Phase 3
Completed N=645
Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00112294 ↗Enrolled (actual)
645
Serious AEs
47.1%
Results posted
Oct 2010
Primary outcomePrimary: Median Number of Months of Progression-free Survival (PFS) — 4.40; 4.24 Months — p=0.2358
Summary
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Number of Months of Progression-free Survival (PFS) |
4.40; 4.24 | 0.2358 |
| SECONDARY Number of Participants With Complete Response (CR) or Partial Response (PR) |
87; 58 | 0.0066 sig |
| SECONDARY Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
230; 212 | 0.1501 |
| SECONDARY Median Number of Months of Response |
5.55; 4.90 | — |
| SECONDARY Median Number of Months to Response |
1.38; 1.35 | — |
| SECONDARY Median Number of Months of Survival |
9.69; 8.38 | 0.1685 |
| SECONDARY Number of Participants With Improvement of Symptoms |
107; 92 | 0.26 |
| SECONDARY Median Number of Months Until Symptomatic Progression (Worsening of Symptoms) |
— | — |
| SECONDARY Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs) |
38; 27; 183; 121; 324; 320 | — |
| SECONDARY Number of Participants Experiencing AEs Leading to Study Drug Discontinuation |
100; 0; 80; 54; 78; 52 | — |
| SECONDARY Number of Participants Experiencing Other Significant AEs: Acneform Rash |
246; 56 | — |
| SECONDARY Number of Participants Experiencing Other Significant AEs: Infusion Reaction |
45; 18 | — |
| SECONDARY Number of Participants Experiencing Other Significant AEs: Cardiac AEs |
58; 25 | — |
| SECONDARY Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants |
198; 177; 139; 97; 33; 29 | — |
| SECONDARY Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants |
33; 36; 26; 2; 25; 21 | — |
| SECONDARY Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures |
— | — |
Eligibility Criteria
Inclusion Criteria
- Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- Tumor/disease lesions that can be measured bidimensionally.
- Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
- Adequate recovery from recent surgery or radiation therapy.
- Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
- Accessible for treatment, follow-up and required visits at a participating center(s).
Exclusion Criteria
- Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
- Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
- Prior severe infusion reaction to antibody therapy.
- Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
- Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
- Serious uncontrolled medical disorders that would impair the ability to receive therapy.
- History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
- Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
- Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE] Version 3.0).
- Inadequate hematologic and/or liver and/or kidney function.
- Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment prior to study drug administration.
- Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
Data sourced from ClinicalTrials.gov (NCT00112294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.