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Trial record 1 of 78 for:    BI 695502
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Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer

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ClinicalTrials.gov Identifier: NCT02272413
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: BI 695502 Drug: Avastin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 8, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : November 16, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 695502 Drug: BI 695502
Active Comparator: Avastin Drug: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. Best overall Response rate (ORR) based on unconfirmed response assessment as assessed by central imaging review until 18 weeks after the start of treatment. [ Time Frame: randomization until 18 weeks ]

Secondary Outcome Measures :
  1. The proportion of patients with the especially selected adverse events for comparability assessment of BI 695502 and Avastin: Gastrointestinal perforations, Hypertension, Proteinuria, Pulmonary hemorrhage [ Time Frame: randomization until end of Safety follow up ]
  2. The proportion of patients with the especially selected adverse events for comparability assessment of BI 695502 and Avastin: Other hemorrhages, Wound-healing complications/abscess/fistulas [ Time Frame: randomization until end of Safety follow up ]
  3. Progression-free survival (PFS) defined as the time from randomization until disease progression as per investigator assessment or death. [ Time Frame: randomization until disease progression or death ]
  4. Overall survival (OS) defined as the time from randomization until death from any cause. [ Time Frame: randomization until death ]
  5. Proportion of patients with the especially selected adverse events (AEs) for comparability assessment of BI 695502 and Avastin®: Anaphylactic, Hypersensitivity, infusion-related reactions, arterial and venous thromboembolic events, febrile neutropenia [ Time Frame: randomization until end of Safety follow up ]
  6. Duration of response defined as the time from first documented complete response (CR) plus partial response (PR) until time of progression as per investigator assessment. [ Time Frame: from first documented CR or PR until time of progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT02272413


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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02272413     History of Changes
Other Study ID Numbers: 1302.5
2014-002161-30 ( EudraCT Number )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors