Clinical trial · Interventional
Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small
NCT01192243CI-TRIAL-00003870unknownPhase 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 purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin or carboplatin | Drug | Cisplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- response rate
- timeFrame
- six weeks
Secondary outcomes (3)
- measure
- Number of Participants with Adverse Events
- timeFrame
- six weeks
- description
- according to NCI CTC V3.0
- measure
- Progression free survival
- timeFrame
- six weeks
- measure
- quality of life
- timeFrame
- six weeks
- description
- according to FACT-LCS scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer * Age from 18 to 70 years old * At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools * ECOG 0-1 * Expected life time longer than 12 weeks * Normal laboratory values: leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis) Exclusion Criteria: * Patients have not used drugs according to protocol * Patients were allergic to pemetrexed or cisplatin * Patients received radiotherapy or other biological treatment 4 weeks before the trial * Uncontrolled hydrothorax or hydropericardium * neuropathy toxicity ≥ CTC 3 * Severe symptomatic heart disease * Active upper gastrointestinal ulcer or digestive disfunction * Severe infection or metabolic disfunction * Patients with other malignant tumor * Uncontrolled brain metastases * Patients have accepted other clinical trials * Female patients during their pregnant and lactation period, or patients without contraception
References
Publications (0)
Data not yet available
No reference posted for this study.