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A Phase IIIb, Non-randomized, Open-label, Two-cohort Study in Patients With EGFR Mutations-positive Advanced Adenocarcinoma of the Lung, Assessing the Utility of the Afatinib Diarrhea Assessment and Management Guidelines (ADAM)


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

Thank you

Trial Information

A Phase IIIb, Non-randomized, Open-label, Two-cohort Study in Patients With EGFR Mutations-positive Advanced Adenocarcinoma of the Lung, Assessing the Utility of the Afatinib Diarrhea Assessment and Management Guidelines (ADAM)

Inclusion Criteria


Inclusion criteria:

1. Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the
lung, with EGFR mutations-positive status, who are not eligible to receive surgery or
chemoradiotherapy. Patients with mixed histology are eligible if adenocarcinoma is
the predominant histology, and is a suitable candidate for EGFR-TKI monotherapy, in
the opinion of the investigator.

2. Patients must have Epidermal Growth Factor Receptor (EGFR) mutation-positive status
according to the institutional standard of care.

3. Patient received no more than one (1) prior chemotherapy for locally advanced or
metastatic adenocarcinoma of the lung.

4. Male or female patients Age 18 years and older.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

6. Adequate organ function, defined as all of the following:

- Left Ventricular Ejection Fraction (LVEF) of above 50% or within institution
normal values

- Absolute neutrophil count (ANC) above 1500 / mm3.

- Platelet count above 75,000 / mm3.

- Estimated creatinine clearance more than 45ml / min.

- Total Bilirubin less than 1.5 times upper limit of (institutional/central)
normal

- Aspartate amino transferase (AST) or alanine amino transferase (ALT) less than
three times the upper limit of (institutional/central) normal (ULN) (if related
to liver metastases less than five times ULN).

7. Recovered from any previous therapy related toxicity to Grade 0 or 1 at study entry

8. Able and willing to follow diarrhea management guidelines provided under this study
and to complete Diarrhea Management Worksheet as instructed.

Exclusion criteria:

1. Chemotherapy, biological therapy or investigational agents within four weeks prior to
the start of study treatment.

2. Prior treatment with EGFR directed small molecules or antibodies.

3. Hormonal treatment within 2 weeks prior to start of study treatment (continued use of
anti-androgens and/or gonadorelin analogues for treatment of prostate cancer
permitted).

4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery
during the projected course of the study.

5. Known hypersensitivity to afatinib or the excipients of any of the trial drugs.

6. History or presence of clinically relevant cardiovascular abnormalities.

7. Any history of or concomitant condition that, in the opinion of the Investigator,
would compromise the patient¿s ability to comply with the study or interfere with the
evaluation of the efficacy and safety of the test drug.

8. Previous or concomitant invasive malignancies at other sites.

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

10. Any history or presence of poorly controlled gastrointestinal disorders that could
affect the absorption of the study drug.

14. Active hepatitis B infection, active hepatitis C infection and/or known HIV carrier,
who are determined by the investigator as not a suitable candidate to receive EGFR-TKI
treatment.

15. Patients with meningeal carcinomatosis. 16. Patients with brain or subdural
metastases.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurence of CTCAE Grade >= 2 diarrhea

Outcome Time Frame:

Up to 12 weeks

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

1200.167

NCT ID:

NCT01814553

Start Date:

April 2013

Completion Date:

February 2015

Related Keywords:

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

Name

Location

1200.167.01011 Boehringer Ingelheim Investigational Site Montebello, California  
1200.167.01009 Boehringer Ingelheim Investigational Site Santa Rosa, California  
1200.167.01010 Boehringer Ingelheim Investigational Site Galesburg, Illinois  
1200.167.01007 Boehringer Ingelheim Investigational Site Skokie, Illinois  
1200.167.01008 Boehringer Ingelheim Investigational Site Skokie, Illinois  
1200.167.01001 Boehringer Ingelheim Investigational Site Morristown, New Jersey  
1200.167.01004 Boehringer Ingelheim Investigational Site Columbia, South Carolina  
1200.167.01002 Boehringer Ingelheim Investigational Site Chattanooga, Tennessee  
1200.167.01006 Boehringer Ingelheim Investigational Site Chattanooga, Tennessee  
1200.167.01005 Boehringer Ingelheim Investigational Site Nashville, Tennessee  
1200.167.01003 Boehringer Ingelheim Investigational Site Richmond, Virginia