Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer
The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 25, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Alabama at Birmingham
- Interventions being studied
- Drug: Cetuximab in combination with Carboplatin/Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
- Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
- Have Stage IV or recurrent disease following radiation therapy.
- Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
- Have given signed informed consent.
- Be at least 18 years of age.
- Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
- Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
- Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
- Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
- Agree to use effective contraception if procreative potential exists.
- Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.
- Have received prior murine monoclonal antibody or Cetuximab therapy.
- Have disease amenable to curative surgery.
- Have received prior chemotherapy.
- Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
- Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
- Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
- Be pregnant or breast-feeding.
- Have received any investigational agent(s) within 1 month of study entry.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 25, 2023. Always confirm current availability with the study team.