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
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Drug: Gemcitabine+Cisplatin
Drug: BIBW 2992
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • progression free survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 364
Study Start Date: April 2010
Estimated Study Completion Date: May 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A BIBW 2992
Patients receive a tablet of BIBW 2992 daily until progression or unacceptable toxicity
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.
Active Comparator: Arm B Chemotherapy
Patients receive Gemcitabine and Cisplatin, maximum is 6 courses
Drug: Gemcitabine+Cisplatin
Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01121393

Locations
China
1200.34.8626 Boehringer Ingelheim Investigational Site
Beijing, China
1200.34.8608 Boehringer Ingelheim Investigational Site
Beijing, China
1200.34.8609 Boehringer Ingelheim Investigational Site
Beijing, China
1200.34.8607 Boehringer Ingelheim Investigational Site
Beijing, China
1200.34.8615 Boehringer Ingelheim Investigational Site
Changchun, China
1200.34.8619 Boehringer Ingelheim Investigational Site
Changsha, China
1200.34.8618 Boehringer Ingelheim Investigational Site
Changsha, China
1200.34.8617 Boehringer Ingelheim Investigational Site
Chengdu, China
1200.34.8622 Boehringer Ingelheim Investigational Site
Fuzhou, China
1200.34.8601 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.34.8620 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.34.8631 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.34.8630 Boehringer Ingelheim Investigational Site
Haerbin, China
1200.34.8612 Boehringer Ingelheim Investigational Site
Hangzhou, China
1200.34.8616 Boehringer Ingelheim Investigational Site
HongShan, China
1200.34.8628 Boehringer Ingelheim Investigational Site
Kunming, China
1200.34.8629 Boehringer Ingelheim Investigational Site
Linyi, China
1200.34.8623 Boehringer Ingelheim Investigational Site
Nan Ning, China
1200.34.8610 Boehringer Ingelheim Investigational Site
Nanjing, China
1200.34.8611 Boehringer Ingelheim Investigational Site
Nanjing, China
1200.34.8621 Boehringer Ingelheim Investigational Site
Qingdao, China
1200.34.8627 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.34.8604 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.34.8603 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.34.8605 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.34.8602 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.34.8614 Boehringer Ingelheim Investigational Site
Shenyang, China
1200.34.8613 Boehringer Ingelheim Investigational Site
Shijiazhuang, China
1200.34.8624 Boehringer Ingelheim Investigational Site
Xi'An, China
1200.34.8632 Boehringer Ingelheim Investigational Site
Yangzhou, China
Korea, Republic of
1200.34.8203 Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
1200.34.8205 Boehringer Ingelheim Investigational Site
Cheongju, Korea, Republic of
1200.34.8204 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
1200.34.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.34.8202 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Thailand
1200.34.6601 Boehringer Ingelheim Investigational Site
Songkla, Thailand
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01121393     History of Changes
Other Study ID Numbers: 1200.34
Study First Received: April 21, 2010
Last Updated: September 3, 2014
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014