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A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (PACIFIC-8)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Durvalumab

Domvanalimab

Placebo

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring non-small cell lung cancer, locally advanced, NSCLC

Eligibility Criteria

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

INCLUSION CRITERIA:

Participant must be ≥ 18 years at the time of screening.
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status ≥ 1% by central lab
Documented EGFR and ALK wild-type status (local or central).
Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function

EXCLUSION CRITERIA:

History of another primary malignancy except for malignancy treated with curative intent with no known active disease > 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy, adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease.
Mixed small cell and non-small cell lung cancer histology.
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, ILD, pleural effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization.
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Active EBV infection, or known or suspected chronic active EBV infection at screening
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Reproduction
Negative pregnancy test (serum) for WOCBP:
Female participants must be 1 year post menopausal, surgically sterile, or using 1 highly effective form of birth control
Male participants who intend to be sexually active with a WOCBP must be surgically sterile or using an acceptable method of contraception

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Durvalumab + Domvanalimab

Arm B: Durvalumab + Placebo

Arm Description

Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months

Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.

Secondary Outcome Measures

Progression Free Survival (PFS)

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%

Overall Survival (OS)

Objective Response Rate (ORR)

Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR

Duration of Response (DoR)

Duration of Response (DoR) using BICR assessment according to RECIST 1.1

Time from randomization to second progression (PFS2)

Time from randomization to first date of distant metastasis or death (TTDM)

Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).

Time to first subsequent therapy (TFST)

Concentration of Durvalumab and Domvanalimab

The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration

PFS6, PFS12, PFS18, PFS24

PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)

Anti-Drug Antibodies (ADAs)

The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)

Time to deterioration in pulmonary symptoms (TTFCD)

Full Information

NCT ID

NCT05211895

First Posted

January 11, 2022

Last Updated

October 6, 2023

Sponsor

AstraZeneca

Collaborators

Arcus Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05211895

Brief Title

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Acronym

PACIFIC-8

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2022 (Actual)

Primary Completion Date

June 2, 2027 (Anticipated)

Study Completion Date

September 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Arcus Biosciences, Inc.

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

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

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

non-small cell lung cancer, locally advanced, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Durvalumab + Domvanalimab

Arm Type

Experimental

Arm Description

Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months

Arm Title

Arm B: Durvalumab + Placebo

Arm Type

Active Comparator

Arm Description

Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Intervention Description

Durvalumab IV (Intravenous infusion)

Intervention Type

Drug

Intervention Name(s)

Domvanalimab

Intervention Description

Domvanalimab IV (Intravenous infusion)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo IV (Intravenous infusion)

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.

Time Frame

Up to 8 years after first patient randomised

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%

Time Frame

Up to 8 years after first patient randomised

Title

Overall Survival (OS)

Description

Overall Survival (OS)

Time Frame

Approximately 8 years after first patient randomized

Title

Objective Response Rate (ORR)

Description

Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR

Time Frame

Approximately 8 years after first patient randomized

Title

Duration of Response (DoR)

Description

Duration of Response (DoR) using BICR assessment according to RECIST 1.1

Time Frame

Approximately 8 years after first patient randomized

Title

Time from randomization to second progression (PFS2)

Description

Time from randomization to second progression (PFS2)

Time Frame

Approximately 8 years after first patient randomized

Title

Time from randomization to first date of distant metastasis or death (TTDM)

Description

Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).

Time Frame

Approximately 8 years after first patient randomized

Title

Time to first subsequent therapy (TFST)

Description

Time to first subsequent therapy (TFST)

Time Frame

Approximately 8 years after first patient randomized

Title

Concentration of Durvalumab and Domvanalimab

Description

The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration

Time Frame

Approximately 12 weeks after last IP dose

Title

PFS6, PFS12, PFS18, PFS24

Description

PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)

Time Frame

Approximately 6, 12, 18 and 24 months after last patient randomized

Title

Anti-Drug Antibodies (ADAs)

Description

The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)

Time Frame

Approximately 12 weeks after last IP dose.

Title

Time to deterioration in pulmonary symptoms (TTFCD)

Description

Time to deterioration in pulmonary symptoms (TTFCD)

Time Frame

Approximately 8 years after first patient randomized

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Participant must be ≥ 18 years at the time of screening. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease Provision of a tumour tissue sample obtained prior to CRT Documented tumour PD-L1 status ≥ 1% by central lab Documented EGFR and ALK wild-type status (local or central). Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. WHO performance status of 0 or 1 at randomization Adequate organ and marrow function EXCLUSION CRITERIA: History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease. Mixed small cell and non-small cell lung cancer histology. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia). Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis Active or prior documented autoimmune or inflammatory disorders (with exceptions) Active EBV infection, or known or suspected chronic active EBV infection at screening Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AstraZeneca Clinical Study Information Center

Phone

1-877-240-9479

information.center@astrazeneca.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hidehito Horinouchi, MD, PhD

Organizational Affiliation

National Cancer Center Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander Spira, MD, PhD

Organizational Affiliation

Virginia Cancer Specialists Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jinming Yu, MD, PhD

Organizational Affiliation

Shandong Cancer Hospital and Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31217

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Elmhurst

State/Province

Illinois

ZIP/Postal Code

60126

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Florham Park

State/Province

New Jersey

ZIP/Postal Code

07932

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28805

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fort Belvoir

State/Province

Virginia

ZIP/Postal Code

22060

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Spokane Valley

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brussels

ZIP/Postal Code

1160

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Haine-Saint-Paul

ZIP/Postal Code

7100

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Research Site

City

Londrina

ZIP/Postal Code

86015-520

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Porto Velho

ZIP/Postal Code

76834-899

Country

Brazil

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santo Andre

ZIP/Postal Code

09060-650

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01221-900

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01236-030

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

01310-000

Country

Brazil

Individual Site Status

Withdrawn

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04556-100

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taubaté

ZIP/Postal Code

12030-200

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Las Condes

ZIP/Postal Code

7560908

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Puerto Montt

ZIP/Postal Code

5500243

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7500713

Country

Chile

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7630370

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8241479

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Temuco

ZIP/Postal Code

4810218

Country

Chile

Individual Site Status

Recruiting

Facility Name

Research Site

City

Baoding

ZIP/Postal Code

071000

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Baotou

ZIP/Postal Code

140400

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Bengbu

ZIP/Postal Code

233060

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

430033

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Chongqing

ZIP/Postal Code

400042

Country

China

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Dalian

ZIP/Postal Code

116001

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Dongguan

ZIP/Postal Code

523009

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Foshan

ZIP/Postal Code

528000

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510120

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310009

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230001

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Jinan

ZIP/Postal Code

250014

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Jinan

ZIP/Postal Code

250021

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Ningbo

ZIP/Postal Code

315010

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Qingdao

ZIP/Postal Code

266042

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Shandong

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Shenzhen

ZIP/Postal Code

518036

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Suzhou

ZIP/Postal Code

215006

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Taiyuan

ZIP/Postal Code

030000

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300000

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Xi'an

ZIP/Postal Code

710061

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Xiamen

ZIP/Postal Code

361003

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Yinchuan

ZIP/Postal Code

750004

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Aix en Provence

ZIP/Postal Code

13616

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Angers

ZIP/Postal Code

49055

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bobigny

ZIP/Postal Code

93000

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59000

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Paris Cedex 14

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Pau cedex

ZIP/Postal Code

6400

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Quimper cedex

ZIP/Postal Code

29000

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Saint Gregoire

ZIP/Postal Code

35760

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Saint-Quentin cedex

ZIP/Postal Code

02321

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Vantoux

ZIP/Postal Code

57070

Country

France

Individual Site Status

Recruiting

Facility Name

Research Site

City

Villeurbanne

ZIP/Postal Code

69100

Country

France

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Berlin-Zehlendorf

ZIP/Postal Code

14165

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Chemnitz

ZIP/Postal Code

09116

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Georgsmarienhuette

ZIP/Postal Code

49124

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Halle

ZIP/Postal Code

06120

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Koblenz

ZIP/Postal Code

56073

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Krefeld

ZIP/Postal Code

47805

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Köln

ZIP/Postal Code

51109

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Löwenstein

ZIP/Postal Code

74245

Country

Germany

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Moers

ZIP/Postal Code

47441

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

München

ZIP/Postal Code

81675

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93049

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Athens

ZIP/Postal Code

18547

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Holargos, Athens

ZIP/Postal Code

155 62

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

55236

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

56 429

Country

Greece

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hong Kong

ZIP/Postal Code

150001

Country

Hong Kong

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Salgótarján

ZIP/Postal Code

3100

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ahmedabad

ZIP/Postal Code

380054

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bangalore

ZIP/Postal Code

560064

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Delhi

ZIP/Postal Code

110085

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Gurgaon

ZIP/Postal Code

122001

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Howrah

ZIP/Postal Code

711103

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hyderabad

ZIP/Postal Code

500032

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jaipur

ZIP/Postal Code

302022

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kolkata

ZIP/Postal Code

700160

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Marg Jaipur

ZIP/Postal Code

302004

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Mohali

ZIP/Postal Code

160055

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Namakkal

ZIP/Postal Code

637001

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110005

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8603

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8677

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chiba-shi

ZIP/Postal Code

260-8717

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

812-8582

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hidaka-shi

ZIP/Postal Code

350-1298

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hirosaki-shi

ZIP/Postal Code

036-8563

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

173-0003

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Kashihara-shi

ZIP/Postal Code

634-8522

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kumamoto-shi

ZIP/Postal Code

860-8556

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

545-8586

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Osakasayama-shi

ZIP/Postal Code

589-8511

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

221-0855

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Jinju-si

ZIP/Postal Code

52727

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

07061

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Name

Research Site

City

Johor Bahru

ZIP/Postal Code

81100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Kuching

ZIP/Postal Code

93586

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Selangor

ZIP/Postal Code

46050

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Research Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Cdmx

ZIP/Postal Code

03810

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44638

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sonora

ZIP/Postal Code

83207

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Veracruz

ZIP/Postal Code

91900

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Bodø

ZIP/Postal Code

8073

Country

Norway

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Gjøvik

ZIP/Postal Code

2819

Country

Norway

Individual Site Status

Recruiting

Facility Name

Research Site

City

Oslo

ZIP/Postal Code

0450

Country

Norway

Individual Site Status

Recruiting

Facility Name

Research Site

City

Trondheim

ZIP/Postal Code

0730

Country

Norway

Individual Site Status

Recruiting

Facility Name

Research Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Individual Site Status

Recruiting

Facility Name

Research Site

City

Muntinlupa City

ZIP/Postal Code

1780

Country

Philippines

Individual Site Status

Recruiting

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Individual Site Status

Recruiting

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1112

Country

Philippines

Individual Site Status

Recruiting

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-027

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Katowice

ZIP/Postal Code

40-074

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zielona Góra

ZIP/Postal Code

65-046

Country

Poland

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

93-513

Country

Poland

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

050098

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Iasi

ZIP/Postal Code

700483

Country

Romania

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Oradea

ZIP/Postal Code

410001

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Suceava

ZIP/Postal Code

720214

Country

Romania

Individual Site Status

Recruiting

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300166

Country

Romania

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Amanzimtoti

ZIP/Postal Code

4126

Country

South Africa

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Amanzimtoti

ZIP/Postal Code

4126

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Research Site

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0084

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Research Site

City

Bilbao (Vizcaya)

ZIP/Postal Code

48013

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Castello de la Plana

ZIP/Postal Code

12002

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

El Palmar

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Name

Research Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Hsinchu

ZIP/Postal Code

300

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

New-Taipei

ZIP/Postal Code

220216

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tainan

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Research Site

City

Adapazari

ZIP/Postal Code

54290

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06340

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

6100

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Antalya

ZIP/Postal Code

07058

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34662

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Konya

ZIP/Postal Code

42080

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Çankaya

ZIP/Postal Code

06680

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Cheltenham

ZIP/Postal Code

GL53 7AN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

High Heaton/Newcastle Upon Tyn

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS 9 7TF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

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A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (PACIFIC-8)

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

Learn more about this trial