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Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (ORION)

Primary Purpose

Non-small Cell Lung Cancer NSCLC

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Durvalumab

Placebo for Olaparib

Olaparib

Nab-paclitaxel+carboplatin

Gemcitabine+carboplatin

Pemetrexed+carboplatin

Gemcitabine+cisplatin

Pemetrexed+cisplatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer NSCLC focused on measuring NSCLC, Durvalumab, Olaparib, Maintenance, Homologous Recombination Repair (HRR)

Eligibility Criteria

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

Inclusion Criteria:

- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation.

Patients must have tumors that lack activating EGFR mutations and ALK fusions.

(WHO)/(ECOG) performance status of 0 or 1
No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
Adequate organ and marrow function without blood transfusions in the past 28 days,
At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1.

Key Inclusion criteria for randomization to maintenance treatment:

Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy.
Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection.
Ability to swallow whole oral medications.
All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken <3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit.

Exclusion criteria

Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology.
Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) therapy, or immunomediated therapy
Active or prior documented autoimmune or inflammatory disorders.
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP)
untreated (CNS) metastases and/or carcinomatous meningitis
Active infection.

Exclusion criteria to be randomized to maintenance treatment:

• Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Durvalumab/Olaparib Combination Therapy

Durvalumab Monotherapy

Arm Description

Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)

Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)

Outcomes

Primary Outcome Measures

Progression-free Survival

Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1. PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).

Secondary Outcome Measures

Overall Survival

Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause

Objective Response Rate

Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization

Duration of Response

Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression. Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.

Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population

Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).

Concentration of Durvalumab

Concentration (pharmacokinetics) of durvalumab

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.

Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13. Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.

Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.

Presence of Anti-drug Antibodies (ADAs) for Durvalumab

Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab

Number of Participants With Treatment-Related Adverse Events

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Full Information

NCT ID

NCT03775486

First Posted

November 27, 2018

Last Updated

October 16, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03775486

Brief Title

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

Acronym

ORION

Official Title

A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 21, 2018 (Actual)

Primary Completion Date

January 11, 2021 (Actual)

Study Completion Date

September 29, 2024 (Anticipated)

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

This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Detailed Description

Adult patients with a histologically or cytologically documented advanced NSCLC not amenable to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK fusions are eligible for enrollment. During the initial therapy phase, patients will receive treatment with Durvalumab along with the Investigator's choice of platinum-based doublet therapy for squamous NSCLC (nab-paclitaxel plus carboplatin or gemcitabine plus carboplatin/cisplatin) and non-squamous NSCLC (nab-paclitaxel plus carboplatin or pemetrexed plus carboplatin/cisplatin) for 4 cycles. Patients who have completed 4 cycles and not progressed throughout the initial therapy phase will be randomized in a 1:1 ratio into the maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus Olaparib maintenance therapy. Patients will receive maintenance treatment until specific discontinuation criteria are met, including clinical disease progression (as assessed by the Investigator) or RECIST 1.1-defined radiological Progressive Disease (PD), unacceptable toxicity, and withdrawal of consent. Tumor evaluation scans will be performed until objective disease progression as efficacy assessments. All patients will be followed for survival until the end of the study.

6. Conditions and Keywords

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

Non-small Cell Lung Cancer NSCLC

Keywords

NSCLC, Durvalumab, Olaparib, Maintenance, Homologous Recombination Repair (HRR)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Durvalumab/Olaparib Combination Therapy

Arm Type

Experimental

Arm Description

Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)

Arm Title

Durvalumab Monotherapy

Arm Type

Experimental

Arm Description

Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Other Intervention Name(s)

MEDI4736 (Durvalumab)

Intervention Description

Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.

Intervention Type

Drug

Intervention Name(s)

Placebo for Olaparib

Other Intervention Name(s)

Placebo

Intervention Description

Matching tablet

Intervention Type

Drug

Intervention Name(s)

Olaparib

Other Intervention Name(s)

AZD2281 (Olaparib)

Intervention Description

150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel+carboplatin

Intervention Description

Standard of Care chemotherapy (squamous and non-squamous patients)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine+carboplatin

Intervention Description

Standard of Care chemotherapy (squamous patients only)

Intervention Type

Drug

Intervention Name(s)

Pemetrexed+carboplatin

Intervention Description

Standard of Care chemotherapy (non-squamous patients only)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine+cisplatin

Intervention Description

Standard of Care chemotherapy (squamous patients only)

Intervention Type

Drug

Intervention Name(s)

Pemetrexed+cisplatin

Intervention Description

Standard of Care chemotherapy (non-squamous patients only)

Primary Outcome Measure Information:

Title

Progression-free Survival

Description

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause

Time Frame

From randomization until the date of death due to any cause, up to 18 months.

Title

Objective Response Rate

Description

Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Title

Duration of Response

Description

Time Frame

From date of first documented response until objective radiological disease progression or death, up to 18 months.

Title

Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population

Description

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Title

Concentration of Durvalumab

Description

Concentration (pharmacokinetics) of durvalumab

Time Frame

Assessed from start of initial therapy up to 2 years.

Title

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

Description

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Title

Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

Description

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Title

Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

Description

Time Frame

Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.

Title

Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

Description

Time Frame

From randomization until date of first symptom deterioration that is confirmed, up to 18 months.

Title

Presence of Anti-drug Antibodies (ADAs) for Durvalumab

Description

Time Frame

Assessed from start of initial therapy up to 2 years.

Title

Number of Participants With Treatment-Related Adverse Events

Description

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Time Frame

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

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: - Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. Patients must have tumors that lack activating EGFR mutations and ALK fusions. (WHO)/(ECOG) performance status of 0 or 1 No prior chemotherapy or any other systemic therapy for Stage IV NSCLC Adequate organ and marrow function without blood transfusions in the past 28 days, At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment: Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection. Ability to swallow whole oral medications. All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken <3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit. Exclusion criteria Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) therapy, or immunomediated therapy Active or prior documented autoimmune or inflammatory disorders. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP) untreated (CNS) metastases and/or carcinomatous meningitis Active infection. Exclusion criteria to be randomized to maintenance treatment: • Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myung-Ju Ahn, MD

Organizational Affiliation

Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Bonita Springs

State/Province

Florida

ZIP/Postal Code

34135

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

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308-5304

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Research Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

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

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Research Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Research Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Research Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Research Site

City

Farkasgyepü

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Research Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Research Site

City

Ahmedabad

ZIP/Postal Code

380009

Country

India

Facility Name

Research Site

City

Ahmedabad

ZIP/Postal Code

380053

Country

India

Facility Name

Research Site

City

Jamnagar

ZIP/Postal Code

361008

Country

India

Facility Name

Research Site

City

Kochi

ZIP/Postal Code

682026

Country

India

Facility Name

Research Site

City

Mysuru

ZIP/Postal Code

570021

Country

India

Facility Name

Research Site

City

Nashik

ZIP/Postal Code

422004

Country

India

Facility Name

Research Site

City

Nashik

ZIP/Postal Code

422005

Country

India

Facility Name

Research Site

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Research Site

City

Thiruvananthapuram

ZIP/Postal Code

695011

Country

India

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Kanazawa-shi

ZIP/Postal Code

920-8641

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

Sendai-shi

ZIP/Postal Code

980-0873

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Ube-shi

ZIP/Postal Code

755-0241

Country

Japan

Facility Name

Research Site

City

Dongjakgu

ZIP/Postal Code

07061

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seodaemun-gu

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

Suweonsi Paldalgu

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Research Site

City

Chihuahua

ZIP/Postal Code

31200

Country

Mexico

Facility Name

Research Site

City

Culiacan

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Research Site

City

San Luis Potosí

ZIP/Postal Code

78250

Country

Mexico

Facility Name

Research Site

City

Blaricum

ZIP/Postal Code

1261

Country

Netherlands

Facility Name

Research Site

City

Harderwijk

ZIP/Postal Code

3844

Country

Netherlands

Facility Name

Research Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

Research Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Research Site

City

Prabuty

ZIP/Postal Code

82-550

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Research Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454092

Country

Russian Federation

Facility Name

Research Site

City

Kursk

ZIP/Postal Code

305524

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Nal'chik

ZIP/Postal Code

360000

Country

Russian Federation

Facility Name

Research Site

City

P. Herzen Moscow Oncology Rese

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Research Site

City

Sochi

ZIP/Postal Code

354000

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Research Site

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Research Site

City

Kharkiv Region

ZIP/Postal Code

61024

Country

Ukraine

Facility Name

Research Site

City

Kirovohrad

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

Research Site

City

Odesa

ZIP/Postal Code

65055

Country

Ukraine

Facility Name

Research Site

City

Uzhhorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhia

ZIP/Postal Code

69059

Country

Ukraine

Facility Name

Research Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Research Site

City

Hull

ZIP/Postal Code

HU6 7RX

Country

United Kingdom

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.

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 de-identified 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

Links:

URL

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Learn more about this trial

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

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Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (ORION)

Non-small Cell Lung Cancer NSCLC

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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