Phase 2
Completed N=208
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
Source: ClinicalTrials.gov NCT01310036 ↗Enrolled (actual)
208
Serious AEs
28.5%
Results posted
Sep 2018
Primary outcomePrimary: Progression-free Survival Per RECIST, v. 1.1 (PFS1) — 11.000 months
Summary
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Per RECIST, v. 1.1 (PFS1) |
11.000 | — |
| SECONDARY Progression-free Survival Per Investigator (PFS2) |
15.000 | — |
| SECONDARY Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R |
72.3; 72.9 | — |
| SECONDARY Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R |
84.5; 85.4 | — |
| SECONDARY Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1) |
11.000 | — |
| SECONDARY Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R |
31.633; 31.800 | — |
| SECONDARY Number of Participants With Adverse Events |
206 | — |
| SECONDARY Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Stage IV or recurrent non-small cell lung cancer (NSCLC)
- Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
- Measurable disease (at least one lesion >= 10 mm in longest diameter)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematological, renal and liver function
Exclusion Criteria
- Patients with T790M single mutation only
- Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
- Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
- Symptomatic or uncontrolled central nervous system (CNS) metastases
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
- Any significant ophthalmologic abnormality
- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
Data sourced from ClinicalTrials.gov (NCT01310036). 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.