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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004336-31 | EudraCT Number |
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This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60 Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or hypofractionated BED]). Patients must not have progressed following radiation therapy, and radiation therapy must be completed within 6 weeks (42 days) prior to first study drug administration. The last dose of radiation therapy is defined as the day of the last radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Patients received standard radiotherapy [60 gray (Gy) ± 10% or hypofractionated BED] prior to study entry. |
|
| Cohort B | Experimental | Patients received palliative radiotherapy [40 to < 54 Gy or hypofractionated BED] prior to study entry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE. | From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival (mPFS) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. |
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Inclusion Criteria:
Capable of giving signed informed consent.
Age ≥ 18 years at study entry.
Histologically or cytologically documented NSCLC with locally-advanced, unresectable Stage III disease.
Deemed ineligible for chemotherapy per Investigator assessment.
Receipt of radiation therapy that was completed within 42 days prior to first study drug administration.
Must have received a total dose of radiation of 40 to 66 Gy (standard or hypofractionated BED).
Must not have progressed following radiation therapy, as per Investigator assessed RECIST 1.1 criteria: a) Patients with measurable disease and/or nonmeasurable and/or no evidence of disease assessed at baseline by computed tomography /magnetic resonance imaging will be eligible for this study. b) Prior irradiated lesions may be considered measurable and selected as target lesions (TLs) providing they fulfill the other criteria for measurability.
World Health Organization/ECOG performance status of ≤2.
No prior exposure to immune-mediated therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and antiprogrammed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Patients must have adequate organ and marrow function as defined below:
Life expectancy of greater than 12 weeks.
Body weight greater than 30 kg at study entry and at first study drug administration
Exclusion Criteria:
Exclusion criteria for participation in the optional genetics research component of the study include: a) Previous allogeneic bone marrow transplant b)Nonleukocyte-depleted whole blood transfusion within 120 days of genetic sample collection.
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| Name | Affiliation | Role |
|---|---|---|
| Dr Andrea Riccardo Filippi | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85704 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34775804 | Derived | Filippi AR, Dziadziuszko R, Garcia Campelo MR, Paoli JB, Sawyer W, Diaz Perez IE. DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. Future Oncol. 2021 Dec;17(34):4657-4663. doi: 10.2217/fon-2021-0952. Epub 2021 Nov 15. |
| Label | URL |
|---|---|
| CSP Redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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.
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.
Eligible patients who met all inclusion criteria were enrolled in the study. However, one patient was later found to have an important protocol deviation, and many other patients had protocol deviations. Study assessments followed scheduled timeline. Enrolled patients had Stage III unresectable Non-Small Cell Lung Cancer (NSCLC), an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2, had been treated with radiotherapy, and were ineligible for chemotherapy.
Patients were enrolled and received study treatment at 29 sites in 5 countries (France, Italy, Poland, Russian Federation, and Spain). The data in this report are based on study start date (first patient enrolled: 26 November 2020 till final analyses data cut-off date of 06 December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab Cohort A: Standard Radiotherapy (RT) | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2023 | Dec 17, 2024 |
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| From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months) |
| Progression-free Survival at 6 Months (PFS6) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. | From the first date of treatment until the date of objective disease progression or death (6 months) |
| Progression-free Survival at 12 Months (PFS12) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. | From the first date of treatment until the date of objective disease progression or death (12 months) |
| Median Overall Survival (mOS) | The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. | From the first date of treatment until death or data cut-off due to any cause (36 months) |
| Overall Survival at 12 Months (OS12) | The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. | From the first date of treatment until death due to any cause (12 months) |
| Objective Response Rate (ORR) | The ORR is the proportion (%) of patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria. CR is disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months) |
| Duration of Response (DoR) | The DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. | From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months) |
| Lung Cancer Mortality | The lung cancer mortality (NSCLC-related death) is assessed using the deaths which are reported as 'NSCLC-related' and is defined as the time (days) from the date of first dose of durvalumab until date of death due to lung cancer. | From date of treatment start until death due to lung cancer (36 months) |
| Number of Patients With Events (AEs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. | From screening (Day -28) till data cut-off (36 months) |
| Number of Patients With Adverse Events of Special Interests (AESIs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An AESI is an AE of scientific and medical interest specific to the understanding of durvalumab. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Here, number of patients experienced AESIs are presented. Serious adverse event of special interests (SAESIs). | From screening (Day -28) till data cut-off (36 months) |
| Number of Patients With Immune-mediated Adverse Events (imAEs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate etiology. Here, number of patients experienced imAEs are presented. Immune-mediated serious adverse events (imSAEs) | From screening (Day -28) till data cut-off (36 months) |
| Tampa |
| Florida |
| 33612 |
| United States |
| Research Site | Royal Oak | Michigan | 48073 | United States |
| Research Site | Limoges | 87000 | France |
| Research Site | Marseille | 13009 | France |
| Research Site | Montpellier | 34070 | France |
| Research Site | Nîmes | 30029 | France |
| Research Site | Rouen | 76031 | France |
| Research Site | Brescia | 25100 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Meldola | 47014 | Italy |
| Research Site | Messina | 98158 | Italy |
| Research Site | Modena | 41124 | Italy |
| Research Site | Monza | 20900 | Italy |
| Research Site | Negrar | 37024 | Italy |
| Research Site | Pavia | 27100 | Italy |
| Research Site | Pisa | 56124 | Italy |
| Research Site | Ravenna | 48121 | Italy |
| Research Site | Roma | 00128 | Italy |
| Research Site | Bialystok | 15-044 | Poland |
| Research Site | Gdansk | 80-214 | Poland |
| Research Site | Olsztyn | 10-228 | Poland |
| Research Site | Szczecin | 71-730 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Saint Petersburg | 197002 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Ufa | 450054 | Russia |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Castellon | 12002 | Spain |
| Research Site | Madrid | 28050 | Spain |
| Research Site | Oviedo | 33011 | Spain |
| Research Site | Pamplona | 31008 | Spain |
| Research Site | Sabadell(Barcelona) | 08208 | Spain |
| SAP Redacted | View source |
| CSR synopsis Redacted | View source |
| FG001 | Durvaumab Cohort B: Palliative Radiotherapy (RT) | Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| COMPLETED |
|
| NOT COMPLETED |
|
The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab Cohort A: Standard Radiotherapy (RT) | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG001 | Durvaumab Cohort B: Palliative Radiotherapy (RT) | Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | The safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment. A PRAE was any TEAE with a possible relatedness to durvalumab, or where the relatedness was missing. If relatedness of a TEAE was missing at the primary DCO (30 March 2023) the TEAE was considered a PRAE. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Count of Participants | Participants | From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (mPFS) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Median | 95% Confidence Interval | Months | From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival at 6 Months (PFS6) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | From the first date of treatment until the date of objective disease progression or death (6 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival at 12 Months (PFS12) | Progression-free survival is defined as the time from the date of first dose of durvalumab until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient discontinues durvalumab or receives another anticancer therapy prior to progression according to RECIST 1.1 as assessed by the Investigator. Patients who had not progressed or died at the time of analysis were censored at the date of their last evaluable tumor assessment. If a patient progressed or died after two or more missed visits, they were censored at the date of the latest evaluable assessment prior to the missed visits. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | From the first date of treatment until the date of objective disease progression or death (12 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (mOS) | The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Median | 95% Confidence Interval | Months | From the first date of treatment until death or data cut-off due to any cause (36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival at 12 Months (OS12) | The OS is defined as the time from the date of first dose of durvalumab until death due to any cause. Patients who were not known to have died at the time of analysis were censored at the last recorded date when they were known to have been alive. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | From the first date of treatment until death due to any cause (12 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | The ORR is the proportion (%) of patients with an overall response of complete response (CR) or partial response (PR) (confirmed by a follow-up scan at least 4 weeks after showing CR or PR) per RECIST 1.1 criteria. CR is disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to < 10 mm. PR is at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Number | 95% Confidence Interval | Percentage of patients | From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | The DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until the first date of documented progression per RECIST1.1 or death in the absence of disease progression. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. Number of participants analyzed and number analyzed here represents number of patients with objective response. | Posted | Median | 95% Confidence Interval | Weeks | From 8 weeks ±1 week after durvalumab treatment initiation and continue every 8 weeks (q8w) ±1 week through 48 weeks and every 12 weeks (q12w) ±1 week until disease progression or data cut-off (36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Lung Cancer Mortality | The lung cancer mortality (NSCLC-related death) is assessed using the deaths which are reported as 'NSCLC-related' and is defined as the time (days) from the date of first dose of durvalumab until date of death due to lung cancer. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Median | 95% Confidence Interval | Months | From date of treatment start until death due to lung cancer (36 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Events (AEs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Count of Participants | Participants | From screening (Day -28) till data cut-off (36 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events of Special Interests (AESIs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An AESI is an AE of scientific and medical interest specific to the understanding of durvalumab. AESIs for durvalumab include, but are not limited to, events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy. Here, number of patients experienced AESIs are presented. Serious adverse event of special interests (SAESIs). | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Count of Participants | Participants | From screening (Day -28) till data cut-off (36 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Immune-mediated Adverse Events (imAEs) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. An imAE is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate etiology. Here, number of patients experienced imAEs are presented. Immune-mediated serious adverse events (imSAEs) | The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment. | Posted | Count of Participants | Participants | From screening (Day -28) till data cut-off (36 months) |
|
From screening (Day -28) till data cut-off (36 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Durvalumab Cohort A: Standard Radiotherapy (RT) | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated bioequivalent dose (BED)] before study entry were administered a fixed dose of 1500 mg of durvalumab via intravenous (IV) infusion every 4 weeks (q4w) for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the response evaluation criteria in solid tumors version (RECIST 1.1), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 23 | 53 | 23 | 53 | 47 | 53 |
| EG001 | Durvaumab Cohort B: Palliative Radiotherapy (RT) | Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 23 | 49 | 18 | 49 | 45 | 49 |
| EG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. | 46 | 102 | 41 | 102 | 92 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Enterobacter sepsis | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 26.1 | Non-systematic Assessment |
|
This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2024 | Dec 17, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Male |
|
| Other |
|
| Unknown |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Missing |
|
| Durvaumab Cohort B: Palliative Radiotherapy (RT) |
Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| Durvaumab Cohort B: Palliative Radiotherapy (RT) |
Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| Durvaumab Cohort B: Palliative Radiotherapy (RT) |
Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
Patients who received palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|
| OG002 | Durvalumab Total | Patients who received standard RT [60 gray (GY) ± 10% or hypofractionated BED)] or palliative RT [40 to < 54 Gy or hypofractionated BED] before study entry were administered a fixed dose of 1500 mg of durvalumab via IV infusion q4w for a duration of 12 months (up to 13 doses/cycles), or until clinical progression or radiological progression defined by the RECIST 1.1, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. |
|
|