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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01810367

Enrollment

Registered

2013-03-13

Start date

2011-12-31

Completion date

2015-12-31

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

PFS

Brief summary

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

Interventions

DRUGABX Combined With Cisplatin

DRUGGemcitabine Combined With Cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PFS	from the first cycle of treatment (day one) to two month after the last cycle

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026