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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01328951

Run by

Hoffmann-La Roche

People needed

643

Starts

2011-09-01

Expected to finish

2016-01-01

Last updated by the study team

2016-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Washington D.C., District of Columbia, United States
• Study site — Kansas City, Missouri, United States
• Study site — Missoula, Montana, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Dayton, Ohio, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Spokane, Washington, United States
• Study site — Tacoma, Washington, United States
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Lajeado, Rio Grande do Sul, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — Porto Alegre, Rio Grande do Sul, Brazil
• Study site — Ijuí, Rondônia, Brazil
• Study site — Florianópolis, Santa Catarina, Brazil
• Study site — Santo André, São Paulo, Brazil
• Study site — Gabrovo, Bulgaria
• Study site — Haskovo, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Gilroy, California, United States

Full record on ClinicalTrials.gov

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