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
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 28, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Placebo; Drug: Erlotinib; Drug: Second-Line Chemotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationGilroy, California
- Study locationWashington D.C., District of Columbia
- Study locationKansas City, Missouri
- Study locationMissoula, Montana
- Study locationLebanon, New Hampshire
- Study locationDayton, Ohio
- Study locationChattanooga, Tennessee
- Study locationSpokane, Washington
- Study locationTacoma, Washington
- Study locationBelo Horizonte, Minas Gerais
- Study locationLajeado, Rio Grande do Sul
- Study locationPorto Alegre, Rio Grande do Sul
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2016. Always confirm current availability with the study team.