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A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

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Roche

Status and phase

Completed
Phase 4

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Treatments

Drug: erlotinib [Tarceva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01066884
ML20569

Details and patient eligibility

About

This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients >= 18 years of age;
  • inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
  • ECOG performance status of 0-3;
  • previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion criteria

  • prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
  • unstable systemic disease;
  • any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • any significant ophthalmologic abnormality.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

1
Experimental group
Treatment:
Drug: erlotinib [Tarceva]

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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