QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Phase 1

Terminated

• Conditions: Lung Cancer; Small Cell Lung Cancer; Extensive-stage Small Cell Lung Cancer; Solid Tumors

• Registration Number: NCT00791154
• Lead Sponsor: NantCell, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Key Inclusion Criteria<br><br> - Histologically or cytologically confirmed SCLC<br><br> - Extensive disease, defined by at least one of the following:<br><br> - No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can<br> be safely encompassed within a tolerable radiation field)<br><br> - Extrathoracic metastases<br><br> - Malignant pericardial or pleural effusion<br><br> - Contralateral hilar adenopathy<br><br> - Measurable or nonmeasurable disease, as defined by modified RECIST<br><br> - Eastern Cooperative Oncology Group (ECOG) status 0 or 1<br><br> - =18 years old<br><br> - Life expectancy (with therapy) =3 months<br><br> - Adequate hematologic, hepatic, coagulation, renal, and metabolic function<br><br> - Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) = 8%<br> and fasting glucose levels =160 mg/dL<br><br>Key Exclusion Criteria<br><br> - Prior chemotherapy, chemoradiation, or investigational agent for SCLC<br><br> - Prior radiotherapy to >25% of the bone marrow<br><br> - Symptomatic or untreated central nervous system metastases (with exceptions)<br><br> - Currently or previously treated with biologic, immunologic or other therapies for<br> SCLC<br><br> - Current serious or nonhealing wound or ulcer<br><br> - History of prior concurrent other malignancy (with exceptions)<br><br> - Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE,<br> TIA or MI<br><br> - Any clinically significant medical condition other than cancer (eg, cardiovascular<br> disease or COPD), which could interfere with the safe delivery of study treatment or<br> risk of toxicity

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival in Ganitumab Treated Subjects -Phase 2;Overall Survival in Rilotumumab Treated Subjects-Phase 2;Number of Subjects With Dose Limiting Toxicities-Phase 1