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A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693300
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks [q4w] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Drug: Durvalumab Phase 2

Detailed Description:
This is a Phase II, open-label, multi-centre study to determine safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) monotherapy in participants with unresectable Stage III NSCLC who have not progressed following definitive, platinum-based sCRT. Approximately, 150 participants will be treated with the study drug in Europe and North America. Participants will be in complete response (CR), partial response (PR), or have stable disease (SD) following definitive, platinum-based sCRT, as assessed by the Investigator and further supported by the screening imaging radiological assessment. Participants must not have progressed following definitive, platinum-based sCRT; radiation therapy must be completed within 42 days prior to first Investigational product (IP) dose administration. Participants must have histologically- or cytologically-documented NSCLC and locally-advanced, unresectable Stage III disease. Participants will be treated with the study drug in 2 cohorts: approximately 100-120 participants in the World Health Organization/Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) 0 to 1 Cohort and up to 30 participants in the WHO/ECOG PS 2 Cohort.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6).
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 8, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: WHO/ECOG PS 0 to 1 Cohort
100-120 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Drug: Durvalumab
Participants will receive 1500 mg Durvalumab monotherapy via IV infusion q4w for up to a maximum of 24 months with the last administration at Week 104.
Other Name: MEDI4736

Experimental: WHO/ECOG PS 2 Cohort
up to 30 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Drug: Durvalumab
Participants will receive 1500 mg Durvalumab monotherapy via IV infusion q4w for up to a maximum of 24 months with the last administration at Week 104.
Other Name: MEDI4736




Primary Outcome Measures :
  1. Number of participants with Grade 3 and Grade 4 Treatment-related adverse events (TRAEs) [ Time Frame: From screening (Day -28) till final visit (upto a maximum of 24 months) ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) as defined by Grade 3 and Grade 4 TRAEs within 6 months from the initiation of durvalumab (MEDI4736) treatment


Secondary Outcome Measures :
  1. Median Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the Investigator [ Time Frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months) ]
    To assess the efficacy of Durvalumab (MEDI4736) treatment in terms of PFS. PFS will be calculated using Kaplan-Meier product limit methods.

  2. PFS at 12 months (PFS12) [ Time Frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 12 months) ]
    To assess the efficacy of Durvalumab (MEDI4736) treatment in terms of PFS. PFS will be calculated using Kaplan-Meier product limit methods.

  3. PFS at 24 months (PFS24) [ Time Frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months) ]
    To assess the efficacy of Durvalumab (MEDI4736) treatment in terms of PFS. PFS will be calculated using Kaplan-Meier product limit methods.

  4. Median overall survival (OS) [ Time Frame: From the first date of treatment until death due to any cause (up to maximum 24 months) ]
    To assess the efficacy of Durvalumab(MEDI4736) treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.

  5. OS at 12 months (OS12) [ Time Frame: From the first date of treatment until death due to any cause (up to maximum 12 months) ]
    To assess the efficacy of Durvalumab(MEDI4736) treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.

  6. OS at 24 months (OS24) [ Time Frame: From the first date of treatment until death due to any cause (up to maximum 24 months) ]
    To assess the efficacy of Durvalumab(MEDI4736) treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.

  7. OS at 36 months (OS36) [ Time Frame: From the first date of treatment until death due to any cause (up to maximum 36 months) ]
    To assess the efficacy of Durvalumab(MEDI4736) treatment in terms of OS. OS will be calculated using Kaplan-Meier product limit methods.

  8. Objective Response Rate (ORR) per RECIST 1.1 as assessed by the Investigator [ Time Frame: From 8 weeks ±1 week after investigational product (IP) treatment initiation and continue every 8 weeks (q8w) ±1 week through 52 weeks and every 12 weeks (q12w) ±1 week until disease progression (up to maximum of 24 months) ]
    To further assess the efficacy of Durvalumab (MEDI4736) treatment in terms of ORR. ORR (based on Investigator assessment by RECIST 1.1 criteria), together with the corresponding 95% CI, will be reported for participants.

  9. Duration of Response (DOR) per RECIST 1.1 as assessed by the Investigator [ Time Frame: From 8 weeks ±1 week after IP treatment initiation and continue q8w ±1 week through 52 weeks and q12w ±1 week until disease progression (up to maximum of 24 months) ]
    To further assess the efficacy of Durvalumab (MEDI4736) treatment in terms of DoR. DoR is defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.

  10. Number of participants with lung cancer mortality [ Time Frame: From date of treatment start until death due to lung cancer (up to maximum of 24 months) ]
    To assess the efficacy of durvalumab (MEDI4736) treatment in terms of lung cancer mortality.

  11. Number of participants with Adverse events (AEs), Serious adverse events (SAEs), Adverse event of special interests (AESIs), and Immune-mediated adverse event (imAEs) [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months) ]
    To further assess the safety and tolerability profile of Durvalumab(MEDI4736) treatment, including all AEs

  12. Number of participants with abnormal physical examinations [ Time Frame: At screening ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal physical examinations. Full physical examinations will include assessments of the head, eyes, ears, nose, and throat and the respiratory, cardiovascular, gastrointestinal (GI), urogenital, musculoskeletal, eurological, rmatological, haematologic/lymphatic, and endocrine systems.

  13. Number of participants with abnormal blood pressure (BP). [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months) ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal BP. BP will be collected before, during, and after IP infusion.

  14. Number of participants with abnormal pulse [ Time Frame: From screening (Day -28) till final visit (up to maximum of 24 months) ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal pulse. Pulse will be collected before, during, and after IP infusion.

  15. Number of participants with abnormal Electrocardiograms (ECGs) [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months) ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal ECGs. Resting 12-lead ECGs will be recorded at screening and as clinically indicated throughout the study. ECGs should be obtained after the participant has been in a supine position for 5 minutes and recorded while the participant remains in that position. In case of clinically significant ECG abnormalities, including a QT interval corrected for heart rate using Fridericia's formula (QTcF) value >470 ms, 2 additional 12-lead ECGs should be obtained over a brief period (eg, 30 minutes) to confirm the finding.

  16. Number of participants with abnormal clinical chemistry [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months) ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal clinical chemistry values. Blood and urine samples for determination of clinical chemistry will be taken at the times indicated in the assessment schedules and as clinically indicated. Abnormal clinically significant laboratory results should be repeated as soon as possible (preferably within 24 to 48 hours). The laboratory variables to be measured are: Albumin, Alkaline phosphatase, Alanine transaminase, Amylase, Aspartate transaminase, Lactate dehydrogenase, Lipase, Magnesium, Potassium, Sodium, Bicarbonate, Calcium, Chloride, Creatinine, Creatinine clearance, Gamma glutamyltransferase, Glucose, Total bilirubin, Total protein, Thyroid-stimulating hormone, T3 and T4 free (reflex), and Urea or blood urea nitrogen, depending on local practice. Other safety assessments to be performed at screening include HbsAg, hepatitis C antibodies, and HIV antibodies.

  17. Number of participants with abnormal haematology [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months)] ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal haematology values. The laboratory variables to be measured are: Absolute neutrophil count, Absolute lymphocyte count, Haemoglobin, Platelet count, Total white cell count, and Coagulation.

  18. Number of participants with abnormal urinalysis. [ Time Frame: From screening (Day -28) till final visit (up to a maximum of 24 months)] ]
    To assess the safety and tolerability profile of Durvalumab (MEDI4736) treatment in terms of the number of participants with abnormal urinalysis values. The laboratory variables to be measured are: Bilirubin, Ketones, Blood, pH, Colour and appearance, Protein, Glucose, and Specific gravity. Urinalysis should be done at baseline (screening) and then as clinically indicated.



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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
  3. Provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis (optional).
  4. 18 years or older at the time of signing the ICF.
  5. Histologically- or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
  6. Receipt of sCRT which must have been completed within 42 days prior to first IP dose administration in the study.

    1. The platinum-based chemotherapy regimen must contain cisplatin or carboplatin and 1 of the following agents: etoposide, vinblastine, vinorelbine, a taxane (paclitaxel or docetaxel), or pemetrexed, according to the local standard of care (SoC) regimens. Platinum-based chemotherapy containing cisplatin or carboplatin and gemcitabine is permitted under certain conditions - refer to bullet point 6(b).
    2. Patients must have received at least 2 cycles of platinum-based chemotherapy before radiation therapy. The interval between administration of the last dose of chemotherapy regimen and start of radiation therapy must be no more than 6 weeks. Consolidation chemotherapy after radiation is not permitted.

    (i) If the patient's platinum-based chemotherapy contained gemcitabine, no overlap between chemotherapy and radiation therapy is permitted.

    (ii) If the patient's platinum-based chemotherapy contained any of the agents listed in (a) other than gemcitabine, an overlap of 1 cycle of chemotherapy and radiation therapy is acceptable.

    (c) Patients must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy). Sites are encouraged to adhere to mean organ radiation dosing as follows: (i) Mean lung dose <20 Gy and/or V20 <35%; (ii) Mean oesophagus <34 Gy; (iii) Heart V45 <35% or V30 <30%. Note: Sites should be aware of the recent RTOG 0617 Study data demonstrating that doses higher than 60 Gy may be associated with greater toxicity and worse efficacy.

    (d) Patients with WHO/ECOG PS 2 or chronic lung disease (pulmonary emphysema or chronic obstructive pulmonary disease) must have received a V20 <25%.

  7. Patients must not have progressed following platinum-based sCRT, as per Investigator assessed RECIST 1.1 criteria. . In order to assess disease progression, the baseline imaging (CT/MRI) used for Screening purposes should be compared against the most recently performed scan that allows physician assessment as per RECIST 1.1 criteria. If an intermediate scan taken between chemotherapy and radiotherapy is available and that scan is suitable for physician assessment as per RECIST 1.1 criteria, then this scan should be used.

    1. Patients with measurable disease and/or non-measurable and/or no evidence of disease (NED) assessed at baseline by CT/MRI will be entered in this study.
    2. Prior irradiated lesions may be considered measurable and selected as TLs provided they fulfil the other criteria for measurability.
  8. Must have a life expectancy of at least 12 weeks at enrolment.
  9. WHO/ECOG PS ≤2.
  10. Adequate organ and marrow function at enrolment as defined below. These parameters should be achieved without augmentation by growth factors, transfusions, or infusions within 14 days of screening unless required for SoC:

    1. Haemoglobin ≥9.0 g/dL;
    2. Absolute neutrophil count >1.0 × 109/L;
    3. Platelet count >75 × 109/L;
    4. Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
    6. Measured creatinine clearance >40 mL/min or calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault (using actual body weight) (Cockcroft and Gault 1976).

Males:

Creatinine clearance (mL/min) = Weight (kg) × (140 Age) 72 × serum creatinine (mg/dL)

Females:

Creatinine clearance (mL/min) = Weight (kg) × (140 Age) × 0.85 72 × serum creatinine (mg/dL)

11 Body weight >30 kg at enrolment and first IP dose administration. 12 Male or female. 13 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:

  1. 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).
  2. 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).

Exclusion criteria:

  1. Patients with locally-advanced NSCLC whose disease has progressed following platinum based sCRT.
  2. Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumours.
  3. Mixed small-cell lung cancer and NSCLC histology.
  4. History of allogeneic organ transplantation.
  5. 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, uveitis, etc]). The following are exceptions to this criterion:

    1. Patients with vitiligo or alopecia.
    2. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
    3. Any chronic skin condition that does not require systemic therapy.
    4. Patients without active disease in the last 5 years at enrolment may be included but only after consultation with the Study Physician.
    5. Patients with celiac disease controlled by diet alone.
  6. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, 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.
  7. History of another primary malignancy except for:

    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    3. Adequately treated carcinoma in situ without evidence of disease.
  8. History of leptomeningeal carcinomatosis.
  9. History of active primary immunodeficiency.
  10. 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 hepatitis B surface antigen [HbsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
  11. Any unresolved toxicity of NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

    1. Patients with Grade ≥2 neuropathy or Grade ≥2 lymphopenia will be evaluated on a case-by-case basis after consultation with the Study Physician.
    2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab (MEDI4736) may be included only after consultation with the Study Physician.
  12. Known allergy or hypersensitivity to durvalumab (MEDI4736) or any of the IP excipients.
  13. Patients who have received cCRT for locally-advanced NSCLC, or who received sCRT with at least 2 concomitant CRT cycles. Prior surgical resection (ie, Stage I or II) is permitted.

    Note: Patients whose platinum-based chemotherapy contained gemcitabine and who received sCRT with at least 1 concomitant CRT cycle are excluded from this study.

  14. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

    Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.

  15. 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.

  16. Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines.
  17. Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:

    1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection);
    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;
    3. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  18. Previous IP assignment in the present study.
  19. Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
  20. Participation in another clinical study with an IP during the 4 weeks prior to the first IP dose administration.
  21. Prior randomisation or treatment in a previous durvalumab (MEDI4736) ± tremelimumab clinical study regardless of treatment arm assignment.
  22. 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 IP.
  23. Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
  24. Genetic research study (optional):

Exclusion criteria for participation in the optional (DNA) genetic research component of the study include:

  1. Previous allogeneic bone marrow transplant.
  2. Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693300


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Georgia
Research Site Completed
Gainesville, Georgia, United States, 30501
United States, Tennessee
Research Site Recruiting
Knoxville, Tennessee, United States, 37920
France
Research Site Recruiting
Creteil, France, 94010
Research Site Recruiting
Paris Cedex 05, France, 75248
Research Site Terminated
Saint Priest en Jarez, France, 42270
Research Site Recruiting
Toulouse Cedex 9, France, 31400
Germany
Research Site Recruiting
Gauting, Germany, 82131
Research Site Recruiting
Großhansdorf, Germany, 22927
Research Site Terminated
Hamm, Germany, 59063
Research Site Recruiting
Hannover, Germany, 30459
Research Site Recruiting
Heidelberg, Germany, 69126
Italy
Research Site Recruiting
Avellino, Italy, 83100
Research Site Recruiting
Meldola, Italy, 47014
Research Site Recruiting
Milano, Italy, 20133
Research Site Recruiting
Milano, Italy, 20141
Research Site Recruiting
Monza, Italy, 20900
Research Site Recruiting
Parma, Italy, 43126
Research Site Recruiting
Roma, Italy, 00152
Spain
Research Site Recruiting
Barcelona, Spain, 08907
Research Site Recruiting
Guadalajara, Spain, 19002
Research Site Recruiting
Madrid, Spain, 28041
Research Site Recruiting
Sevilla, Spain, 41013
Research Site Recruiting
Valencia, Spain, 46015
United Kingdom
Research Site Recruiting
Leeds, United Kingdom, LS9 7TF
Research Site Recruiting
Manchester, United Kingdom, M20 4BX
Research Site Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Research Site Recruiting
Nottingham, United Kingdom, NG5 1PB
Research Site Recruiting
Sheffield, United Kingdom, S10 2SJ
Research Site Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03693300    
Other Study ID Numbers: D4194C00006
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Stage III Non-Small Cell Lung Cancer
Durvalumab
IV infusion immunoglobulin G (IgG)
Antibody-dependent cellular cytotoxicity
Complement-dependent cytotoxicity
Monotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents