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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01523587
First received: January 30, 2012
Last updated: November 20, 2014
Last verified: November 2014

January 30, 2012
November 20, 2014
March 2012
October 2013   (final data collection date for primary outcome measure)
Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1 [ Time Frame: First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks). ] [ Designated as safety issue: No ]
The primary endpoint of this study was Progression Free Survival (PFS), as determined by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. PFS was defined as the time from randomisation to disease progression (or death if the patient died before progression).
Progression-free survival, as determined by RECIST 1.1 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01523587 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: From randomisation until 632 deaths ] [ Designated as safety issue: No ]

    The primary analysis of Overall Survival (OS) will be conducted after 632 deaths have occured. This is predicted to be March 2015.

    Overall Survival is defined as the time from randomisation to death.

  • Objective Response According to RECIST 1.1 [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ] [ Designated as safety issue: No ]
    Objective response as defined by RECIST 1.1 as either complete response (CR) or partial response (PR).
  • Disease Control According to RECIST 1.1 [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ] [ Designated as safety issue: No ]
    Disease control (defined as CR, PR or Stable Disease (SD)) according to RECIST 1.1.
  • Tumour Shrinkage [ Time Frame: First treatment administration until cut off date of 7th October 2013 (up to 78 weeks). ] [ Designated as safety issue: No ]

    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.

  • Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire [ Time Frame: First treatment administration up to 28 days after the last intake of study medication. ] [ Designated as safety issue: No ]

    Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC 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 EOT and follow up prior to clinical assessment. The results displayed show 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 proportion 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: First treatment administration up to 28 days after the last intake of study medication. ] [ Designated as safety issue: No ]
    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: First treatment administration up to 28 days after last intake of study medication ] [ Designated as safety issue: No ]

    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).

Overall Survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: afatinib
    Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
  • Drug: erlotinib
    erlotinib taken once daily
  • Experimental: Afatinib
    Patients receive afatinib tablets once daily
    Intervention: Drug: afatinib
  • Active Comparator: Erlotinib
    Patients receive erlotinib tablets once daily
    Intervention: Drug: erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
795
November 2015
October 2013   (final data collection date for primary outcome measure)

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 ICH-GCP guidelines.

Exclusion criteria:

  1. Prior treatment with 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT01523587
1200.125, 2011-002380-24
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2014

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