Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
- Registration Number
- NCT02272413
- Lead Sponsor
- Boehringer Ingelheim
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 671
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 695502 BI 695502 - Avastin Avastin -
- Primary Outcome Measures
Name Time Method Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin® 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 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 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 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.
Trial Locations
- Locations (189)
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Lalita Pandit, M.D., Inc.
🇺🇸Fountain Valley, California, United States
Southern California Oncology Research Alliance
🇺🇸Los Angeles, California, United States
Innovative Clinical Research, Inc.
🇺🇸Whittier, California, United States
Ashland Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Reliant Medical Group
🇺🇸Worcester, Massachusetts, United States
Detroit Clinical Research Center
🇺🇸Owosso, Michigan, United States
Carolinas Cancer Care
🇺🇸Charlotte, North Carolina, United States
CENIT - Centro de Neurociencias, Investigacion y Tratamiento
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Scroll for more (179 remaining)Pacific Cancer Medical Center, Inc.🇺🇸Anaheim, California, United States