Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer

Study Overview
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Brief Summary
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Determine tumor response rate and time to disease progression, survival and safety in total populations.

Detailed Description
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To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.

Official Title
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A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Non-Small-Cell Lung Cancer

Intervention / Treatment
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* Biological: Cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination Unidimensionally measurable NSCLC Subjects with tumor tissue available for EGFR assessment ECOG performance status of 0 or 1 Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids Exclusion Criteria Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception Women of childbearing potential using a prohibited contraceptive method Women who were pregnant or breastfeeding Women with a positive pregnancy test on enrollment or prior to study drug administration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes). | Biological: Cetuximab<br>* Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects. |  | Every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the tumor response rate in the total population and in EGFR- subjects |  | Every 8 weeks | 
| Time to disease progression in the EGFR+ and total populations. |  | Every 8 weeks | 
| Survival in the EGFR+ and total populations. |  | Every 8 weeks | 
| Safety in the EGFR+ and total populations. |  | Every 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non, Small, Cell, Lung, Cancer