LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: methotrexate Type: Drug
Name: afatinib Type: Drug
Overall Status
Recruiting
Summary
This randomized, open-label, phase III study will be performed in patients with recurrent and/or metastatic head and neck cancer which has progressed after platinum-based therapy. The objectives of this trial are to compare the efficacy and safety of afatinib versus methotrexate.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion criteria:

1. Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy.

2. Documented progressive disease based on investigator assessment according to RECIST, following receipt of a cisplatin and/or carboplatin based regimen administered for recurrent and/or metastatic disease independent of whether patient progressed during or after platinum based therapy.

3. Measurable disease according to RECIST (version 1.1).

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Visit 2.

5. Male and female patients age is 18 years or older

6. Signed and dated written informed consent that is in compliance with ICH-GCP and local law.

Exclusion criteria:

1. Progressive disease within three months after completion of curatively intended treatment for locoregionally advanced or for metastatic head and neck squamous cell cancer (HNSCC).

2. Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary glands.

3. Any other than one previous platinum based systemic regimen given for recurrent and/or metastatic disease. Re-challenge with the first line regimen after a temporary break is considered a second line regimen only in case of progression within the break.

4. Prior treatment with EGFR-targeted small molecules.

5. Treatment with any investigational drug or anti-cancer therapy less than four weeks prior to randomization (except palliative radiotherapy to bones to alleviate pain).

6. Unresolved chronic toxicity, other than hearing loss, tinnitus or dry mouth, CTCAE grade >2 from previous anti-cancer therapy or unresolved skin toxicities CTCAE grade >1 and/or diarrhoea CTCAE grade >1 caused by prior treatment with EGFR targeted antibodies.

7. Previous tumour bleeding CTCAE grade =3.

8. Requirement for treatment with any of the prohibited concomitant medications.

9. Major surgical or planned procedure less than four weeks prior to randomization (isolated biopsies are not considered as major surgical procedures).

10. Any other malignancy unless free of disease for at least five years except for:

1. Other HNSCC of a location as described in inclusion criterion number 1

2. Appropriately treated superficial basal cell skin cancer

3. Surgically cured cervical cancer in situ

4. For Korea: endoscopically cured superficial esophageal and/or gastric cancer is allowed

11. Known lesion or signs of brain metastasis.

12. Known pre-existing interstitial lung disease (ILD).

13. Clinically relevant cardiovascular abnormalities, as judged by the investigator, such as, but not limited to, uncontrolled hypertension, congestive heart failure NYHA classification =III, unstable angina, myocardial infarction within six months prior to randomization, or poorly controlled arrhythmia.

14. Cardiac left ventricular dysfunction with resting ejection fraction
15. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom in the opinion of the investigator, e.g. Crohn's disease, malabsorption or CTCAE grade >1 diarrhoea of any aetiology at randomization.

16. Known HIV, active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited to tuberculosis, as judged by the investigator.

17. Other significant disease that in the investigator's opinion would exclude the subject from the trial.

18. Screening laboratory values:

1. Absolute neutrophil count (ANC) <1.5x10^9/l

2. Platelet count <75x10^9/l

3. Total bilirubin >1.5 times the upper limit of normal (ULN)

4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN)

5. Calculated creatinine clearance <50 ml/min (as evidenced by using the Cockcroft-Gault formula).

19. Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or to use adequate contraception during the trial and for at least six months after end of treatment. Adequate methods of contraception and definition of child-bearing potential.

20. Pregnancy or breast feeding.

21. Known or suspected hypersensitivity to any of the study medications or their excipients.

22. Any past or present history of areca/betel-nut chewing or its derivatives for a cumulative duration of more than 3 months

23. Patients unable to comply with the protocol, in the opinion of the investigator.
Locations
1200.161.86001 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.161.86012 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.161.86015 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.161.86019 Boehringer Ingelheim Investigational Site
Beijing, China
Status: Recruiting
1200.161.86017 Boehringer Ingelheim Investigational Site
Bengbu, China
Status: Recruiting
1200.161.86014 Boehringer Ingelheim Investigational Site
Changchun, China
Status: Recruiting
1200.161.86005 Boehringer Ingelheim Investigational Site
Chengdu, China
Status: Recruiting
1200.161.86006 Boehringer Ingelheim Investigational Site
Chengdu, China
Status: Recruiting
1200.161.86016 Boehringer Ingelheim Investigational Site
Guangzhou, China
Status: Recruiting
1200.161.86013 Boehringer Ingelheim Investigational Site
Haerbin, China
Status: Recruiting
1200.161.86021 Boehringer Ingelheim Investigational Site
Hangzhou, China
Status: Recruiting
1200.161.86018 Boehringer Ingelheim Investigational Site
Nanjing, China
Status: Recruiting
1200.161.86002 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.161.86003 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.161.86008 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.161.86009 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.161.86022 Boehringer Ingelheim Investigational Site
Shanghai, China
Status: Recruiting
1200.161.86007 Boehringer Ingelheim Investigational Site
Wuhan, China
Status: Recruiting
1200.161.86010 Boehringer Ingelheim Investigational Site
Wuhan, China
Status: Recruiting
1200.161.20003 Boehringer Ingelheim Investigational Site
Alexandria, Egypt
Status: Recruiting
1200.161.20001 Boehringer Ingelheim Investigational Site
Cairo, Egypt
Status: Recruiting
1200.161.20002 Boehringer Ingelheim Investigational Site
Dakahlia, Egypt
Status: Recruiting
1200.161.85203 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
Status: Recruiting
1200.161.85201 Boehringer Ingelheim Investigational Site
Hongkong, Hong Kong
Status: Recruiting
1200.161.85202 Boehringer Ingelheim Investigational Site
Shatin, Hong Kong
Status: Recruiting
1200.161.91006 Boehringer Ingelheim Investigational Site
Amravati, India
Status: Recruiting
1200.161.91020 Boehringer Ingelheim Investigational Site
Bikaner, India
Status: Recruiting
1200.161.91019 Boehringer Ingelheim Investigational Site
Hyderabad, India
Status: Recruiting
1200.161.91023 Boehringer Ingelheim Investigational Site
Jaipur, India
Status: Not yet recruiting
1200.161.91003 Boehringer Ingelheim Investigational Site
Kolkata, West Bengal, India
Status: Recruiting
1200.161.91012 Boehringer Ingelheim Investigational Site
Lucknow, India
Status: Recruiting
1200.161.91009 Boehringer Ingelheim Investigational Site
Madurai, Tamil Nadu, India
Status: Recruiting
1200.161.91018 Boehringer Ingelheim Investigational Site
Mysore, India
Status: Recruiting
1200.161.91005 Boehringer Ingelheim Investigational Site
Nagpur, India
Status: Recruiting
1200.161.91016 Boehringer Ingelheim Investigational Site
Nasik, India
Status: Recruiting
1200.161.91008 Boehringer Ingelheim Investigational Site
Pune, India
Status: Recruiting
1200.161.91021 Boehringer Ingelheim Investigational Site
Sangli, India
Status: Not yet recruiting
1200.161.82003 Boehringer Ingelheim Investigational Site
Goyang, Korea, Republic of
Status: Recruiting
1200.161.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.161.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.161.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.161.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
1200.161.63001 Boehringer Ingelheim Investigational Site
Cebu City, Philippines
Status: Recruiting
1200.161.63002 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Status: Recruiting
1200.161.88603 Boehringer Ingelheim Investigational Site
Keelung City, Taiwan
Status: Recruiting
1200.161.88602 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
Status: Recruiting
1200.161.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Status: Recruiting
1200.161.66001 Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
Status: Recruiting
1200.161.66005 Boehringer Ingelheim Investigational Site
Muang, Thailand
Status: Not yet recruiting
1200.161.66004 Boehringer Ingelheim Investigational Site
Patumwan, Thailand
Status: Not yet recruiting
1200.161.66003 Boehringer Ingelheim Investigational Site
Phitsanulok, Thailand
Status: Recruiting
1200.161.66002 Boehringer Ingelheim Investigational Site
Songkla, Thailand
Status: Recruiting
Start Date
May 2013
Completion Date
February 2017
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page