Phase 4 Completed N=45 Randomized Treatment

Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

Source: ClinicalTrials.gov NCT02000531 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Jan 2016

Primary outcomePrimary: Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events — 26.3; 23.4 Months — p=>0.05

Summary

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR. This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events	26.3; 23.4	>0.05
SECONDARY Participants With Adverse Events	14; 12; 0; 1; 5; 2	—

Eligibility Criteria

Inclusion Criteria

Participant in ENSURE trial
Disease progression during first-line treatment

Exclusion Criteria

N/A

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02000531). 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.