Phase 4 N=62 Treatment

A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

Non-Squamous Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01609543 ↗

Enrolled (actual)

Serious AEs

41.9%

Results posted

Feb 2016

Primary outcome: Primary: Progression-Free Survival (PFS) — 12.846 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: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS)	12.846	—
SECONDARY Percentage of Participants With Best Overall Response (BOR)	1.8; 64.3; 32.1; 1.8	—
SECONDARY Percentage of Participants Who Were Alive at 1 Year	82.5	—

Summary

This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Eligibility Criteria

Inclusion Criteria

Adult patients, >/= 18 years of age
Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
Non-small cell lung cancer with an EGFR activating mutation
Patients must have evidence of disease, but measurable disease is not mandatory
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate renal and liver function

Exclusion Criteria

Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
Pregnant or breast-feeding women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01609543). 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.