A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: extensive stage Lung cancer; 10029107

• Registration Number: NL-OMON33131
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Key Inclusion Criteria:
- Histologically or cytologically confirmed SCLC
- Extensive disease, defined by at least one of the following criteria:
- No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
- Extrathoracic metastases
- Malignant pericardial or pleural effusion
- Contralateral hilar adenopathy
- Measurable or non-measurable disease, as defined by modified RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- >= 18 years old
- Life expectancy (with therapy) >= 3 months
- Adequate hematologic, hepatic, coagulation, renal, and metabolic function
- Diabetes, if present, must be controlled, with glycosylated hemoglobin (HgbA1c) <= 8% and fasting blood glucose level <= 160 mg/dL

Exclusion Criteria

Key Exclusion Criteria
- Prior chemotherapy, chemo-radiation, or investigational agent for SCLC
- Prior radiotherapy to > 25% of the bone marrow
- Symptomatic or untreated central nervous system (CNS) metastasis (with exceptions)
- Currently or previously treated with biological, immunological or other therapies for SCLC
- Current serious or non-healing wound or ulcer
- History of prior or concurrent other malignancy (with exceptions)
- Any clinically significant medical condition other than cancer (eg, cardiovascular disease or chronic obstructive pulmonary disease), which could interfere with the safe delivery of study treatment or increase risk of toxicity
- pregnancy or breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br>Part 1: * The incidence of adverse events and clinical laboratory abnormalities<br /><br>defined as DLT<br /><br>Part 2: * OS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>Part 1:<br /><br>- The incidence of adverse events and laboratory abnormalities not defined as<br /><br>DLT<br /><br>- The incidence of anti-AMG 479 and anti-AMG 102 antibody formation<br /><br>- PK (Cmax and Cmin for AMG 479 and AMG 102)<br /><br>Part 2:<br /><br>- ORR, DOR, TTP, PFS, mOS, and OS rates at 10,12, 24, and 36 months<br /><br>- The incidence of adverse events and laboratory abnormalities<br /><br>- The incidence of anti-AMG 479 and anti-AMG 102 antibody formation<br /><br>- PK (Cmax and Cmin) for AMG 479 and AMG 102<br /><br>- EORTC QLQ-C30 and EORTC QLQ-LC13 scores</p><br>