Phase 4 N=24 Treatment

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01287754 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jun 2015

Primary outcome: Primary: Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation — 13.7 months

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: erlotinib [Tarceva] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation	13.7	—
SECONDARY Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1	2; 1	—
SECONDARY Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants	17.8; 11.3	—
SECONDARY Percentage of Participants Alive at 6 and 12 Months	100; 67; 100; 24	—
SECONDARY Percentage of Participants With EGFR Mutation at Screening	17	—

Summary

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Eligibility Criteria

Inclusion Criteria

Adult patients, >/=18 years of age
Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
Measurable disease according to RECIST criteria
ECOG performance status 0-2
Adequate haematological, renal and liver function

Exclusion Criteria

Previous chemotherapy or therapy against EGFR for metastatic disease
History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
Symptomatic cerebral metastases
Pre-existing parenchymal lung disease such as pulmonary fibrosis
Concomitant use of coumarins

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01287754). 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.