Phase 2
Completed N=60
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
Lung Cancer · Carcinoma · Cancer of the Lung · Non-Small Cell Lung Carcinoma
Source: ClinicalTrials.gov NCT01109524 ↗
Enrolled (actual)
60
Serious AEs
63.3%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population — 3; 2; 38; 59 participants
Summary
The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population |
3; 2; 38; 59; 46; 21 | — |
| PRIMARY Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population |
5; 2; 3; 9; 0; 3 | — |
| PRIMARY Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population |
37; 0; 3; 0; 31; 0 | — |
| PRIMARY Number of Participants With Hematology Laboratory Abnormalities - Treated Population |
51; 4; 0; 19; 1; 0 | — |
| PRIMARY Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population |
42; 18; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population |
16; 54; 31; 11 | — |
| PRIMARY Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population |
5; 2; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
- Evaluable or measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
- Uncontrolled Central Nervous System (CNS) metastasis.
- Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
- Concurrent malignancy
- Prior chemotherapy for NSCLC
- Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
- Superior vena cava syndrome contra-indicating hydration
- White Blood Cells (WBC) 1.5 x Upper limit of normal (ULN).
- Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
- Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min
Data sourced from ClinicalTrials.gov (NCT01109524). 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.