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

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)

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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]