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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

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ClinicalTrials.gov Identifier: NCT01523587
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : November 21, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 1, 2012
Results First Submitted Date  ICMJE October 6, 2014
Results First Posted Date  ICMJE November 21, 2014
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE March 5, 2012
Actual Primary Completion Date October 21, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
Progression-free survival, as determined by RECIST 1.1 [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Overall Survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
Overall Survival [ Time Frame: up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: afatinib
    Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
  • Drug: erlotinib
    erlotinib taken once daily
Study Arms  ICMJE
  • Experimental: Afatinib
    Patients receive afatinib tablets once daily
    Intervention: Drug: afatinib
  • Active Comparator: Erlotinib
    Patients receive erlotinib tablets once daily
    Intervention: Drug: erlotinib
Publications *

*   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: February 19, 2014)
795
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
800
Actual Study Completion Date  ICMJE December 27, 2017
Actual Primary Completion Date October 21, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diagnosis of advanced stage NSCLC squamous histology.
  2. Platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC.
  3. Eligible to receive 2nd line therapy in the opinion of the investigator.
  4. Measurable disease according to RECIST 1.1.
  5. Adequate Performance Status.
  6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable.
  7. Adequate organ function.
  8. Age = 18 years and above.
  9. Written informed consent that is consistent with International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines.

Exclusion criteria:

  1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) directed small molecules or antibodies.
  2. Radiotherapy within 4 weeks prior to randomization.
  3. Active brain metastases .
  4. Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer).
  5. Known pre-existing interstitial lung disease.
  6. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom
  7. Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
  8. Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
  9. Female patients of childbearing potential (see Section 4.2.3.3) who:

    1. are nursing or
    2. are pregnant or
    3. are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and/or do not agree to submit to pregnancy testing required by this protocol.
  10. Active hepatitis B infection (defined as presence of Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
  11. Known or suspected active drug or alcohol abuse in the opinion of the investigator.
  12. Any contraindications for therapy with afatinib or erlotinib.
  13. Known hypersensitivity to erlotinib, afatinib or the excipients of any of the trial drugs.
  14. Major surgery within 4 weeks of starting study treatment.
  15. Prior participation in an afatinib clinical study, even if not assigned to afatinib.
  16. Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product).
  17. Patients without Progression of their lung cancer.
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,   Austria,   Canada,   Chile,   China,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Portugal,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Peru
 
Administrative Information
NCT Number  ICMJE NCT01523587
Other Study ID Numbers  ICMJE 1200.125
2011-002380-24 ( 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 February 2019

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