Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
LUX-Lung EAP US; An Open Label Expanded Access Program of Afatinib (BIBW 2992) for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Verified date | March 2015 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Expanded Access |
This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in advanced NSCLC patients who harbor an EGFR mutation.
Status | Approved for marketing |
Enrollment | 0 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: Patients with: 1. locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) 2. Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology. 3. male or female patients age >=18 years 4. Adequate organ function, defined as all of the following: 1. Left Ventricular Ejection Fraction (LVEF) >50% or within institution normal values 2. Absolute Neutrophil Count (ANC) > 1500/mm3. 3. Platelet count >75,000/mm3 4. Serum creatinine < 1.5 times of the upper limit of normal 5. Total Bilirubin < 1.5 times upper limit of (institutional) normal. 6. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN). 5. ECOG score between 0 - 2 6. written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law. Exclusion criteria: Patients who or with: 1. hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted) 2. Radiotherapy within 14 days prior to drug administration, except as follows: 1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and 2. Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling. 3. major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial 4. known hypersensitivity to afatinib or any of its excipients 5. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the treating physician. Myocardial infarction within 6 months prior to starting trial treatment. 6. are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended. 7. childbearing potential who are: a) are nursing or b) are pregnant or c) are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol 8. any history of or concomitant condition that, in the opinion of the treating physician, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug 9. previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured. 10. requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 of the protocol that can not be stopped for the duration of trial participation 11. known pre-existing interstitial lung disease 12. presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug based on treating physician assessment. 13. active hepatitis B infection, active Hepatitis C (HEP C) infection and/or known Human Immunodeficiency Virus (HIV) carrier. 14. meningeal carcinomatosis 15. symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication) |
N/A
Country | Name | City | State |
---|---|---|---|
United States | 1200.45.105 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico |
United States | 1200.45.095 Boehringer Ingelheim Investigational Site | Alpharetta | Georgia |
United States | 1200.45.078 Boehringer Ingelheim Investigational Site | Anaheim | California |
United States | 1200.45.053 Boehringer Ingelheim Investigational Site | Ann Arbor | Michigan |
United States | 1200.45.029 Boehringer Ingelheim Investigational Site | Athens | Georgia |
United States | 1200.45.071 Boehringer Ingelheim Investigational Site | Billings | Montana |
United States | 1200.45.086 Boehringer Ingelheim Investigational Site | Bismarck | North Dakota |
United States | 1200.45.080 Boehringer Ingelheim Investigational Site | Brooklyn | New York |
United States | 1200.45.114 Boehringer Ingelheim Investigational Site | Burbank | California |
United States | 1200.45.090 Boehringer Ingelheim Investigational Site | Canton | Ohio |
United States | 1200.45.093 Boehringer Ingelheim Investigational Site | Charleston | West Virginia |
United States | 1200.45.001 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
United States | 1200.45.019 Boehringer Ingelheim Investigational Site | Columbia | Maryland |
United States | 1200.45.005 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
United States | 1200.45.049 Boehringer Ingelheim Investigational Site | Cookeville | Tennessee |
United States | 1200.45.024 Boehringer Ingelheim Investigational Site | Decatur | Illinois |
United States | 1200.45.046 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
United States | 1200.45.113 Boehringer Ingelheim Investigational Site | El Paso | Texas |
United States | 1200.45.009 Boehringer Ingelheim Investigational Site | Evanston | Illinois |
United States | 1200.45.045 Boehringer Ingelheim Investigational Site | Fairfax | Virginia |
United States | 1200.45.066 Boehringer Ingelheim Investigational Site | Freehold | New Jersey |
United States | 1200.45.068 Boehringer Ingelheim Investigational Site | Fresh Meadows | New York |
United States | 1200.45.123 Boehringer Ingelheim Investigational Site | Glendale | California |
United States | 1200.45.116 Boehringer Ingelheim Investigational Site | Goodyear | Arizona |
United States | 1200.45.020 Boehringer Ingelheim Investigational Site | Hershey | Pennsylvania |
United States | 1200.45.026 Boehringer Ingelheim Investigational Site | Hollywood | Florida |
United States | 1200.45.097 Boehringer Ingelheim Investigational Site | Hollywood | Florida |
United States | 1200.45.057 Boehringer Ingelheim Investigational Site | Hot Springs | Arkansas |
United States | 1200.45.100 Boehringer Ingelheim Investigational Site | Jackson | Mississippi |
United States | 1200.45.017 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
United States | 1200.45.058 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
United States | 1200.45.096 Boehringer Ingelheim Investigational Site | Johnstown | Pennsylvania |
United States | 1200.45.016 Boehringer Ingelheim Investigational Site | Lakeland | Florida |
United States | 1200.45.115 Boehringer Ingelheim Investigational Site | Lakewood | California |
United States | 1200.45.117 Boehringer Ingelheim Investigational Site | Long Beach | California |
United States | 1200.45.042 Boehringer Ingelheim Investigational Site | Macon | Georgia |
United States | 1200.45.083 Boehringer Ingelheim Investigational Site | Marrero | Louisiana |
United States | 1200.45.087 Boehringer Ingelheim Investigational Site | Metairie | Louisiana |
United States | 1200.45.103 Boehringer Ingelheim Investigational Site | Miami Beach | Florida |
United States | 1200.45.048 Boehringer Ingelheim Investigational Site | Minot | North Dakota |
United States | 1200.45.004 Boehringer Ingelheim Investigational Site | Mobile | Alabama |
United States | 1200.45.102 Boehringer Ingelheim Investigational Site | Monterey | California |
United States | 1200.45.051 Boehringer Ingelheim Investigational Site | New York | New York |
United States | 1200.45.092 Boehringer Ingelheim Investigational Site | New York | New York |
United States | 1200.45.021 Boehringer Ingelheim Investigational Site | Omaha | Nebraska |
United States | 1200.45.037 Boehringer Ingelheim Investigational Site | Orlando | Florida |
United States | 1200.45.099 Boehringer Ingelheim Investigational Site | Peoria | Illinois |
United States | 1200.45.060 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
United States | 1200.45.091 Boehringer Ingelheim Investigational Site | Pleasant Hill | California |
United States | 1200.45.098 Boehringer Ingelheim Investigational Site | Pleasant Hill | California |
United States | 1200.45.056 Boehringer Ingelheim Investigational Site | Port St. Lucie | Florida |
United States | 1200.45.094 Boehringer Ingelheim Investigational Site | Portland | Oregon |
United States | 1200.45.085 Boehringer Ingelheim Investigational Site | Pottstown | Pennsylvania |
United States | 1200.45.006 Boehringer Ingelheim Investigational Site | Ranco Cucamonga | California |
United States | 1200.45.120 Boehringer Ingelheim Investigational Site | Rapid City | South Dakota |
United States | 1200.45.039 Boehringer Ingelheim Investigational Site | Rockville | Maryland |
United States | 1200.45.076 Boehringer Ingelheim Investigational Site | Seattle | Washington |
United States | 1200.45.003 Boehringer Ingelheim Investigational Site | Southington | Connecticut |
United States | 1200.45.067 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
United States | 1200.45.007 Boehringer Ingelheim Investigational Site | Stamford | Connecticut |
United States | 1200.45.119 Boehringer Ingelheim Investigational Site | Titusville | Florida |
United States | 1200.45.089 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma |
United States | 1200.45.121 Boehringer Ingelheim Investigational Site | Valdosta | Georgia |
United States | 1200.45.040 Boehringer Ingelheim Investigational Site | Waterloo | Iowa |
United States | 1200.45.125 Boehringer Ingelheim Investigational Site | Wausau | Wisconsin |
United States | 1200.45.041 Boehringer Ingelheim Investigational Site | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |