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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Biological: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00063388

CA225-012

Details and patient eligibility

About

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

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
3. Unidimensionally measurable NSCLC
4. Subjects with tumor tissue available for EGFR assessment
5. ECOG performance status of 0 or 1
6. 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

1. 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
2. Women of childbearing potential using a prohibited contraceptive method
3. Women who were pregnant or breastfeeding
4. Women with a positive pregnancy test on enrollment or prior to study drug administration.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 1 patient group

1

Experimental group

Description:

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).

Treatment:

Biological: Cetuximab