Phase 3
Completed N=643
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
Source: ClinicalTrials.gov NCT01328951 ↗Enrolled (actual)
643
Serious AEs
8.9%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Who Died During the Overall Study — 73.2; 75.2 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Died During the Overall Study |
73.2; 75.2 | — |
| PRIMARY Overall Survival (OS) as Median Time to Event During the Overall Study |
9.46; 9.72 | 0.8183 |
| PRIMARY Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study |
41.75; 42.15 | 0.9207 |
| SECONDARY Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment |
95.0; 94.1 | — |
| SECONDARY Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment |
12.00; 13.00 | 0.4759 |
| SECONDARY Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment |
24.22; 27.11 | 0.4069 |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment |
3.7; 6.5 | 0.1097 |
| SECONDARY Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment |
0.6; 0.9; 3.1; 5.6; 55.5; 54.7 | — |
| SECONDARY Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment |
59.2; 61.2 | 0.6062 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01328951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.