A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02125461
First received: April 25, 2014
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: MEDI4736
Other: PLACEBO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Estimated to be from baseline up to 5 years ] [ Designated as safety issue: No ]
    Overall Survival is defined as the time from the date of randomization until death due to any cause.

  • Progression Free Survival (PFS) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be from baseline up to 5 years ] [ Designated as safety issue: No ]
    Progression-Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).


Secondary Outcome Measures:
  • Overall Survival at 24 months (OS24) [ Time Frame: Estimated to be from baseline up to 5 years ] [ Designated as safety issue: No ]
    OS24 is defined as the number (%) of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months.

  • Duration of Response (DoR) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] [ Designated as safety issue: No ]
    DoR is defined as the time from date for first documented response of Complete Response (CR) or Partial Response (PR) until the first documented response of progression per RECIST 1.1 or death in the absence of progression.

  • Objective Response Rate (ORR) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] [ Designated as safety issue: No ]
    ORR is defined as the number (%) of patients with at least one visit response of Complete Response (CR) or partial response (PR) per RECIST 1.1.

  • Proportion of patients alive and progression free at 12 months from (APF12) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] [ Designated as safety issue: No ]
    APF12 is defined as the number (%) of patients who are alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of progression free survival at 12 months.

  • Proportion of patients alive and progression free at 18 months from(APF18) using investigational site assessments according to RECIST 1.1 [ Time Frame: Estimated to be up to 3 years ] [ Designated as safety issue: No ]
    APF18 is defined as the number (%) of patients who are alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of progression free survival at 18 months.


Estimated Enrollment: 702
Study Start Date: May 2014
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736
MEDI4736 (intravenous infusion)
Drug: MEDI4736
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Placebo Comparator: PLACEBO
Placebo (matching placebo for intravenous infusion)
Other: PLACEBO
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier

Detailed Description:

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at least 18 years.
  2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
  3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
  4. World Health Organisation (WHO) Performance Status of 0 to 1.
  5. Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

  1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
  2. Active or prior autoimmune disease or history of immunodeficiency.
  3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
  5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
  6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125461

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: Cancer Study Locator 877 400 4656 AstraZeneca@emergingmed.com

  Show 143 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Marc Ballas, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02125461     History of Changes
Other Study ID Numbers: D4191C00001
Study First Received: April 25, 2014
Last Updated: September 15, 2014
Health Authority: ARGENTINA : Administracion Nacional de Alimentos, Medicamentos y Tecnología Médica (ANMAT)
AUSTRALIA: Therapeutic Goods Administration (TGA)
AUSTRIA: AGES, Austrian Medicines and Medical Devices Agency - Austrian Federal Office for Safety in Health Care
BELGIUM: FAMHP, Federal agency for medicines and health products
BRAZIL: Agência Nacional de Vigilância Sanitária - Anvisa
Canada: Health Canada
CHILE: Instituto de Salud Pública (ISP) de Chile
FRANCE: ANSM, The French National Agency for Medicines and Health Products Safety
GERMANY: Here it will be PEI, Paul-Ehrlich Institut - Federal Institute for Vaccines and Biomedicines
GREECE: National Organization for Medicines
HUNGARY: OGYI, National Institute of Pharmacy
ITALY: AIFA, Italian Medicines Agency
JAPAN: PMDA, Pharmaceuticals and Medical Devices Agency
REPUBLIC OF KOREA: KFDA, Korea Food and Drug Administration
MEXICO: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
NETHERLANDS: Central Committee on Research Involving Human Subjects (CCMO)
NEW ZEALAND: Ministry of Health (MoH)
PERU: Instituto Nacional de Salud (INS)
PHILIPPINES: Food & Drugs Administration, DOH, Department of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
SPAIN: Spanish Agency of Medicines and Medical Devices
TAIWAN: Food and Drug Administration, Department of Health, Executive Yuan
THAILAND: Food and Drug Administration Thailand (FDA Thailand)
TURKEY: Ministry of Health, Drug and Pharmaceuticals Directorate
UKRAINE: Public Enterprise "The State Expert Center of the Ministry of Health of Ukraine"
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
VIETNAM: Ministry of Health's Administration of Science, Technology and Training (ASTT)

Keywords provided by AstraZeneca:
Locally advanced
Unresectable Non-Small Cell Lung Cancer
MEDI4736
PD-L1
Stage III Non-Small Cell Lung Cancer
Chemoradiation
Immune-mediated cancer therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014