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
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | January 2016 |
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of 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.
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.
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, gafitinib, 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
We found this trial at
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