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A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy


Inclusion Criteria:



- male patients, >/=18 years of age

- former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before
enrollment)

- locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small
cell lung cancer

- prior platinum-based therapy for advanced NSCLC

- ECOG performance status 0-1

Exclusion Criteria:

- uncontrolled symptomatic central nervous system (CNS) metastases

- prior therapy against epidermal growth factor receptor (EGFR)

- >1 prior chemotherapy for advanced/metatstatic NSCLC

- radiotherapy <28 days prior to enrollment

- history of melanoma at any time, or another malignancy in the last 5 years except for
carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or
surgically cured malignant neoplasias with a disease-free interval of >5 years

- not fully treated eye inflammation or infection, or predisposing conditions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of progression-free survival (tumour assessments according to RECIST criteria)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML21869

NCT ID:

NCT01204697

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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