N/A N=70

An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Non-Squamous Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01836133 ↗

Enrolled (actual)

Serious AEs

27.1%

Results posted

May 2017

Primary outcome: Primary: Progression-Free Survival (PFS) — 2.7 months

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Erlotinib 150 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS)	2.7	—
SECONDARY Percentage of Participants With Overall Response	8.57	—
SECONDARY Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)	0.56; 0.27; 0	—

Summary

This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.

Eligibility Criteria

Inclusion Criteria

Adult participants, >/= 18 years of age
Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate hematologic, renal and liver function
Participant initiating treatment with Tarceva according to the Summary of Product Characteristics

Exclusion Criteria

Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01836133). 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.