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A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21


Phase 2
18 Years
75 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21


Inclusion Criteria:



- NSCLC confirmed by histopathology or cytology;

- Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung
Staging Standard version 7 2009, and be unresectable;

- Has active mutation of EGFR in exon 19 or 21;

- Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >=
10mm; if the evaluable lesion is lymph node, the shortest dimension should be
measured and >=15mm];

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;

- expectancy life >= 12 weeks;

Exclusion Criteria:

- Had be treated by HER-targeting agents;

- Had systemic anit-NSCLC treatments;

- Had local radiotherapy for NSCLC;

- Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or
intolerance of oral medication, or active peptic ulcer;

- Diagnosed other malignant tumor besides NSCLC within 5 years prior the study
treatment (except having simple surgical resection with 5-year disease free survival,
cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder
epithelial tumor);

- Any evidence to indicate moderate or severe chronic obstructive pulmonary disease
(COPD);

- Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI)
agents or relevant components in the formulation;

- Uncontrolled eye inflammation or infection, or any potential circumstances lead to
eye inflammation or infection;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progress Free Survival (PFS)

Outcome Description:

The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jinming Yu, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Shandong Cancer Hospital and Institute

Authority:

China: Food and Drug Administration

Study ID:

ML28545

NCT ID:

NCT01714908

Start Date:

October 2012

Completion Date:

December 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • EGFR mutation
  • unresectable
  • erlotinib
  • concurrent radiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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