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The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS/β-Tubulin Expression

Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Carboplatin Adverse Reaction

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Trial Information

The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS/β-Tubulin Expression

Patients who had nonsmall cell lung cancer (NSCLC) performance status of 0/1 were accrued to
2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on
sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy
non-individuation ).

Patients who were treated on Trials B were analyzed as the "standard therapy" group.
Patients accrued to Trial A were called the "personalized therapy" group. Overall survival
(OS), disease free survival (DFS) and progression-free survival (PFS) were estimated using
the Kaplan-Meier method.

Inclusion Criteria:

1. Histological or cytological diagnosis of lung adenocarcinoma histology,

2. age from 18 years to 75 years

3. ECOG Performance Status no more than 2

4. at least one appraisable lung focus of diameter≥ 10 mm by lung CT

5. Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100
x 109/L

6. Total bilirubin ≤1.5 x upper limit of normal (ULN)

7. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of
liver metastases

8. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

1. Mixed non-adenocarcinoma cell lung cancer histology

2. Previous treatment for Systemic chemotherapy or local radiotherapy

3. Be allergic to chemotherapy drugs

Type of Study:


Study Design:

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

Outcome Measure:

progression-free survival of Patients

Outcome Description:

From treatment beginning,Patients will be followed for up to 2 years.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Jianxing He, Proressor

Investigator Role:

Study Chair

Investigator Affiliation:

The first affiliated hospital of Guangzhou MC


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

December 2013

Related Keywords:

  • Lung Cancer
  • Carboplatin Adverse Reaction
  • lung cancer
  • gemcitabine
  • carboplatin
  • pemetrexed
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms