ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

Fudan University

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: ABX Combined With Cisplatin

Drug: Gemcitabine Combined With Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01810367

ABX-CJH

Details and patient eligibility

About

Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

Enrollment

84 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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