A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01996332

ML17915

Details and patient eligibility

About

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

Enrollment: 1,805 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• locally advanced or metastatic NSCLC (Stage IIIB or IV);
• not a candidate for curative surgery or radical chemotherapy;
• no brain metastases, or clinically stable metastases for >=2 months.

Exclusion criteria

• radiotherapy over the previous 2 weeks;
• weight loss >10% in the previous 6 weeks.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,805 participants in 1 patient group

Tarceva Arm

Experimental group

Treatment:

Drug: erlotinib [Tarceva]