Purpose

This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.

Category

IRB Number
20150454HU
NCT Number
NCT02438722
Open to Enrollment
Yes
Sponsor
Southwest Oncology Group -



Study Contact

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Principal Investigator
Anand Karnad

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Anand Karnad
(210) 450-1667
karnad@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2/Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Recurrent Non-Small Cell Lung Carcinoma
    2. Stage IV Non-Small Cell Lung Cancer

      3. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      Arm II (afatinib dimaleate)

      		Patients receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    3. Drug: Afatinib Dimaleate

      Given PO

      Other names:

      • (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)
      • BIBW 2992MA2
      • BIBW2992 MA2

    4. Other: Laboratory Biomarker Analysis

      Correlative studies

      5. Experimental

      Arm I (afatinib dimaleate, cetuximab)

      		Patients receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    5. Drug: Afatinib Dimaleate

      Given PO

      Other names:

      • (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)
      • BIBW 2992MA2
      • BIBW2992 MA2

    6. Other: Laboratory Biomarker Analysis

      Correlative studies

    7. Biological: Cetuximab

      Given IV

      Other names:

      • Chimeric Anti-EGFR Monoclonal Antibody
      • Chimeric MoAb C225
      • Chimeric Monoclonal Antibody C225
      • Erbitux
      • IMC-C225

      8.