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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


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

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Trial Information

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

Inclusion Criteria


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.

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, as determined by RECIST 1.1

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica

Study ID:

1200.125

NCT ID:

NCT01523587

Start Date:

March 2012

Completion Date:

January 2015

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell

Name

Location

1200.125.10034 Boehringer Ingelheim Investigational SiteAlhambra, California  
1200.125.10025 Boehringer Ingelheim Investigational SiteBurbank, California  
1200.125.10041 Boehringer Ingelheim Investigational SiteLa Jolla, California  
1200.125.10019 Boehringer Ingelheim Investigational SiteSacramento, California  
1200.125.10017 Boehringer Ingelheim Investigational SiteNorwalk, Connecticut  
1200.125.10058 Boehringer Ingelheim Investigational SiteSouthington, Connecticut  
1200.125.10009 Boehringer Ingelheim Investigational SiteLake City, Florida  
1200.125.10004 Boehringer Ingelheim Investigational SiteAthens, Georgia  
1200.125.10011 Boehringer Ingelheim Investigational SiteSkokie, Illinois  
1200.125.10028 Boehringer Ingelheim Investigational SiteDetroit, Michigan  
1200.125.10015 Boehringer Ingelheim Investigational SiteFresh Meadows, New York  
1200.125.10063 Boehringer Ingelheim Investigational SiteDuBois, Pennsylvania  
1200.125.10059 Boehringer Ingelheim Investigational SiteKingston, Pennsylvania  
1200.125.10016 Boehringer Ingelheim Investigational SiteSpartanburg, South Carolina  
1200.125.10055 Boehringer Ingelheim Investigational SiteParis, Texas  
1200.125.10051 Boehringer Ingelheim Investigational SiteChristianburg, Virginia  
1200.125.10052 Boehringer Ingelheim Investigational SiteSeattle, Washington  
1200.125.10073 Boehringer Ingelheim Investigational SiteChandler, Arizona  
1200.125.10039 Boehringer Ingelheim Investigational SiteCorona, California  
1200.125.10046 Boehringer Ingelheim Investigational SiteLos Angeles, California  
1200.125.10087 Boehringer Ingelheim Investigational SiteMontebello, California  
1200.125.10031 Boehringer Ingelheim Investigational SiteOrange, California  
1200.125.10002 Boehringer Ingelheim Investigational SiteRiverside, California  
1200.125.10076 Boehringer Ingelheim Investigational SiteFort Collins, Colorado  
1200.125.10085 Boehringer Ingelheim Investigational SiteStamford, Connecticut  
1200.125.10067 Boehringer Ingelheim Investigational SiteBoca Raton, Florida  
1200.125.10080 Boehringer Ingelheim Investigational SiteBrooksville, Florida  
1200.125.10066 Boehringer Ingelheim Investigational SiteHollywood, Florida  
1200.125.10027 Boehringer Ingelheim Investigational SiteLakeland, Florida  
1200.125.10081 Boehringer Ingelheim Investigational SiteNew Port Richey, Florida  
1200.125.10086 Boehringer Ingelheim Investigational SiteNew Port Richey, Florida  
1200.125.10064 Boehringer Ingelheim Investigational SiteNiles, Illinois  
1200.125.10018 Boehringer Ingelheim Investigational SiteUrbana, Illinois  
1200.125.10054 Boehringer Ingelheim Investigational SiteLafayette, Indiana  
1200.125.10032 Boehringer Ingelheim Investigational SiteLouisville, Kentucky  
1200.125.10083 Boehringer Ingelheim Investigational SiteMarrero, Louisiana  
1200.125.10048 Boehringer Ingelheim Investigational SiteBurlington, Massachusetts  
1200.125.10072 Boehringer Ingelheim Investigational SiteLawrence, Massachusetts  
1200.125.10060 Boehringer Ingelheim Investigational SiteSt. Joseph, Missouri  
1200.125.10057 Boehringer Ingelheim Investigational SiteSt. Louis, Missouri  
1200.125.10077 Boehringer Ingelheim Investigational SiteBillings, Montana  
1200.125.10069 Boehringer Ingelheim Investigational SiteBronx, New York  
1200.125.10029 Boehringer Ingelheim Investigational SiteNew York, New York  
1200.125.10062 Boehringer Ingelheim Investigational SiteSyracuse, New York  
1200.125.10024 Boehringer Ingelheim Investigational SiteCleveland, Ohio  
1200.125.10050 Boehringer Ingelheim Investigational SiteColumbus, Ohio  
1200.125.10070 Boehringer Ingelheim Investigational SiteColumbus, Ohio  
1200.125.10023 Boehringer Ingelheim Investigational SitePortland, Oregon  
1200.125.10040 Boehringer Ingelheim Investigational SitePortland, Oregon  
1200.125.10078 Boehringer Ingelheim Investigational SitePhiladelphia, Pennsylvania  
1200.125.10079 Boehringer Ingelheim Investigational SitePhiladelphia, Pennsylvania  
1200.125.10068 Boehringer Ingelheim Investigational SiteCookeville, Tennessee  
1200.125.10022 Boehringer Ingelheim Investigational SiteSan Antonio, Texas  
1200.125.10091 Boehringer Ingelheim Investigational SiteSalt Lake City, Utah  
1200.125.10061 Boehringer Ingelheim Investigational SiteBurlington, Vermont  
1200.125.10074 Boehringer Ingelheim Investigational SiteNorfolk, Virginia