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



Status:Completed
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/28/2018
Start Date:July 8, 2015
End Date:November 16, 2018

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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
10
sites
Owosso, Michigan 48867
1914
mi
from 91732
Owosso, MI
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Anaheim, California 92801
16
mi
from 91732
Anaheim, CA
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Ashland, Kentucky 41101
1981
mi
from 91732
Ashland, KY
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Bakersfield, California 93309
105
mi
from 91732
Bakersfield, CA
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411 Billingsley Road
Charlotte, North Carolina 28204
2104
mi
from 91732
Charlotte, NC
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?
mi
from 91732
Ciudad Autonoma Buenos Aires,
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Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
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Los Angeles, California 90057
13
mi
from 91732
Los Angeles, CA
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Whittier, California 90603
8
mi
from 91732
Whittier, CA
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Worcester, Massachusetts 01608
2540
mi
from 91732
Worcester, MA
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