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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: afatinib Drug: erlotinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 795 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 5, 2012
Actual Primary Completion Date : October 21, 2013
Actual Study Completion Date : December 27, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Afatinib
Patients receive afatinib tablets once daily
 Drug: afatinib
Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
Active Comparator: Erlotinib
Patients receive erlotinib tablets once daily
 Drug: erlotinib
erlotinib taken once daily


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


  5. 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.

  6. 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.

  7. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523587


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] June 24, 2016
Statistical Analysis Plan  [PDF] April 18, 2012

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01523587    
Other Study ID Numbers: 1200.125
2011-002380-24 ( EudraCT Number )
First Posted: February 1, 2012    Key Record Dates
Results First Posted: November 21, 2014
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action