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LUX-Lung 5: Afatinib Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following Afatinib Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01085136
First received: March 10, 2010
Last updated: February 15, 2017
Last verified: February 2017
  Purpose
The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: Investigator´s choice of chemotherapy Drug: BIBW 2992 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression Free Survival (Part B) [ Time Frame: From randomization until disease progression or death; Up to 32 months ]

    Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy.

    Median was calculated from the Kaplan−Meier curve.



Secondary Outcome Measures:
  • Progression Free Survival (Part A) [ Time Frame: From first dose administration until disease progression or death; Up to 51 months ]

    Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A.

    Median was calculated from the Kaplan−Meier curve.


  • Overall Survival (Part B) [ Time Frame: From randomization until death; Up to 32 months ]

    Overall survival (OS) as determined by the time from randomization to death in part B.

    Median was calculated from the Kaplan−Meier curve.


  • Objective Response (Part A) [ Time Frame: Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months ]
    Objective response defined as the best overall response of complete response [CR]: disappearance of all target lesion & partial response [PR]: ≥30% decrease in the sum of the longest diameter of target lesions , taking as reference the baseline sum longest diameter of Afatinib monotherapy according to RECIST 1.1 for Part A.

  • Objective Response (Part B) [ Time Frame: Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months ]
    Objective response (CR, PR) of Afatinib/paclitaxel combination therapy and comparator chemotherapy in Part B after progression in Part A according to RECIST 1.1 .

  • Intensity and Incidence of Adverse Events (AEs) for Part A & Part B. [ Time Frame: From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B) ]
    Safety of Afatinib as indicated by intensity and incidence of adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0 both for Part A and Part B. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).


Enrollment: 1154
Study Start Date: February 2010
Study Completion Date: January 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Investigator`s choice of chemotherapy
Patients will be treated with investigator`s choice of chemotherapy
Drug: Investigator´s choice of chemotherapy
BIBW 2992 in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy
Experimental: BIBW 2992 and Paclitaxel
Patients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2
Drug: BIBW 2992
BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy

  Eligibility

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

Inclusion criteria:

Part A

  1. Patients with pathologically confirmed diagnosis of NSCLC Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa).
  2. Patients should have received and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s)) for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
  3. Patients pretreated with taxane-based chemotherapy for advanced or metastatic disease must have experienced stable disease, partial or complete response as best response
  4. Eastern Cooperative Oncology Group performance Score 0 or 1.
  5. Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as 10 mm but no less than double the slice thickness according to RESIST 1.1.
  6. Male and female patients no less than 18 years of age.
  7. Life expectancy of at least three (3) months.
  8. Written informed consent that is consistent with ICH-GCP guidelines. Part B 1) Clinical benefit (disease stabilization or antitumor response) of 12 weeks duration in Part A of the trial determined on the second tumour assessment.

2.) Patients should have progressed in Part A according to RECIST 1.1 3.) New informed consent, including consent to biomarker sampling, must be signed before patients enter Part B of the trial

Exclusion criteria:

  1. Previous treatment with BIBW 2992
  2. Chemo-, hormone- (other than megestrol acetate, steroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; except for TKI pretreatment (2 weeks only)
  3. Active/symptomatic brain metastases including leptomeningeal disease. Patients with a history of treated brain metastasis must have a stable or normal brain MRT/CT scan at screening and be at least 4 weeks post-radiation or surgery for brain metastasis. Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization.
  4. Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline
  5. Patients who have any other life-threatening 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
  6. Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer)
  7. Radiotherapy within the past 2 weeks prior to treatment with the trial drug
  8. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New york Heart Association (NYHA) functional classification of 3, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to entering the trial.
  9. Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram .
  10. Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) at or greater than 400 mg/m2
  11. Absolute neutrophil count (ANC) at or less than 1500 / mm3
  12. Platelet count at or less than 100,000 / mm3
  13. Bilirubin at or greater than 1.5 mg / dL (>26 mol / L, SI unit equivalent)
  14. Aspartate amino transferase (AST) or alanine amino transferase (ALT) at or greater than three times the upper limit of normal (if related to liver metastases at or greater than five times the upper limit of normal)
  15. Serum creatinine at or greater 1.5 times the upper normal limit or calculated/measured creatinine clearance at or less than 45 mL/min
  16. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
  17. Pregnancy or breast feeding
  18. Patients unable to comply with the protocol
  19. Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
  20. Known or suspected active drug or alcohol abuse
  21. Pre-existing or current Interstitial lung disease (ILD) 22.)
  22. Peripheral polyneuropathy of > Grade 2
  23. Requirement for treatment with any of the pohibited concomitant medication listed in section 4.2.2.1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085136

  Hide Study Locations
Locations
Argentina
Boehringer Ingelheim Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina
Australia, New South Wales
Boehringer Ingelheim Investigational Site
Kingswood, New South Wales, Australia
Australia, Queensland
Boehringer Ingelheim Investigational Site
South Brisbane, Queensland, Australia
Australia, Victoria
Boehringer Ingelheim Investigational Site
Box Hill, Victoria, Australia
Boehringer Ingelheim Investigational Site
Fitzroy, Victoria, Australia
Boehringer Ingelheim Investigational Site
Wodonga, Victoria, Australia
Austria
Boehringer Ingelheim Investigational Site
Salzburg, Austria
Belgium
Boehringer Ingelheim Investigational Site
Aalst, Belgium
Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
Boehringer Ingelheim Investigational Site
Duffel, Belgium
Boehringer Ingelheim Investigational Site
La Louvière, Belgium
Boehringer Ingelheim Investigational Site
Liège, Belgium
Boehringer Ingelheim Investigational Site
Middelheim, Belgium
Boehringer Ingelheim Investigational Site
Ottignies, Belgium
Brazil
Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
China
Boehringer Ingelheim Investigational Site
Beijing, China
Boehringer Ingelheim Investigational Site
Changchun, China
Boehringer Ingelheim Investigational Site
Chengdu, China
Boehringer Ingelheim Investigational Site
Fuzhou, China
Boehringer Ingelheim Investigational Site
Guangzhou, China
Boehringer Ingelheim Investigational Site
Hangzhou, China
Boehringer Ingelheim Investigational Site
Nanjing, China
Boehringer Ingelheim Investigational Site
Shanghai, China
Finland
Boehringer Ingelheim Investigational Site
Helsinki, Finland
France
Boehringer Ingelheim Investigational Site
Bayonne, France
Boehringer Ingelheim Investigational Site
Caen Cedex 5, France
Boehringer Ingelheim Investigational Site
Dijon, France
Boehringer Ingelheim Investigational Site
La Tronche, France
Boehringer Ingelheim Investigational Site
Lyon Cedex 08, France
Boehringer Ingelheim Investigational Site
Paris cedex 20, France
Boehringer Ingelheim Investigational Site
Paris, France
Boehringer Ingelheim Investigational Site
Saint-Herblain cedex, France
Boehringer Ingelheim Investigational Site
Villejuif Cedex, France
Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany
Boehringer Ingelheim Investigational Site
Essen, Germany
Boehringer Ingelheim Investigational Site
Esslingen, Germany
Boehringer Ingelheim Investigational Site
Gauting, Germany
Boehringer Ingelheim Investigational Site
Hamburg, Germany
Boehringer Ingelheim Investigational Site
Hannover, Germany
Boehringer Ingelheim Investigational Site
Heidelberg, Germany
Boehringer Ingelheim Investigational Site
Mainz, Germany
Boehringer Ingelheim Investigational Site
Münster, Germany
Hungary
Boehringer Ingelheim Investigational Site
Budapest, Hungary
Boehringer Ingelheim Investigational Site
Pecs, Hungary
Boehringer Ingelheim Investigational Site
Törökbálint, Hungary
India
Boehringer Ingelheim Investigational Site
Chennai, India
Boehringer Ingelheim Investigational Site
Jaipur, India
Boehringer Ingelheim Investigational Site
Maharashtra, India
Boehringer Ingelheim Investigational Site
Mumbai, India
Boehringer Ingelheim Investigational Site
Nashik, Maharashtra, India
Israel
Boehringer Ingelheim Investigational Site
Kfar Saba, Israel
Boehringer Ingelheim Investigational Site
Petach Tikva, Israel
Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
Italy
Boehringer Ingelheim Investigational Site
Avellino, Italy
Boehringer Ingelheim Investigational Site
Aviano (PN), Italy
Boehringer Ingelheim Investigational Site
Bergamo, Italy
Boehringer Ingelheim Investigational Site
Genova, Italy
Boehringer Ingelheim Investigational Site
Milano, Italy
Boehringer Ingelheim Investigational Site
Monza (mi), Italy
Boehringer Ingelheim Investigational Site
Ravenna, Italy
Boehringer Ingelheim Investigational Site
Roma, Italy
Korea, Republic of
Boehringer Ingelheim Investigational Site
Goyang, Korea, Republic of
Boehringer Ingelheim Investigational Site
Hwasun, Korea, Republic of
Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Mexico
Boehringer Ingelheim Investigational Site
Distrito Federal, Mexico
Netherlands
Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
Peru
Boehringer Ingelheim Investigational Site
Arequipa, Peru
Boehringer Ingelheim Investigational Site
La Victoria, Peru
Poland
Boehringer Ingelheim Investigational Site
Gdansk, Poland
Boehringer Ingelheim Investigational Site
Olsztyn, Poland
Boehringer Ingelheim Investigational Site
Otwock, Poland
Boehringer Ingelheim Investigational Site
Warszawa, Poland
Russian Federation
Boehringer Ingelheim Investigational Site
Obninsk, Russian Federation
Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Spain
Boehringer Ingelheim Investigational Site
A Coruña, Spain
Boehringer Ingelheim Investigational Site
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Boehringer Ingelheim Investigational Site
Mataró, Spain
Boehringer Ingelheim Investigational Site
Málaga, Spain
Boehringer Ingelheim Investigational Site
Valencia, Spain
Taiwan
Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Boehringer Ingelheim Investigational Site
Tainan, Taiwan
Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Boehringer Ingelheim Investigational Site
Taoyuan, Taiwan
Ukraine
Boehringer Ingelheim Investigational Site
Dnipropetrovks, Ukraine
Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
United Kingdom
Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
Boehringer Ingelheim Investigational Site
Dundee, United Kingdom
Boehringer Ingelheim Investigational Site
Exeter, United Kingdom
Boehringer Ingelheim Investigational Site
London, United Kingdom
Boehringer Ingelheim Investigational Site
Maidstone, United Kingdom
Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Boehringer Ingelheim Investigational Site
Sutton, Surrey, United Kingdom
Boehringer Ingelheim Investigational Site
Truro, Cornwall, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01085136     History of Changes
Other Study ID Numbers: 1200.42
2009-014563-39 ( EudraCT Number: EudraCT )
Study First Received: March 10, 2010
Results First Received: October 1, 2014
Last Updated: February 15, 2017

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Gefitinib
Albumin-Bound Paclitaxel
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017