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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

every 6 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

China: Food and Drug Administration

Study ID:

1200.34

NCT ID:

NCT01121393

Start Date:

April 2010

Completion Date:

May 2015

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

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