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NEXT: Cetuximab Maintenance in Advanced NSCLC

NCT00820755Phase 3

Key facts

Status: Completed
Start: Jan 2009
Primary completion: Dec 2011
Countries: 1
Sponsor: Merck KGaA
Modality: Monoclonal Antibodies

Drugs: KL-140
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, open-label trial of KL-140 in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Merck KGaA. Primary endpoints: Overall Survival and Percentage of Participants With 1-year Overall Survival. Started Jan 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Cetuximab 500 mg/m^2 q2w
Maintenance therapy with Cetuximab 500 mg/m^2 every 2 weeks.
Cetuximab 250 mg/m^2 q1w
Maintenance therapy with Cetuximab 250 mg/m^2 weekly.

Who it enrols

Adult patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC, ECOG 0-1, adequate organ function, and no prior EGFR therapy or chemotherapy for NSCLC (except adjuvant >6 months prior).

Endpoints

Primary

Overall SurvivalFrom inclusion to death
Percentage of Participants With 1-year Overall Survival1 year

Secondary

Overall Survival from RandomizationFrom randomization to death
Time to Treatment FailureFrom inclusion to failure
Time to Treatment Failure from RandomizationFrom randomization to failure
Best Unconfirmed Tumor Response
Disease Control Rate

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