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

NantCell

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Drug: Cisplatin; Drug: Etoposide; Drug: Carboplatin; Drug: AMG 479; Drug: AMG 102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791154

NCT00791154 (Other Identifier)

QUILT-2.013 (Other Identifier)

Details and patient eligibility

About

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Histologically or cytologically confirmed SCLC
• Extensive disease, defined by at least one of the following:
• 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 nonmeasurable disease, as defined by modified RECIST
• Eastern Cooperative Oncology Group (ECOG) 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 (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL

Key Exclusion Criteria

• Prior chemotherapy, chemoradiation, or investigational agent for SCLC
• Prior radiotherapy to >25% of the bone marrow
• Symptomatic or untreated central nervous system metastases (with exceptions)
• Currently or previously treated with biologic, immunologic or other therapies for SCLC
• Current serious or nonhealing wound or ulcer
• History of prior concurrent other malignancy (with exceptions)
• Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
• Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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213 participants in 3 patient groups, including a placebo group

ARM A

Experimental group

Description:

Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide

Treatment:

Drug: AMG 479

Drug: Carboplatin

Drug: Etoposide

Drug: Cisplatin

ARM B

Experimental group

Description:

Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Treatment:

Drug: AMG 102

Drug: Carboplatin

Drug: Etoposide

Drug: Cisplatin

ARM C

Placebo Comparator group

Description:

Blinded placebo and carboplatin or cisplatin and etoposide

Treatment:

Drug: Placebo

Drug: Carboplatin

Drug: Etoposide

Drug: Cisplatin