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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)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MEDI4736

PLACEBO

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Locally advanced, Unresectable Non-Small Cell Lung Cancer, MEDI4736, PD-L1, Stage III Non-Small Cell Lung Cancer, Chemoradiation, Immune-mediated cancer therapy

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
Active or prior autoimmune disease or history of immunodeficiency.
Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MEDI4736

PLACEBO

Arm Description

MEDI4736 (intravenous infusion)

Placebo (matching placebo for intravenous infusion)

Outcomes

Primary Outcome Measures

Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

PFS was 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). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.

Overall Survival

OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.

Secondary Outcome Measures

Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1

ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.

Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1

DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.

Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1

APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.

Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1

APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.

Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1

TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.

Percentage of Patients Alive at 24 Months (OS24)

OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.

Time to Second Progression or Death (PFS2)

PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.

Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)

Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique.

Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)

The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.

Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.

Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.

Full Information

NCT ID

NCT02125461

First Posted

April 25, 2014

Last Updated

September 21, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02125461

Brief Title

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

Acronym

PACIFIC

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 7, 2014 (Actual)

Primary Completion Date

February 13, 2017 (Actual)

Study Completion Date

August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Locally advanced, Unresectable Non-Small Cell Lung Cancer, MEDI4736, PD-L1, Stage III Non-Small Cell Lung Cancer, Chemoradiation, Immune-mediated cancer therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

713 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEDI4736

Arm Type

Experimental

Arm Description

MEDI4736 (intravenous infusion)

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

Placebo (matching placebo for intravenous infusion)

Intervention Type

Drug

Intervention Name(s)

MEDI4736

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

PLACEBO

Intervention Description

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).

Primary Outcome Measure Information:

Title

Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Description

Time Frame

Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.

Title

Overall Survival

Description

OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.

Time Frame

From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1

Description

Time Frame

Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

Title

Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1

Description

Time Frame

Title

Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1

Description

APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.

Time Frame

Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.

Title

Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1

Description

APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.

Time Frame

Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.

Title

Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1

Description

Time Frame

Title

Percentage of Patients Alive at 24 Months (OS24)

Description

OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.

Time Frame

From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

Title

Time to Second Progression or Death (PFS2)

Description

Time Frame

Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

Title

Description

Time Frame

At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.

Title

Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)

Description

Time Frame

Title

Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

Description

Time Frame

Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.

Title

Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Description

Time Frame

Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age at least 18 years. Documented evidence of NSCLC (locally advanced, unresectable, Stage III) Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy. World Health Organisation (WHO) Performance Status of 0 to 1. Estimated life expectancy of more than 12 weeks. Exclusion Criteria: Prior exposure to any anti-PD-1 or anti-PD-L1 antibody. Active or prior autoimmune disease or history of immunodeficiency. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phil Dennis, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Research Site

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

Facility Name

Research Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72405

Country

United States

Facility Name

Research Site

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

Research Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Research Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Research Site

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Research Site

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Research Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Research Site

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Research Site

City

Fort Gordon

State/Province

Georgia

ZIP/Postal Code

30905

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Research Site

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50701

Country

United States

Facility Name

Research Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Research Site

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Research Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Research Site

City

Rosedale

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Research Site

City

Salisbury

State/Province

Maryland

ZIP/Postal Code

21801

Country

United States

Facility Name

Research Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55426

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Research Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11041

Country

United States

Facility Name

Research Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site

City

Pinehurst

State/Province

North Carolina

ZIP/Postal Code

28374

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Research Site

City

Blue Ash

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Research Site

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-8805

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Research Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99218

Country

United States

Facility Name

Research Site

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

Research Site

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Research Site

City

Bendigo

ZIP/Postal Code

3550

Country

Australia

Facility Name

Research Site

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Research Site

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

Facility Name

Research Site

City

Herston

ZIP/Postal Code

4029

Country

Australia

Facility Name

Research Site

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Research Site

City

Launceston

ZIP/Postal Code

7250

Country

Australia

Facility Name

Research Site

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

Port Macquarie

ZIP/Postal Code

2444

Country

Australia

Facility Name

Research Site

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Research Site

City

Westmead

ZIP/Postal Code

2145

Country

Australia

Facility Name

Research Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Research Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Research Site

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Libramont-Chevigny

ZIP/Postal Code

6800

Country

Belgium

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Research Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Research Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Facility Name

Research Site

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Research Site

City

Toronto

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7500000

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Research Site

City

Viña del Mar

Country

Chile

Facility Name

Research Site

City

Avignon Cedex 9

ZIP/Postal Code

84918

Country

France

Facility Name

Research Site

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Research Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Research Site

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

Research Site

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Research Site

City

Montpellier Cedex

ZIP/Postal Code

34295

Country

France

Facility Name

Research Site

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

Research Site

City

Nice

ZIP/Postal Code

06100

Country

France

Facility Name

Research Site

City

Pau cedex

ZIP/Postal Code

6400

Country

France

Facility Name

Research Site

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Research Site

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Research Site

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Research Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Research Site

City

Esslingen

ZIP/Postal Code

73730

Country

Germany

Facility Name

Research Site

City

Grosshansdorf

ZIP/Postal Code

20927

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Research Site

City

Löwenstein

ZIP/Postal Code

74245

Country

Germany

Facility Name

Research Site

City

Recklinghausen

ZIP/Postal Code

45659

Country

Germany

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Research Site

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Research Site

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Research Site

City

Gyula

ZIP/Postal Code

5703

Country

Hungary

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Research Site

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Research Site

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Research Site

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Research Site

City

Habikino-shi

ZIP/Postal Code

583-8588

Country

Japan

Facility Name

Research Site

City

Hidaka-shi

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Research Site

City

Hirakata-shi

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

730-8518

Country

Japan

Facility Name

Research Site

City

Kanazawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kashiwa

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Research Site

City

Kitaadachi-gun

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Research Site

City

Natori-shi

ZIP/Postal Code

981-1293

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Research Site

City

Osakasayama

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Research Site

City

Ota-shi

ZIP/Postal Code

373-8550

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Research Site

City

Sakai-shi

ZIP/Postal Code

591-8555

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Research Site

City

Sendai-shi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Takatsuki-shi

ZIP/Postal Code

569-8686

Country

Japan

Facility Name

Research Site

City

Ube-shi

ZIP/Postal Code

755-0241

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0051

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

361-711

Country

Korea, Republic of

Facility Name

Research Site

City

Hwasun-gun

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

UNK

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Research Site

City

Cuautitlan Izcalli

ZIP/Postal Code

54769

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Research Site

City

Orizaba

ZIP/Postal Code

94300

Country

Mexico

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Research Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Research Site

City

Eindhoven

ZIP/Postal Code

5623EJ

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Research Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Research Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Research Site

City

Bardejov

ZIP/Postal Code

08501

Country

Slovakia

Facility Name

Research Site

City

Kosice

ZIP/Postal Code

041 91

Country

Slovakia

Facility Name

Research Site

City

Nove Zamky

ZIP/Postal Code

94002

Country

Slovakia

Facility Name

Research Site

City

Trnava

ZIP/Postal Code

91775

Country

Slovakia

Facility Name

Research Site

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Research Site

City

Vereeniging

ZIP/Postal Code

1930

Country

South Africa

Facility Name

Research Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Research Site

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Research Site

City

Lérida

ZIP/Postal Code

25198

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28005

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Research Site

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Taipei City

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Research Site

City

Taipei

Country

Taiwan

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Research Site

City

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Research Site

City

Muang

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34030

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34844

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Research Site

City

Konya

ZIP/Postal Code

42080

Country

Turkey

Facility Name

Research Site

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

35247871

Citation

Senan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2.

Results Reference

derived

PubMed Identifier

35245844

Citation

Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9.

Results Reference

derived

PubMed Identifier

35108059

Citation

Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2. Erratum In: J Clin Oncol. 2022 Jun 10;40(17):1965.

Results Reference

derived

PubMed Identifier

34484473

Citation

Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021.

Results Reference

derived

PubMed Identifier

34294595

Citation

Socinski MA, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12.

Results Reference

derived

PubMed Identifier

33583206

Citation

Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Ozguroglu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Ryden A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15.

Results Reference

derived

PubMed Identifier

33545688

Citation

Mehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.

Results Reference

derived

PubMed Identifier

33476803

Citation

Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

Results Reference

derived

PubMed Identifier

33285469

Citation

Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.

Results Reference

derived

PubMed Identifier

32209338

Citation

Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.

Results Reference

derived

PubMed Identifier

31622733

Citation

Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.

Results Reference

derived

PubMed Identifier

31601496

Citation

Hui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Ryden A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.

Results Reference

derived

PubMed Identifier

30280658

Citation

Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

Results Reference

derived

PubMed Identifier

28885881

Citation

Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

Results Reference

derived

Links:

URL

http://www.emergingmed.com/networks/AstraZeneca

Description

AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com 1-877-400-465

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4191C00001&attachmentIdentifier=5253288a-15c6-48e2-a5b4-20315b70234e&fileName=D4191C00001-CSR_synopsis_redacted.pdf&versionIdentifier=

Description

CSR redacted synopsis

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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

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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)

Non-Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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