BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01121393
First received: April 21, 2010
Last updated: September 3, 2014
Last verified: September 2014

April 21, 2010
September 3, 2014
April 2010
December 2013   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01121393 on ClinicalTrials.gov Archive Site
  • Complete Response, Partial Response, Stable Disease, Progressive Disease according to RECIST1.1 [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • deterioration of body weight and ECOG performance status [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • score change of questionnaires health-related quality of life [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • safety of BIBW 2992 as indicated by intensity and incidence of adverse events [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of BIBW 2992 [ Time Frame: day 1, 8 of cycle 2, day 1 of cycle 3 ] [ Designated as safety issue: No ]
  • Complete Response, Partial Response, Stable Disease, Progressive Disease according to RECIST1.1 [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • deterioration of body weight and ECOG performance status [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • score change of questionnaires health-related quality of life [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
  • pharmacokinetics of BIBW 2992(detect the valley concentration of BIBW 2992) [ Time Frame: Day 1,8 of Cycle 2, Day1 of Cycle 3 ] [ Designated as safety issue: No ]
  • safety of BIBW 2992 as indicated by intensity and incidence of adverse events [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation

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
  • Adenocarcinoma
  • Drug: Gemcitabine+Cisplatin
    Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.
  • Drug: BIBW 2992
    starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related AE, dose reduction will be increments of 10 mg, with the lowest dose being 20mg.
  • Experimental: Arm A BIBW 2992
    Patients receive a tablet of BIBW 2992 daily until progression or unacceptable toxicity
    Intervention: Drug: BIBW 2992
  • Active Comparator: Arm B Chemotherapy
    Patients receive Gemcitabine and Cisplatin, maximum is 6 courses
    Intervention: Drug: Gemcitabine+Cisplatin
Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
364
May 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. pathologically confirmed diagnosis of stage IIIB or stage IV adenocarcinoma of the Lung
  2. EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory analysis of tumor biopsy material
  3. Measurable disease according to RECIST1.1
  4. ECOG(Eastern Cooperative Oncology Group) score of 0 or 1.
  5. Age>=18 years
  6. life expectancy of at least three months
  7. Written informed consent that is consistent with ICH-GCP guidelines.

Exclusion criteria:

  1. Prior chemotherapy for relapsed and/or metastatic NSCLC.
  2. Prior treatment with EGFR targeting small molecules or antibodies.
  3. Radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization
  4. Active brain metastases
  5. Any other current malignancy or malignancy diagnosed within the past 5 years
  6. Known pre-existing interstitial lung disease
  7. Significant or recent acute gastrointestinal disorders with diarrhoea as a a major symptoms.
  8. History or presence of clinically relevant cardiovascular abnormalities
  9. Cardiac left ventricular function with resting ejection fraction of less than 50%.
  10. 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.
  11. Absolute neutrophil count(ANC)<1500/mm3
  12. Platelet count<100,000/mm3
  13. Creatinine clearance<60ml/min or serum creatinine>1.5 times ULN(upper limiter of number).
  14. Bilirubin>1.5 times ULN
  15. AST(Aspartate Amino Transferase) or ALT(Alanine Amino Transferase) > 3 times ULN
  16. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
  17. Pregnancy of breast-feeding
  18. Patients unable to comply with the protocol
  19. Active hepatitis B infection, active hepatitis C infection or known HIV(Human Immunodeficiency Virus) carrier.
  20. Known or suspected active drug or alcohol abuse.
  21. requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2
  22. Any contraindications for therapy with gemcitabine/cisplatin
  23. Known hypersensitivity to BIBW2992 or the excipient of any of the trial drugs
  24. Use of any investigational drug within 4 weeks of randomization.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Thailand
 
NCT01121393
1200.34
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
September 2014

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