Clinical trial · Interventional
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials
NCT01810367CI-TRIAL-00021049completedPhase 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)
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of 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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABX Combined With Cisplatin | Drug | — | UNRESOLVED |
| Gemcitabine Combined With Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABX Combined With Cisplatin
- description
- ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt
- interventionNames
- Drug: ABX Combined With Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine Combined With Cisplatin
- description
- gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.
- interventionNames
- Drug: Gemcitabine Combined With Cisplatin
Primary outcomes (1)
- measure
- PFS
- timeFrame
- from the first cycle of treatment (day one) to two month after the last cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
1.18\~75 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.