Clinical trial · Interventional
Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
- 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)
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (\> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (\> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine. The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| gemcitabine and carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks
- interventionNames
- Drug: gemcitabine and carboplatin
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Gemcitabine 1000mg/m2 Day 1, 8, 15
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Efficacy (response rate)
- timeFrame
- two-years, followed RECIST criteria
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 76 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer * Good performance status (ECOG 0-1) * No previous treatment * Age 76 years and older * Adequate bone marrow, liver and renal functions * No pregnant * Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>=1.0 cm by spiral CT scan * Provided written informed consent Exclusion Criteria: * Severe complications or a concomitant malignancy * Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors * Interstitial pneumonia or lung fibrosis * Contraindicated gemcitabine or carboplatin * Inappropriate patients for entry to this study, judged by the physicians
References
Publications (1)
- DERIVEDKusagaya H, Inui N, Karayama M, Nakamura Y, Kuroishi S, Yokomura K, Toyoshima M, Shirai T, Masuda M, Yamada T, Yasuda K, Suda T, Chida K. Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer. 2012 Sep;77(3):550-5. doi: 10.1016/j.lungcan.2012.05.106. Epub 2012 Jun 15. PMID 22705118