BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
- Conditions
- Carcinoma, Non-Small-Cell LungAdenocarcinoma
- Interventions
- Registration Number
- NCT00949650
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIBW 2992 BIBW 2992 BIBW 2992 tablet once daily until progression Cisplatin/Pemetrexed Pemetrexed Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles Cisplatin/Pemetrexed Cisplatin Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Time Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Objective Response (OR) Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.
Percentage of Participants With Disease Control (DC) Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.
Overall Survival (OS) Time From randomisation to cut-off date (17MAR2017). OS was defined as time from randomisation to death.
Tumour Shrinkage Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.
Change From Baseline in Body Weight Baseline and throughout the trial until progression (every 3 weeks), up to 28 months. Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Throughout the trial until progression (every 3 weeks), up to 28 months. ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.
1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.
2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.
3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.
4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair.
5. Dead.Trough Plasma Concentrations of Afatinib at Day 22 Day 22. Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Trough Plasma Concentrations of Afatinib at Day 43 Day 43. Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing Throughout the trial until progression (every 3 weeks). HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
HRQOL: Time to Deterioration in Dyspnoea Throughout the trial until progression (every 3 weeks). HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Trough Plasma Concentrations of Afatinib at Day 29 Day 29. Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
HRQOL: Time to Deterioration in Pain Throughout the trial until progression (every 3 weeks). HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.
Trial Locations
- Locations (132)
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Clinical Trials and Research Associates Inc
🇺🇸Montebello, California, United States
Innovative Medical Research of South Florida
🇺🇸Miami, Florida, United States
Crescent City Research Consortiom
🇺🇸Marrero, Louisiana, United States
Interlakes Foundation, Incorporated
🇺🇸Rochester, New York, United States
Lehigh Valley Hospital / Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
South Texas Institute of Cancer, Northwest Cancer Center
🇺🇸Corpus Christi, Texas, United States
Instituto de Medicina Nuclear de Bahía Blanca
🇦🇷Bahía Blanca, Argentina
Hospital Alemán
🇦🇷Capital Federal, Argentina
Imcaba S.R.L.
🇦🇷Capital Federal, Argentina
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