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Atezolizumab Monotherapy and Consequent Therapy With Atezolizumab Plus Bevacizumab for NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616691
Recruitment Status : Unknown
Verified August 2018 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Brief Summary:
This is a single-arm phase II trial to evaluate the efficacy and safety of atezolizumab and bevacizumab combination therapy (stage 2) after radiologic progression of atezolizumab monotherapy (stage 1) in Korean patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Initially, patients will be treated with Atezolizumab 1200mg every 3 weeks as a single agent (stage 1). After radiologic progression from atezolizumab monotherapy, patients will be consequently treated with atezolizumab (1200mg every 3 weeks) and combination with bevacizumab (15mg/kg every 3 weeks). Exploratory biomarkers will be observed in order to identify predictive biomarkers correlated to response and to evaluate the changes of local and systemic immune profile between baseline and at the time of progression.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Atezolizumab Drug: Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Single-arm Trial of Atezolizumab Monotherapy and Consequent Therapy With Atezolizumab Plus Bevacizumab in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atezolizumab
The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)
Drug: Atezolizumab
Stage I: The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)

Experimental: Atezolimab+Bevacizumab
Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy (stage 2). Both of drugs are administered via intravenous infusion every 3 weeks.
Drug: Atezolizumab
Stage I: The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)

Drug: Bevacizumab
Stage II: Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy every 3 weeks.
Other Name: Atezolizumab




Primary Outcome Measures :
  1. The primary objective for this study is to evaluate efficacy of atezolizumab with bevacizumab after radiologically progress of atezolizumab monotherapy [ Time Frame: about 36 months ]
    measured by disease control rate (DCR) per investigator using RECIST v1.1


Secondary Outcome Measures :
  1. Best overall response rate [ Time Frame: about 36 months ]
    Best overall response rate

  2. Progression-free survival [ Time Frame: about 36 months ]
    PFS, defined as the time from the first administration of atezolizumab and bevacizumab to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first

  3. Duration of response [ Time Frame: about 36 months ]
    DOR, defined as the time from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first

  4. Overall survival [ Time Frame: about 36 months ]
    OS, defined as the time from the first administration of atezolizumab and bevacizumab to death from any cause

  5. Adverse events (AEs) [ Time Frame: about 36 months ]
    Adverse events will be measured by the CTCAE scale, version 4.0



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for study entry:

  1. Signed Informed Consent Form
  2. Ability to comply with protocol
  3. 20 years old or older
  4. Histologically confirmed stage IIIb, IV or recurrent non-squamous cell NSCLC
  5. Baseline and repeat biopsy at the time of progression is mandatory. Repeat biopsy at progression to atezolizumab with bevacizumab is optional.
  6. Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g.,chemoradiation) regimen with curative intent.
  7. ECOG performance status of 0 to 1
  8. At least one measurable lesion by RECIST v1.1
  9. Patients with brain metastasis may be enrolled provided they are asymptomatic requiring no treatment, or are asymptomatic following therapy such as surgery, WBRT or SRT.
  10. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry.

  1. Prior treatment with anti-PD1 or anti-PDL1 inhibitors
  2. Patients with a known hypersensitivity to atezolizumab and/or bevacizumab or any of the excipients.
  3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  4. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells.
  5. Patients with a sensitizing EGFR mutation
  6. Patients with a previously detected ALK fusion oncogene
  7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
  8. Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease
  9. Evidence of interstitial lung disease or active, non-infectious pneumonitis
  10. Has received a live vaccine within 30 days prior to the first dose of trial treatment
  11. Has a known history of Human Immunodeficieny Virus (HIV)
  12. Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected)
  13. Surgery undertaken less than 4 weeks before the study
  14. Localized radiotherapy unless completed more than 2 weeks before the study
  15. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  16. Pregnant or breastfeeding or lactating female patients
  17. Female participants of childbearing potential will not agree to use to highly effective form(s) of contraception (i.e., one that results in a low failure rate [<1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of Atezolizumab
  18. Uncontrolled symptomatic brain metastasis
  19. Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
  20. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) Anti-hypertensive therapy to achieve these parameters is allowable.
  21. Prior history of hypertensive crisis or hypertensive encephalopathy
  22. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
  23. History of hemoptysis (>,=one-half teaspoon of bright red blood per episode) within 1 month prior to randomization
  24. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
  25. Current or recent (within 10 days of Atezolizumab administration use of aspirin (>325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol
  26. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2 weeks prior to randomization
  27. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
  28. History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to randomization
  29. Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
  30. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  31. Serious, non-healing wound, active ulcer, or untreated bone fracture
  32. Proteinuria, as demonstrated by urine dipstick or >1.0 g of protein in a 24-hour urine collection All patients with >, =2+ protein on dipstick urinalysis at baseline must undergo a 24 hour urine collection and must demonstrate > 1 g of protein in 24 hours.
  33. Clear tumor infiltration into the thoracic great vessels is seen on imaging
  34. Clear cavitation of pulmonary lesions is seen on imaging

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): NCT03616691


Contacts
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Contact: Myung-Ju Ahn, PhD 82-2-3410-3438 silk.ahn@samsung.com
Contact: hyunjung Shin 82-70-7014-6763 hjds.shin@samsung.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Myung-Ju Ahn, PhD Samsung Medical Center
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Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03616691    
Other Study ID Numbers: 2018-05-170
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Bevacizumab
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors