Non-Small-Cell Lung Cancer
Conditions
Keywords
Non, Small, Cell, Lung, Cancer
Brief summary
Determine tumor response rate and time to disease progression, survival and safety in total populations.
Detailed description
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
Interventions
BIOLOGICALCetuximab
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
Sponsors
Bristol-Myers Squibb
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC 2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination 3. Unidimensionally measurable NSCLC 4. Subjects with tumor tissue available for EGFR assessment 5. ECOG performance status of 0 or 1 6. Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids
Exclusion criteria
1. Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception 2. Women of childbearing potential using a prohibited contraceptive method 3. Women who were pregnant or breastfeeding 4. Women with a positive pregnancy test on enrollment or prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects. | Every 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Determine the tumor response rate in the total population and in EGFR- subjects | Every 8 weeks |
| Time to disease progression in the EGFR+ and total populations. | Every 8 weeks |
| Survival in the EGFR+ and total populations. | Every 8 weeks |
| Safety in the EGFR+ and total populations. | Every 8 weeks |
Countries
United States
Outcome results
None listed