disorders within the last 6 months prior to enrolment.

22. Contraindications for MRI: pacemaker and/or non-MRI compatible metallic
implants/objects/devices/fragments.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Intervention(s)

Drug: paclitaxel and carboplatin

Drug: Bevacizumab

Device: dMRT

Primary Outcome(s)

dMRT changes during treatment [Time Frame: Baseline, Day 8, Day 28, Day 92, At relapse.]

Secondary Outcome(s)

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]

Response to treatment [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]

Secondary ID(s)

BevMar

ML29273

Source(s) of Monetary Support

Please refer to primary and secondary sponsors