Clinical trial · Interventional
Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
NCT00293280CI-TRIAL-00010219completedPhase 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)
RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lomustine | Drug | Lomustine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (5)
- measure
- Toxicity
- measure
- Disease stabilization
- measure
- Time to disease progression
- measure
- Overall survival
- measure
- Association between clinical outcome and immunohistochemical staining
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes: * Squamous cell * Adenocarcinoma * Adenosquamous * Large cell anaplastic * Bronchoalveolar * Non-small cell carcinoma not otherwise specified (NOS) * Stage IIIB disease (with a pleural effusion) or stage IV disease * Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy * Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction * Bidimensionally measurable or evaluable disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No other active malignancies * WBC ≥ 4,000/mm\^3 OR absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin normal * AST \< 5 times upper limit of normal * Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * No uncontrolled serious active infection * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 weeks since prior chemotherapy * No more than 2 prior chemotherapy regimens * No prior therapy with nitrosoureas * Recovered from prior radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.