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A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

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Roche

Status and phase

Completed
Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: erlotinib [Tarceva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT02013206
MO18660

Details and patient eligibility

About

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients, >=18 years of age;
  • histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • no previous chemotherapy.

Exclusion criteria

  • previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
  • clinical evidence of brain metastasis;
  • any unstable systemic disease;
  • unable to take oral medication;
  • any significant ophthalmological abnormality.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Never Smokers
Experimental group
Description:
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
Treatment:
Drug: erlotinib [Tarceva]
Current/Former Smokers
Experimental group
Description:
Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
Treatment:
Drug: erlotinib [Tarceva]

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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