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Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

Primary Purpose

Small Cell Lung Carcinoma Extensive Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Durvalumab plus chemotherapy
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma Extensive Disease

Eligibility Criteria

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

For inclusion in the study, patients should fulfill the following criteria:

  1. Male or female ≥18 years at the time of Screening.
  2. Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  3. Histologically or cytologically documented extensive stage SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, according to American Joint Committee on Cancer Stage 8th edition).

    - Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.

  4. Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
  5. Life expectancy ≥12 weeks at Day 1.
  6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at enrollment.

    - Note: Patients with PS2 will be limited to a maximum of 20% of the total study population; once this limit is met, additional enrolled patients must have PS 0-1.

  7. Body weight >30 kg.
  8. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
  9. Baseline CT/MRI results of the chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation.
  10. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
  11. Adequate organ and marrow function as defined below (test can be repeated once if necessary):

    • Hemoglobin ≥9.0 g/dL.
    • Absolute neutrophil count ≥1.5 × 10^9/L (use of granulocyte colony-stimulating factor is not permitted at within 7 days before testingscreening).
    • Platelet count ≥100 × 10^9/L.
    • Serum bilirubin ≤1.5 × the upper limit of normal (ULN).
    • In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN.
    • In patients with hepatic metastases, ALT and AST ≤5 × ULN.
    • Measured or calculated creatinine clearance: >60mL/min for patients planned to be treated with cisplatin and >40mL/min for patients planned to be treated with carboplatin
  12. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

The following age-specific requirements apply:

  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Previous IP assignment in the present study.
  2. Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy.
  3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  4. Received prior systemic therapy for ES-SCLC. Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC
  5. Any condition that, in the opinion of the treating physician, would interfere with evaluation of the study drug or interpretation of patient safety.
  6. Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (ie, bone metastasis) is allowed but must be completed before first dose of the study medication.
  7. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  8. History of allogeneic organ transplantation.
  9. Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS.
  10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc]). The following are exceptions to this criterion:

    • Patients with vitiligo or alopecia
    • Patients with hypothyroidism (eg, following Hashimoto syndrome) and stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
    • Patients with celiac disease controlled by diet alone
  11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  12. History of active primary immunodeficiency.
  13. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HbsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

    • Intranasal, inhaled, topical steroids or local steroid injections (eg, intra articular
    • injection).
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
    • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). Premedication with steroids for chemotherapy is acceptable.
  15. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  16. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from Screening to 90 days after the last dose of durvalumab.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Durvalumab plus 4-6 cycles chemotherapy

Arm Description

Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.

Outcomes

Primary Outcome Measures

Incidence of Grade ≥3 AE and Incidence of imAE

Secondary Outcome Measures

Pogression-free survival (PFS) using investigator assessments according to RECIST 1.1
Kaplan-Meier estimate of PFS curve, including quartiles (when estimable) and PFS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.
Proportion of patients alive and progression free at 12 months after first dose of study treatment (APF12)
Kaplan-Meier estimate of the PFS curve at 12 months, together with confidence interval.
Objective response rate (ORR) using investigator assessments according to RECIST 1.1
The proportion of subjects with an objective response, including confidence interval.
Duration of Response (DoR)
For responders only, the Kaplan Meier curve of DoR including quartiles and DoR at landmark times. All estimates will be accompanied by the appropriate confidence interval.
Overall survival (OS)
Kaplan-Meier estimate of OS curve, including quartiles (when estimable) and OS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.
Overall survival at 12 months (OS12) after first dose of study treatment
Kaplan-Meier estimate of the OS curve at 12 months, together with confidence interval
AE (including all AEs, SAEs, adverse event of special interest [AESI], AE resulting in treatment discontinuation)
Estimates of the incidence of AEs overall, and by different categories of AE

Full Information

First Posted
May 6, 2020
Last Updated
July 21, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04449861
Brief Title
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)
Official Title
An Open Label, Multicenter Study of First-Line Durvalumab Plus Platinum-Based Chemotherapy in Chinese Patients With Extensive Stage Small-Cell Lung Cancer (Oriental)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma Extensive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durvalumab plus 4-6 cycles chemotherapy
Arm Type
Experimental
Arm Description
Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.
Intervention Type
Drug
Intervention Name(s)
Durvalumab plus chemotherapy
Intervention Description
Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin 4-6 cycles every 3 weeks Drug: Cisplatin 4-6 cycles every 3 weeks Drug: Etoposide 4-6 cycles every 3 weeks
Primary Outcome Measure Information:
Title
Incidence of Grade ≥3 AE and Incidence of imAE
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Pogression-free survival (PFS) using investigator assessments according to RECIST 1.1
Description
Kaplan-Meier estimate of PFS curve, including quartiles (when estimable) and PFS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.
Time Frame
Up to 2 years
Title
Proportion of patients alive and progression free at 12 months after first dose of study treatment (APF12)
Description
Kaplan-Meier estimate of the PFS curve at 12 months, together with confidence interval.
Time Frame
Up to 12 months
Title
Objective response rate (ORR) using investigator assessments according to RECIST 1.1
Description
The proportion of subjects with an objective response, including confidence interval.
Time Frame
Up to 2 years
Title
Duration of Response (DoR)
Description
For responders only, the Kaplan Meier curve of DoR including quartiles and DoR at landmark times. All estimates will be accompanied by the appropriate confidence interval.
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
Kaplan-Meier estimate of OS curve, including quartiles (when estimable) and OS at landmark time-points. All estimates will be accompanied by the appropriate confidence interval.
Time Frame
Up to 2 years
Title
Overall survival at 12 months (OS12) after first dose of study treatment
Description
Kaplan-Meier estimate of the OS curve at 12 months, together with confidence interval
Time Frame
Up to 12 months
Title
AE (including all AEs, SAEs, adverse event of special interest [AESI], AE resulting in treatment discontinuation)
Description
Estimates of the incidence of AEs overall, and by different categories of AE
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For inclusion in the study, patients should fulfill the following criteria: Male or female ≥18 years at the time of Screening. Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. Histologically or cytologically documented extensive stage SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, according to American Joint Committee on Cancer Stage 8th edition). - Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry. Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide. Life expectancy ≥12 weeks at Day 1. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at enrollment. - Note: Patients with PS2 will be limited to a maximum of 20% of the total study population; once this limit is met, additional enrolled patients must have PS 0-1. Body weight >30 kg. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. Baseline CT/MRI results of the chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines. Adequate organ and marrow function as defined below (test can be repeated once if necessary): Hemoglobin ≥9.0 g/dL. Absolute neutrophil count ≥1.5 × 10^9/L (use of granulocyte colony-stimulating factor is not permitted at within 7 days before testingscreening). Platelet count ≥100 × 10^9/L. Serum bilirubin ≤1.5 × the upper limit of normal (ULN). In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN. In patients with hepatic metastases, ALT and AST ≤5 × ULN. Measured or calculated creatinine clearance: >60mL/min for patients planned to be treated with cisplatin and >40mL/min for patients planned to be treated with carboplatin Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). Patients should not enter the study if any of the following exclusion criteria are fulfilled: Previous IP assignment in the present study. Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. Received prior systemic therapy for ES-SCLC. Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC Any condition that, in the opinion of the treating physician, would interfere with evaluation of the study drug or interpretation of patient safety. Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (ie, bone metastasis) is allowed but must be completed before first dose of the study medication. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. History of allogeneic organ transplantation. Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc]). The following are exceptions to this criterion: Patients with vitiligo or alopecia Patients with hypothyroidism (eg, following Hashimoto syndrome) and stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician Patients with celiac disease controlled by diet alone Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. History of active primary immunodeficiency. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HbsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids or local steroid injections (eg, intra articular injection). Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). Premedication with steroids for chemotherapy is acceptable. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from Screening to 90 days after the last dose of durvalumab.
Facility Information:
Facility Name
Research Site
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130012
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116001
Country
China
Facility Name
Research Site
City
Dongyang
ZIP/Postal Code
322100
Country
China
Facility Name
Research Site
City
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510280
Country
China
Facility Name
Research Site
City
Haerbin
ZIP/Postal Code
150081
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230000
Country
China
Facility Name
Research Site
City
Huai'an
ZIP/Postal Code
223000
Country
China
Facility Name
Research Site
City
Jiangyin
ZIP/Postal Code
214400
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Research Site
City
Jinhua
ZIP/Postal Code
321099
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330000
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210032
Country
China
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315000
Country
China
Facility Name
Research Site
City
Qingdao
ZIP/Postal Code
266100
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Research Site
City
ShenZhen
ZIP/Postal Code
518020
Country
China
Facility Name
Research Site
City
Taizhou
ZIP/Postal Code
318000
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Research Site
City
Whenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225012
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China

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

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Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

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