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

NCT00791154 | Terminated Phase 1 Results

• 2 other identifiers: QUILT-2.013NCT00791154
• Study Type: interventional
• Target: 213
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Extensive disease; Extrathoracic metasasis; Malignant pericardial effusion; Malignant pleural effusion; Contralateral hilar adenopathy

Outcome Measures

Primary Outcomes (3)

• Overall Survival in Ganitumab Treated Subjects -Phase 2

  The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause

  Time from randomization to death from any cause, approximately 14 months

• Overall Survival in Rilotumumab Treated Subjects-Phase 2

  The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause

  Time from randomization to death from any cause, approximately 14 months

• Number of Subjects With Dose Limiting Toxicities-Phase 1

  For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.

  First 21 days after start of study treatment

Study Arms (3)

ARM A

EXPERIMENTAL

Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide

Drug: AMG 479; Drug: Etoposide; Drug: Carboplatin; Drug: Cisplatin

ARM B

EXPERIMENTAL

Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide

Drug: Etoposide; Drug: AMG 102; Drug: Carboplatin; Drug: Cisplatin

ARM C

PLACEBO COMPARATOR

Blinded placebo and carboplatin or cisplatin and etoposide

Drug: Etoposide; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin

Interventions

AMG 479 DRUG

AMG 479 is administered to subjects

ARM A

Etoposide DRUG

Etoposide is administered to subjects

ARM A; ARM B; ARM C

Placebo DRUG

Placebo is administered with Carboplatin and Etoposide

ARM C

AMG 102 DRUG

AMG 102 is administered to subjects

ARM B

Carboplatin DRUG

Carboplatin is administered to some subjects in combination

ARM A; ARM B; ARM C

Cisplatin DRUG

Cisplatin is administered to some subjects in combination

ARM A; ARM B; ARM C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NantCell, Inc.: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma; Pleural Effusion, Malignant

Interventions

ganitumab; Etoposide; rilotumumab; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: November 14, 2008
• Study Start: December 2, 2008
• Primary Completion: February 2, 2010
• Study Completion: May 1, 2013
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08