Clinical trial · Interventional
Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC
A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
NCT02175381CI-TRIAL-00017922completedPhase 1 / Phase 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 investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with 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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carbo/GEM
- interventionNames
- Drug: Carboplatin
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Disease evaluation at Week 8
Secondary outcomes (4)
- measure
- Disease control rate
- timeFrame
- Disease evaluation at Week 8
- description
- Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥70 years old * Cytologically or histologically documented NSCLC * Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion) * World Health Organisation (WHO) performance status 0-2 * Non-frail patients according to Comprehensive Geriatric Assessment * Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part) * No prior chemotherapy (for phase II part) * Life expectancy of at least 12 weeks * Serum bilirubin less than 1.5 times the upper normal limit * Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases * Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min * Neutrophil count more than 1.5x 109 /L * Platelet count more than 100x 109 /L * Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations. Exclusion Criteria: * Hemoptysis * Central nervous system metastases * Clinically significant cardiovascular disease * Medically uncontrolled hypertension * Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ) * Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
References
Publications (0)
Data not yet available
No reference posted for this study.