Clinical trial · Interventional
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
NCT00004883CI-TRIAL-00008951completedPhase 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)
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (trastuzumab)
- description
- Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: trastuzumab
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate (complete response [CR] and partial response [PR])
- timeFrame
- Up to 5 years
Secondary outcomes (5)
- measure
- Overall survival (OS)
- timeFrame
- From registration until death or last known follow-up, assessed up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed stage IIIB or IV non-small cell lung cancer
* Supraclavicular node involvement allowed
* Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
* No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
* Recurrent disease allowed
* HER2 overexpression (2-3+)
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques
* At least 10 mm by spiral CT scan
* The following are not considered measurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses not confirmed and followed by imaging
* Cystic lesions
* No CNS metastases
* Performance status - ECOG 0-2
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* LVEF at least 45% (by echocardiogram or MUGA)
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No concurrent immunologic disease (e.g., autoimmune disease)
* No history of allergy to murine products
* No prior murine antibodies
* No prior anthracyclines
* No more than 1 prior chemotherapy regimen for lung cancer
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
* No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
* No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
* At least 6 months since prior radiotherapy
* No concurrent palliative radiotherapy
* At least 4 weeks since prior major surgeryReferences
Publications (0)
Data not yet available
No reference posted for this study.