Clinical trial · Interventional
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC
NCT00165334CI-TRIAL-00002483completedPhase 2ClinicalTrials.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 this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Vinorelbine (Navelbine) | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the overall response of cetuximab plus vinorelbine in patients 70 years or older with non-small lung cancer.
Secondary outcomes (2)
- measure
- To determine the safety of cetuximab plus vinorelbine in patients 70 years or older
- measure
- to determine the time to progression and survival rates of patients treated with cetuximab plus vinorelbine.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 70 years of age or greater * Stage IV or IIIB Non-small cell lung cancer * Must at least be able to walk and capable of taking care of yourself although unable to carry out work activities * 3 or more weeks since completing prior radiotherapy * 3 or more weeks since prior major surgery * Blood tests that show your kidneys, liver and bone marrow to be working adequately * Life expectancy of 8 weeks or more Exclusion Criteria: * Prior anticancer therapy within the past 3 years, including chemotherapy * Other currently active cancer * Uncontrolled Central Nervous System (CNS) problems * Pre-existing disease or abnormality of the nervous system * Hepatitis or Known HIV * Active uncontrolled infection * Incomplete healing from previous major surgery * Significant history of uncontrolled cardiac disease such as high blood pressure, recent heart attack (within past 6 months), congestive heart failure, etc. * Prior therapy which targets the ErbB pathway * Prior severe infusion reaction to an antibody * Chemotherapy or other investigational agent not indicated in the study protocol occuring at the same time as this study treatment * A medical condition that could make it unsafe for you to participate in this study
References
Publications (2)
- BACKGROUNDGridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V; MILES Investigators. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003 Mar 5;95(5):362-72. doi: 10.1093/jnci/95.5.362. PMID 12618501
- BACKGROUNDEffects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst. 1999 Jan 6;91(1):66-72. doi: 10.1093/jnci/91.1.66. PMID 9890172