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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Time Frame:

from the first cycle of treatment (day one) to two month after the last cycle

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

ABX-CJH

NCT ID:

NCT01810367

Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • PFS
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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