Clinical trial · Interventional
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study
NCT01109524CI-TRIAL-00020332completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab + Cisplatin + Vinorelbine
- interventionNames
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Vinorelbine
Primary outcomes (7)
- measure
- 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
- timeFrame
- Day 1 up to 30 days after last dose
- description
- AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \< 3,000/mm³ * Absolute neutrophile count (ANC) \< 1,500/mm³ * Platelet \< 100,000/mm³ * Hemoglobin (Hgb) \< 9.0 g/dL * Total bilirubin \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.