Clinical trial · Interventional
MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer
Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.
NCT01405586CI-TRIAL-00064972MILES-3unknownPhase 3ClinicalTrials.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 to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.
Conditions
Conditions (2)
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 Metastatic | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- gemcitabine
- interventionNames
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- gemcitabine + cisplatin
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- one year
Secondary outcomes (4)
- measure
- worst grade toxicity per patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological or histological diagnosis of non small-cell lung cancer (NSCLC) * Stage III B or Stage IV disease * Age \> or = 70 years * ECOG Performance status 0 or 1 * Patient at first diagnosis or with recurrence after primary surgery * At least one target or non-target lesion according to RECIST criteria * Life expectancy of at least 3 months * Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl * Creatinine \< 1.5 x the upper normal limit * AST and ALT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis) * Bilirubin \< 1.5 x the upper normal limit * Signed informed consent Exclusion Criteria: * Previous chemotherapy for advanced disease * History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * Symptomatic cerebral or spinal cord metastasis * Myocardial infarct within the last 12 months * Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy. * Known or suspected hypersensitivity to any of the drugs used in the study * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.