Clinical trial · Interventional
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
NCT01769066CI-TRIAL-00021042completedPhase 2 / Phase 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 aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
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 |
|---|---|---|---|
| Pemetrexed/Platinum | Drug | — | UNRESOLVED |
| Sequential Gefitinib With Pemetrexed/Platinum | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sequential Gefitinib With Pemetrexed/Platinum
- description
- Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16
- interventionNames
- Drug: Sequential Gefitinib With Pemetrexed/Platinum
- type
- ACTIVE_COMPARATOR
- label
- Pemetrexed/Platinum
- description
- Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1
- interventionNames
- Drug: Pemetrexed/Platinum
Primary outcomes (1)
- measure
- 12 weeks of non-progression rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18\~70 years 2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3. Presence of at least one index lesion measurable by CT scan or MRI 4. Ecog0-1 5. Expected life time longer than 12 weeks 6. 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) 7. Signed written informed consent Exclusion Criteria: * Patients have 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.