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A Phase II Trial of Pemetrexed Versus Erlotinib as Second-Line Therapy in Treating Patients With EGFR Wild-type Advanced Lung Adenocarcinoma


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

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Trial Information

A Phase II Trial of Pemetrexed Versus Erlotinib as Second-Line Therapy in Treating Patients With EGFR Wild-type Advanced Lung Adenocarcinoma


This trial will compare the efficacy of pemetrexed versus erlotinib in patients with EGFR
wild-type advanced lung adenocarcinoma.


Inclusion Criteria:



- Histologically or cytologically confirmed Lung adenocarcinoma

- Wld-type EGFR

- Stage IIIB/IV

- Failure to prior chemotherapy

- Life expectancy of more than 3 months

- Tissue sample desired for genomic study

- Age ≥ 18 years

- Performance status (WHO) < 3

- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9gr/mm^3)

- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2mg/dl)

- Presence of two-dimensional measurable disease. The measurable disease should not
have been irradiated

- Informed consent

Exclusion Criteria:

- Have previously received pemetrexed or TKIs

- Other concurrent uncontrolled illness

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Siyu Wang, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

wsy001

NCT ID:

NCT01565538

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Lung Cancer
  • Cancer
  • Non-small-cell lung cancer
  • Adenocarcinoma
  • EGFR gene mutation
  • Chemotherapy
  • Pemetrexed
  • Erlotinib
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms

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