LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
- Registration Number
- NCT01523587
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 795
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afatinib afatinib Patients receive afatinib tablets once daily Erlotinib erlotinib Patients receive erlotinib tablets once daily
- Primary Outcome Measures
Name Time Method Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method Overall Survival From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.
Number of Participants With Objective Response According to RECIST 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Participants With Disease Control According to RECIST 1.1 First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Tumour Shrinkage First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.
A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size.
Post-baseline mean is adjusted for baseline sum of diameters and race.Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.
Summary of Time to Deterioration in Coughing, Dyspnoea and Pain. From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.
Change in Score Over Time in Coughing,Dyspnoea and Pain From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.
Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.
The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.
Trial Locations
- Locations (190)
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
University of California
🇺🇸La Jolla, California, United States
Sutter Medical Group
🇺🇸Sacramento, California, United States
Boca Raton Reginl Hospital-Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Cancer Care of North Florida, PA
🇺🇸Lake City, Florida, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Orchard Healthcare Research Inc
🇺🇸Skokie, Illinois, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
West Jefferson General Hospital and Cancer Clinic
🇺🇸Marrero, Louisiana, United States
Scroll for more (180 remaining)Ironwood Cancer and Research Centers🇺🇸Chandler, Arizona, United States