Clinical trial · Interventional
Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
NCT00063388CI-TRIAL-00003356completedPhase 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)
Determine tumor response rate and time to disease progression, survival and safety in total populations.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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).
- interventionNames
- Biological: Cetuximab
Primary outcomes (1)
- measure
- The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
- timeFrame
- Every 8 weeks
Secondary outcomes (4)
- measure
- Determine the tumor response rate in the total population and in EGFR- subjects
- timeFrame
- Every 8 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.