Squamous cell carcinoma of the lung requiring second-line therapy
Conditions
Interventions
Trade Name: GIOTRIF
Product Name: afatinib
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: afatinib
Current Sponsor code: BIBW 2992
Concentration unit: mg milligra
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of advanced stage NSCLC considered to be squamous histology, including mixed histology. 2. Completion of at least 4 cycles of platinum-based doublet chemotherapy, with or without additional [non-EGFR] targeted agents, as 1st line treatment of Stage IIIB/IV NSCLC. Note the below scenarios are also considered to meet this requirement: a. Patients relapsing within 6 months of completing adjuvant/neo-advjuvant/curative -intent chemotherapy/chemoradiotherapy (Note: these patients are still required to have had the equivalent of 4 cycles of platinum-based doublet chemotherapy except in setting noted below). OR b. Patients intending to receive four cycles of platinum-based doublet chemotherapy but due to toxicity, and not PD, discontinue just the platinum agent after at least two cycles of platinum doublet had been administered 3. Eligible to receive 2nd line therapy in the opinion of the investigator. Patients who received non-EGFR based therapy for maintenance are eligible. 4. Measurable disease according to RECIST 1.1 (R09-0262). 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (R01-0787). 6. Availability of tumour tissue material for correlative studies. Archived tumour tissue is acceptable. 7. Adequate organ function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Prior treatment with EGFR directed small molecules or antibodies. 2. Curative intent chemoradiotherapy as the only treatment for stage IIIB NSCLC unless relapse occurs within 6 months of completion of treatment, and in the opinion of the investigator the patient has received an equivalent of 4 cycles of platinum-based doublet therapy. 3. Radiotherapy within 4 weeks prior to randomization. 4. Active brain metastases (stable for <4 weeks, symptomatic, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least 4 weeks before randomization. 5. Patients without Progressive Disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare efficacy of afatinib with erlotinib as second-line treatment for patients with squamous cell carcinoma of the lung, as measured by progression-free survival (PFS). ;Secondary Objective: Compare overall survival (OS) in both treatment groups. Objective response rate (ORR), disease control rate (DCR), tumour shrinkage and the assessment of Health-related Quality of Life (HRQoL) and safety in both treatment groups ;Primary end point(s): The primary endpoint of this study is progression-free survival, as determined by RECIST 1.1;Timepoint(s) of evaluation of this end point: 8, 12, and 16 weeks after randomization; and then every 18 weeks unless clinically indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival • Objective response (CR, PR) according to RECIST 1.1 • Disease control (CR, PR, SD) according to RECIST 1.1 • Tumour shrinkage • Health-related Quality of Life (HRQoL) ;Timepoint(s) of evaluation of this end point: Every 4 weeks | — |
Countries
Argentina, Austria, Belgium, Canada, Chile, China, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, Peru, Portugal, Singapore, Spain, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed