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Study Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer (BEVERLY)

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ClinicalTrials.gov Identifier: NCT02633189
Recruitment Status : Unknown
Verified July 2017 by National Cancer Institute, Naples.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:
The purpose of this study is to test whether the combination of bevacizumab and erlotinib can prolong progression free survival as compared with erlotinib alone as first-line treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR.

Condition or disease Intervention/treatment Phase
Non-squamous Non-small Cell Lung Cancer Drug: Erlotinib Drug: Bevacizumab Phase 3

Detailed Description:
The co-primary objectives are to assess investigator-assess, and blinded independent centrally-reviewed progression-free survival .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open-label Phase 3 Trial Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: erlotinib and bevacizumab Drug: Erlotinib
given orally 150 mg daily

Drug: Bevacizumab
15 mg/kg intravenously every 21 days.

Active Comparator: erlotinib Drug: Erlotinib
given orally 150 mg daily




Primary Outcome Measures :
  1. progression free survival [ Time Frame: up to 2 years ]
    as determined by investigator

  2. progression free survival [ Time Frame: up to 2 years ]
    as determined by an independent central review board blinded to study treatment


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]
  2. changes in quality of life scores from baseline [ Time Frame: up to 2 years ]
  3. number of patients with complete and partial responses , investigator assessed [ Time Frame: 6 months ]
  4. number of patients with complete and partial responses , centrally reviewed [ Time Frame: 6 months ]
  5. worst grade toxicity per patient [ Time Frame: up to one year ]
  6. progression free survival according to type of EGFR mutation (exon 19del, exon 21L858R, other) [ Time Frame: 2 years ]

Other Outcome Measures:
  1. number and type of EGFR mutations in plasma samples [ Time Frame: up to 2 years ]
    samples taken at baseline, 6 weeks, 6 months, and at progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Histological documentation of primary non squamous lung carcinoma
  3. Stage IV or IIIB disease with supraclavicular metastatic nodes (according to TNM 7th edition)
  4. Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations, such as exon 21 L861Q, exon 18 G719S, G719A and G719C, exon 20 S768I and V769L). EGFR mutation testing must be performed at participating centres in a certified lab (AIOM-SIAPEC program or other European Quality Assurance [EQA] schemes)
  5. Clinical or radiologic evidence of disease (at least one target or non target lesion according to RECIST 1.1)
  6. ECOG performance status 0 to 2
  7. Life expectancy > 3 months
  8. Use of an acceptable mean of contraception for men and women of childbearing potential
  9. Written informed consent.

Exclusion Criteria:

  1. EGFR T790M mutation alone or exon 20 insertions as unique mutation
  2. Tumors with a squamous component
  3. Prior chemotherapy or any other medical treatment for advanced NSCLC (previous neoadjuvant or adjuvant chemotherapy is allowed if > 6 months before randomisation)
  4. Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if ≥ 14 days before randomization)
  5. Full-dose anticoagulation with warfarin
  6. Current or recent (within 10 days of enrolment) use of aspirin (>325 mg/day) or chronic use of other full-dose nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-platelet activity
  7. Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP3A4) are prohibited =< 7 days prior to registration
  8. Receiving any medications or substances that are inducers of CYP3A4 use of inducers are prohibited =< 7 days prior to registration
  9. Inadequate coagulation parameters:

    • activated partial thromboplastin time (APTT) >1.5 x the upper limit of normal (ULN) or
    • INR >1.5
  10. Inadequate liver function, defined as:

    • serum (total) bilirubin >1.5 x ULN
    • AST/SGOT or ALT/SGPT >2.5 x ULN
  11. Inadequate renal function, defined as:

    • serum creatinine >2.0 mg/dl or >177 micromol/l
    • urine dipstick for proteinuria >2+. Patients with > o = 1+ proteinuria at baseline dipstick analysis must undergo a 24-hour urine collection and must demonstrate ≤1g of protein in their 24-hour urine collection.
  12. Pregnancy or breast-feeding
  13. Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure >100 mmHg on antihypertensive medications)
  14. History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
  15. History of any of the following within 6 months prior to randomisation: serious systemic disease, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  16. Serious, non-healing wound, ulcer, or bone fracture
  17. Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
  18. Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
  19. In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
  20. Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
  21. Anticipation of need for a major surgical procedure during the course of the study
  22. Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
  23. Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or his/her ability to comply with study requirements
  24. Any other invasive malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA)
  25. Brain metastasis
  26. Patients who have had radiotherapy ≥ 4 weeks prior to the first dose of study treatment, but who are still experiencing acute toxic effects of radiotherapy
  27. Known HIV positive patients (patients with both acute or chronic infection are excluded)
  28. Active HBV or HCV infection (patients with chronic non-active infection are eligible)
  29. Any already known inflammatory changes of the surface of the eye at baseline
  30. Any other concomitant pathologies or laboratory alterations that prevent or contraindicate the use of erlotinib or bevacizumab.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633189


Contacts
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Contact: Francesco Perrone, M.D. +39 081 5903522 f.perrone@istitutotumori.na.it
Contact: Maria Carmela Piccirillo, M.D. +39 081 5903571 m.piccirillo@istitutotumori.na.it

  Show 55 Study Locations
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Cesare Gridelli, M.D. S.G.Moscati Hospital

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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT02633189     History of Changes
Other Study ID Numbers: BEVERLY
2015-002235-17 ( EudraCT Number )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Keywords provided by National Cancer Institute, Naples:
stage IV
stage IIIB
EGFR mutation
non-squamous
liquid biopsy
erlotinib
bevacizumab
Additional relevant MeSH terms:
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Bevacizumab
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action