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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02125461
First received: April 25, 2014
Last updated: June 22, 2017
Last verified: June 2017
April 25, 2014
June 22, 2017
May 7, 2014
February 13, 2017   (Final data collection date for primary outcome measure)
  • Overall Survival (OS) [ Time Frame: Estimated to be from baseline up to 5 years ]
    Overall Survival is defined as the time from the date of randomization until death due to any cause.
  • Progression Free Survival (PFS) [ Time Frame: Estimated to be from baseline up to 5 years ]
    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).
  • Overall Survival (OS) [ Time Frame: Estimated to be from baseline up to 5 years ]
    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 ]
    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).
Complete list of historical versions of study NCT02125461 on ClinicalTrials.gov Archive Site
  • Overall Survival at 24 months (OS24) [ Time Frame: Estimated to be from baseline up to 5 years ]
    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) [ Time Frame: Estimated to be up to 3 years ]
    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) [ Time Frame: Estimated to be up to 3 years ]
    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) [ Time Frame: Estimated to be up to 3 years ]
    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) [ Time Frame: Estimated to be up to 3 years ]
    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.
  • Time to death or distant metastasis (TTDM) [ Time Frame: Estimated to be up to 5 years ]
    TTDM is defined as any new lesion that is outside of the radiaiton field.
  • Overall Survival at 24 months (OS24) [ Time Frame: Estimated to be from baseline up to 5 years ]
    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 ]
    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 ]
    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 ]
    APF12 is defined as the number (%) of patietns 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 ]
    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.
Not Provided
Not Provided
 
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
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)
A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.
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)
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: MEDI4736
    MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
  • Other: PLACEBO
    PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
  • Experimental: MEDI4736
    MEDI4736 (intravenous infusion)
    Intervention: Drug: MEDI4736
  • Placebo Comparator: PLACEBO
    Placebo (matching placebo for intravenous infusion)
    Intervention: Other: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
713
July 9, 2019
February 13, 2017   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Chile,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Vietnam
Argentina,   Brazil,   Philippines,   Russian Federation
 
NCT02125461
D4191C00001
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Haiyi Jiang, MD AstraZeneca
AstraZeneca
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP