Locally advanced or metastatic non small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic
Conditions
Interventions
Trade Name: Sutent
Product Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib Malate
CAS Number: 341031-54-7
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Histologically or cytologically proven diagnosis of NSCLC with evidence of disease that is recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC) and for which erlotinib treatment is clinically indicated. Note: Diagnosis via sputum is not considered acceptable. 2. Prior treatment with 1 or 2 chemotherapy regimens (must have included a platinum-based regimen) for advanced disease (Stage IIIB with malignant effusion or Stage IV NSCLC). 3. Disease progression during or after first-line chemotherapy 4. Measurable or nonmeasurable disease. 5. Male or female, 18 years of age or older. 6. ECOG performance status 0 or 1. 7. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade =1 (except alopecia). 8. Adequate organ function as defined by the following criteria: • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST and ALT =5 x ULN if liver function abnormalities are due to underlying malignancy • Total serum bilirubin =1.5 x ULN • Serum albumin =3.0 g/dL • Absolute neutrophil count (ANC) =1500/µL • Platelets =100,000/µL • Hemoglobin =9.0 g/dL • Serum creatinine =1.5 x ULN 9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Prior treatment with any receptor tyrosine kinase inhibitors (including but not limited to sunitinib, erlotinib, and gefitinib), VEGF inhibitors (with the exception of bevacizumab), or other angiogenesis inhibitors (including but not limited to thalidomide). Note: Patients previously treated with cetuximab will not be considered eligible for study entry. 2. Treatment with sunitinib and/or erlotinib if it is contraindicated according to the local prescribing information. 3. Major surgery within 4 weeks of study treatment. At least 7 days should elapse since minor surgical procedure including placement of an access device or fine needle aspiration. 4. Tumor (any histology) that involves a major blood vessel (eg, no aortic involvement). 5. Major radiation therapy within 4 weeks of study treatment except palliative radiotherapy to non-target metastatic lesions. 6. Systemic anticancer therapy within 4 weeks of starting the study treatment. 7. Prior treatment with a platinum-based regimen as adjuvant therapy following resection for early-stage NSCLC. 8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 9. Prior radiation therapy to >25% of the bone marrow. 10. Evidence of hemoptysis 450 msec for males or >470 msec for females. 15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 16. Severe dry eye syndrome, Sjogren's syndrome, severe exposure keratopathy, bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis, or clinically significant gastrointestinal abnormalities including uncontrolled inflammatory disease (eg, Crohn's or ulcerative colitis). 17. Known human immunodeficiency virus infection. 18. Current treatment on another clinical trial. 19. Pregnancy or breastfeeding. Female, who is pregnant or nursing; fertile patient who is unwilling or unable to use adequate contraception to prevent pregnancy during the program (Section 4.3). All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: • To demonstrate that the combination of sunitinib plus erlotinib is superior to erlotinib plus placebo in prolonging the overall survival for advanced/metastatic NSCLC patients who have received 1 to 2 prior chemotherapy regimens. ; Secondary Objective: Secondary Objectives: • To compare measures of antitumor response [progression-free survival (PFS); overall response rate (ORR)] between both treatment arms and estimate duration of tumor control [duration of response (DR)]. • To compare the safety and tolerability of erlotinib plus sunitinib versus erlotinib plus placebo in this patient population • To assess patient-reported outcomes. ;Primary end point(s): Overall Survival (OS) | — |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Slovakia, Spain, United Kingdom
Outcome results
None listed