Clinical trial NCT02259582: A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
Official title: A 2-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus Truncated Demcizumab as First-Line Treatment in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonsquamous Nonsmall Cell Neoplasm of Lung
Keywords: Phase 2
histologically
confirmed
malignancy
metastatic
pemetrexed
carboplatin
carcinoma
non small cell lung
lung neoplasms
lung diseases
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2014-10-08
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.

Detailed description: Patients will be enrolled at centers in North America, Western Europe, Australia and New Zealand. Up to 28 days (4 weeks) prior to treatment.

If enrolled in the study, you will receive intravenous (in the vein) infusions of demcizumab (or placebo), carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has gotten worse. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. After 8 cycles, if you have stable or improved disease, you may receive demcizumab (or placebo), every 21 days for 4 more cycles.

You will undergo assessments every 6 weeks to determine the status of your disease.

Eligibility criteria: Main Inclusion Criteria:

1. Signed Informed Consent Form
2. Histologically or cytologically confirmed Stage IV non-squamous NSCLC
3. Availability of FFPE (formalin-fixed paraffin-embedded) tumor tissue, either fresh core-needle-biopsied or archived
4. Age \> or = to 21 years
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
6. Disease that is measurable per RECIST v1.1
7. Adequate organ and marrow function
8. For women of childbearing potential, agreement to use two effective forms of contraception

Main Exclusion Criteria:

1. Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
2. NSCLC with known EGFR (epidermal growth factor receptor ) mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4 \[echinoderm microtubule-associated protein-like 4\]-ALK \[anaplastic lymphoma kinase\])
3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous NSCLC
4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
6. Malignancies other than non-squamous NSCLC successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
7. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
8. Significant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this study
9. Recent hemoptysis \>2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study

Primary outcomes:
measure: To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
timeFrame: Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Binghamton
country: United States
facility: Broome Oncology, LLC
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Gastonia
country: United States
facility: Gaston Hematology & Oncology
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Sherman
country: United States
facility: Texas Oncology-Sherman
state: Texas
city: Vancouver
country: United States
facility: Compass Oncology
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: The Kinghorn Cancer Centre
state: New South Wales
city: Port Macquarie
country: Australia
facility: North Coast Cancer Institute Port Macquarie Base Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royall Brisbane & Women's Hospital
state: Queensland
city: Milton
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Bentleigh East
country: Australia
facility: Monash Health, Monash Cancer Centre-Moorabbin
state: Victoria
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hospital
state: Western Australia
city: Antwerpen
country: Belgium
facility: Ziekenhuisnetwerk Antwerpen- Koningin Paola Kinderzickenhuis
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi- Site Notre-Dame
city: La Louviere
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
city: Liege
country: Belgium
facility: CHR de Ia Citadelle
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
state: Piemonte
city: Aviano
country: Italy
facility: Smilow Cancer Hospital at Yale-New Haven
state: Pordenone
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Avila
country: Spain
facility: Hospital Nuestra Senora de Sonsoles
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Institute Catalan de Oncologia (ICO L'Hospitalet)
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Madrid Universitario Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References: