A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Second-Line Chemotherapy; Drug: Placebo; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328951

BO25460

Details and patient eligibility

About

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.

Enrollment: 643 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
• Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
• Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

• Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
• Participants whose tumors harbor an EGFR-activating mutation
• Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
• Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
• Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
• Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
• Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
• Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
• Any inflammatory changes of the surface of the eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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643 participants in 2 patient groups, including a placebo group

Early Erlotinib

Experimental group

Description:

Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.

Treatment:

Drug: Second-Line Chemotherapy

Drug: Erlotinib

Late Erlotinib

Placebo Comparator group

Description:

Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.

Treatment:

Drug: Placebo

Drug: Erlotinib