Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 96 for:    BI 695502
Previous Study | Return to List | Next Study

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

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: NCT02272413
Recruitment Status : Completed
First Posted : October 23, 2014
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 23, 2014
Results First Submitted Date  ICMJE November 15, 2019
Results First Posted Date  ICMJE January 13, 2020
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE July 8, 2015
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2019)
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: Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier. ]
ORR was defined as the percentage of patients who achieved at least one visit response of complete response (CR) or partial response (PR) after the start of treatment. The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Tumor assessments were performed prior to trial drug administration, until 18 weeks.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Best 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2019)
  • Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® [ Time Frame: From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days. ]
    The following selected adverse events (AEs) were evaluated for comparability assessment of BI 695502 and US-licensed Avastin®:
    • Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions),
    • Thromboembolic events (arterial or venous),
    • Febrile neutropenia,
    • Gastrointestinal perforations,
    • Hypertension,
    • Proteinuria,
    • Pulmonary hemorrhage,
    • Other hemorrhages (not including pulmonary hemorrhages),
    • Wound-healing complications/abscess/fistulas. The analysis of AEs was based on the concept of TEAEs. For non-switched patients, all AEs that started or worsened in severity on or after the first dose of trial drug and prior to the date of last administration of trial medication + 16 weeks inclusive were defined as TEAEs.
  • Progression-Free Survival (PFS) Time as Determined by Investigator Assessment [ Time Frame: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression. Analysis performed for pre-switch period only; maximum duration of up to 35 cycles (105 weeks). ]
    PFS was defined as the time from randomization until disease progression as determined by Investigator assessment or death from any cause, whichever occurred first during the pre-switch period. Disease progression was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters. Tumor assessments were performed prior to trial drug administration. PFS was calculated using the Kaplan-Meier technique.
  • Overall Survival (OS) Time [ Time Frame: From baseline until death due to any cause, ie., up to 35 cycles (105 weeks). ]
    OS was defined as the time randomization until death from any cause during the pre-switch period. OS was calculated using the Kaplan-Meier technique.
  • Duration of Response (DOR) as Determined by Investigator Assessment [ Time Frame: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression., ie up to 35 cycles (105 weeks). ]
    DOR was the time from first documented CR or PR until time of progression as determined by Investigator assessment during the pre-switch period. Tumor assessments were performed prior to trial drug administration. DOR was calculated using the Kaplan-Meier technique.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • 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 ]
  • 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 ]
  • 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 ]
  • Overall survival (OS) defined as the time from randomization until death from any cause. [ Time Frame: randomization until death ]
  • Duration of response defined as the time from first documented CR or PR until time of progression as per investigator assessment. [ Time Frame: from first documented CR or PR until time of progression ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
Official Title  ICMJE 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
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®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: BI 695502
  • Drug: Avastin
Study Arms  ICMJE
  • Experimental: BI 695502
    Intervention: Drug: BI 695502
  • Active Comparator: Avastin
    Intervention: Drug: Avastin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
671
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2014)
660
Actual Study Completion Date  ICMJE November 16, 2018
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Chile,   Croatia,   Egypt,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries El Salvador,   India,   Indonesia
 
Administrative Information
NCT Number  ICMJE NCT02272413
Other Study ID Numbers  ICMJE 1302.5
2014-002161-30 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP