Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/29/2017
Start Date:July 8, 2015
End Date:March 30, 2019

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A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

The objective of this phase III trial is to establish statistical equivalence in terms of
efficacy (best overall response rate [ORR], proportion of patients with complete response
[CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus
chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with
either BI 695502 or Avastin®.


Inclusion criteria:

Adult patients aged >=18 years with histologically or cytologically confirmed advanced
nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized
according to the predominant histology.

Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV)
with an indication for therapy with paclitaxel + carboplatin + Avastin®.

Patients harboring tumors with unknown or without activating epidermal growth factor
receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe
included provided chemotherapy is standard of care. At least one measurable lesion
according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent
central review.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Adequate hepatic, renal, and bone marrow function:

Life expectancy > 6 months based on clinical judgment. Further inclusion criteria apply.

Exclusion criteria:

Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular
Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.

Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or
radiotherapy for locally advanced nsNSCLC if completed <12 months prior to Screening.

Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of
the skin or pre-invasive cancer of the cervix.

Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cell
carcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS).

Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous
anticancer therapy (including radiotherapy).

History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
bleeding. Thrombotic or hemorrhagic event =< 6 months prior to Screening. Further exclusion
criteria apply.
We found this trial at
9
sites
Anaheim, California 92801
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Anaheim, CA
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Ashland, Kentucky 41101
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Ashland, KY
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Bakersfield, California 93309
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Bakersfield, CA
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411 Billingsley Road
Charlotte, North Carolina 28204
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Charlotte, NC
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Ciudad Autonoma Buenos Aires,
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Los Angeles, California 90057
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from
Los Angeles, CA
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Owosso, Michigan 48867
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Owosso, MI
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Whittier, California 90603
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from
Whittier, CA
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Worcester, Massachusetts 01608
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from
Worcester, MA
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