Non-small Cell Lung Cancer
Conditions
Keywords
Radiation therapy, Phase II, Palliative Radiotherapy
Brief summary
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 \[40 to \< 54 Gy or hypofractionated BED\])
Detailed description
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)
Interventions
DRUGDurvalumab
All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
1. Capable of giving signed informed consent. 2. Age ≥ 18 years at study entry. 3. Histologically or cytologically documented NSCLC with locally-advanced, unresectable Stage III disease. 4. Deemed ineligible for chemotherapy per Investigator assessment. 5. Receipt of radiation therapy that was completed within 42 days prior to first study drug administration. 6. Must have received a total dose of radiation of 40 to 66 Gy (standard or hypofractionated BED). 7. 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. 8. World Health Organization/ECOG performance status of ≤2. 9. 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. 10. Patients must have adequate organ and marrow function as defined below: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1.0 × 109 /L * Platelet count ≥ 75 × 109/L * Serum bilirubin ≤ 1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome. * Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN * Measured creatinine clearance \> 30 mL/min or calculated CL \> 30 mL/min as determined by Cockcroft-Gault 11. Life expectancy of greater than 12 weeks. 12. Body weight greater than 30 kg at study entry and at first study drug administration
Exclusion criteria
1. Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy. 2. Mixed small cell lung cancer and NSCLC histology. 3. History of allogeneic organ transplantation. 4. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome). 5. Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris) 6. History of another primary malignancy except for (a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first study drug administration, (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, and c) treated carcinoma in situ without evidence of disease. 7. History of leptomeningeal carcinomatosis 8. History of active primary immunodeficiency 9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus 10. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criteria 11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 12. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab 13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab. 14. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. 15. Participation in another clinical study with an IP administered in the last 4 weeks. 16. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study 17. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment 18. Patients who refuse chemotherapy by their own decision. 19. Involvement in the planning and/or conduct of the study 20. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control. 21. Judgment by the Investigator that the patient should not participate in the study 22. Genetics research study (optional):
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival at 6 Months (PFS6) | From the first date of treatment until the date of objective disease progression or death (6 months) | 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. |
| Progression-free Survival at 12 Months (PFS12) | From the first date of treatment until the date of objective disease progression or death (12 months) | 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. |
| Median Overall Survival (mOS) | From the first date of treatment until death or data cut-off due to any cause (36 months) | 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. |
| Overall Survival at 12 Months (OS12) | From the first date of treatment until death due to any cause (12 months) | 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. |
| Objective Response Rate (ORR) | 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) | 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. |
| Median Progression-free Survival (mPFS) | 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 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. |
| Lung Cancer Mortality | From date of treatment start until death due to lung cancer (36 months) | 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. |
| Number of Patients With Events (AEs) | From screening (Day -28) till data cut-off (36 months) | The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed. |
| Number of Patients With Adverse Events of Special Interests (AESIs) | From screening (Day -28) till data cut-off (36 months) | 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). |
| Number of Patients With Immune-mediated Adverse Events (imAEs) | From screening (Day -28) till data cut-off (36 months) | 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) |
| Duration of Response (DoR) | 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) | 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. |
Countries
France, Italy, Poland, Russia, Spain, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 49 |
| Total | 102 |
Baseline characteristics
| Characteristic | Total | Durvaumab Cohort B: Palliative Radiotherapy (RT) | Durvalumab Cohort A: Standard Radiotherapy (RT) |
|---|---|---|---|
| Age, Continuous | 76.7 Years STANDARD_DEVIATION 8.32 | 78.8 Years STANDARD_DEVIATION 6.71 | 74.7 Years STANDARD_DEVIATION 9.18 |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Missing | 9 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 88 Participants | 43 Participants | 45 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 91 Participants | 45 Participants | 46 Participants |
| Sex: Female, Male Female | 29 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Male | 73 Participants | 35 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 53 | 23 / 49 | 46 / 102 |
| other Total, other adverse events | 47 / 53 | 45 / 49 | 92 / 102 |
| serious Total, serious adverse events | 23 / 53 | 18 / 49 | 41 / 102 |
Outcome results
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.
Time frame: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | 5 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | 5 Participants |
| Durvalumab Total | Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) | 10 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Duration of Response (DoR) | 56.9 Weeks |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Duration of Response (DoR) | 34.1 Weeks |
| Durvalumab Total | Duration of Response (DoR) | 56.9 Weeks |
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.
Time frame: From date of treatment start until death due to lung cancer (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Lung Cancer Mortality | 30.9 Months |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Lung Cancer Mortality | NA Months |
| Durvalumab Total | Lung Cancer Mortality | 30.9 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.
Time frame: From the first date of treatment until death or data cut-off due to any cause (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Median Overall Survival (mOS) | 21.1 Months |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Median Overall Survival (mOS) | 16.8 Months |
| Durvalumab Total | Median Overall Survival (mOS) | 21.1 Months |
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.
Time frame: From the first date of treatment until the date of objective disease progression or death or data cut-off date (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Median Progression-free Survival (mPFS) | 10.3 Months |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Median Progression-free Survival (mPFS) | 7.6 Months |
| Durvalumab Total | Median Progression-free Survival (mPFS) | 9.2 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).
Time frame: From screening (Day -28) till data cut-off (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome resolved | 13 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received systemic corticosteroids | 5 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs, causally related to treatment | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received other immunosuppressants | 0 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received high dose steroids | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received endocrine therapy | 6 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs, causally related to treatment | 19 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs [including events with outcome = death]) | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs | 25 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of CTCAE Grade 3 or 4, causally related to treatment | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs leading to discontinuation of durvalumab treatment | 4 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome not resolved | 11 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death, causally related to treatment | 1 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death | 1 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs [including events with outcome = death]) | 1 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs, causally related to treatment | 14 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs, causally related to treatment | 1 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death, causally related to treatment | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received systemic corticosteroids | 8 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received high dose steroids | 6 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received other immunosuppressants | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs leading to discontinuation of durvalumab treatment | 3 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome resolved | 12 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome not resolved | 9 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs | 21 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 1 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of CTCAE Grade 3 or 4, causally related to treatment | 1 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received endocrine therapy | 5 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 5 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome resolved | 25 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs, causally related to treatment | 5 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any SAESIs [including events with outcome = death]) | 5 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Event outcome not resolved | 20 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs, causally related to treatment | 33 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs of CTCAE Grade 3 or 4, causally related to treatment | 5 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received high dose steroids | 10 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received endocrine therapy | 11 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received systemic corticosteroids | 13 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death | 1 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | AESIs: Received other immunosuppressants | 0 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs | 46 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs leading to discontinuation of durvalumab treatment | 7 Participants |
| Durvalumab Total | Number of Patients With Adverse Events of Special Interests (AESIs) | Any AESIs with outcome = death, causally related to treatment | 1 Participants |
Secondary
Number of Patients With Events (AEs)
The safety and tolerability profile of durvalumab treatment, including all adverse events (AEs) was assessed.
Time frame: From screening (Day -28) till data cut-off (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4, possibly related to durvalumab treatment (IA) | 6 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death), possibly related to treatment (IA) | 19 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE | 50 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any PRAE (Investigator-assessed [IA]) | 31 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4 | 20 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE with outcome of death | 5 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE with outcome of death, possibly related to treatment (IA) | 1 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death) | 23 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death), possibly related to treatment (IA) | 5 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment | 13 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment, possibly related to treatment (IA) | 7 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to treatment interruption | 25 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to treatment interruption, possibly related to treatment | 6 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death) (IA) | 25 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any Adverse event of potential interest (AEPI) (including events with outcome of death) (IA) | 21 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AEPI (including events with outcome of death), possibly related to treatment (IA) | 14 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any imAE (IA) | 27 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Events (AEs) | Any imAE, possibly related to treatment (IA) | 26 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any imAE, possibly related to treatment (IA) | 24 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to treatment interruption, possibly related to treatment | 7 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death), possibly related to treatment (IA) | 14 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment | 9 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE | 49 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any Adverse event of potential interest (AEPI) (including events with outcome of death) (IA) | 22 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any imAE (IA) | 24 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any PRAE (Investigator-assessed [IA]) | 31 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AEPI (including events with outcome of death), possibly related to treatment (IA) | 15 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death) (IA) | 21 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4 | 21 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment, possibly related to treatment (IA) | 5 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death), possibly related to treatment (IA) | 3 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4, possibly related to durvalumab treatment (IA) | 5 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death) | 18 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE leading to treatment interruption | 23 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE with outcome of death | 2 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Events (AEs) | Any AE with outcome of death, possibly related to treatment (IA) | 0 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE with outcome of death | 7 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE with outcome of death, possibly related to treatment (IA) | 1 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death) | 41 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any Adverse event of potential interest (AEPI) (including events with outcome of death) (IA) | 43 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any SAE (including events with outcome of death), possibly related to treatment (IA) | 8 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any imAE, possibly related to treatment (IA) | 50 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment | 22 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE leading to discontinuation of treatment, possibly related to treatment (IA) | 12 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AEPI (including events with outcome of death), possibly related to treatment (IA) | 29 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE leading to treatment interruption | 48 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE leading to treatment interruption, possibly related to treatment | 13 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE | 99 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any PRAE (Investigator-assessed [IA]) | 62 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4 | 41 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death) (IA) | 46 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AE of CTCAE Grade 3 or Grade 4, possibly related to durvalumab treatment (IA) | 11 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any AESI (including events with outcome of death), possibly related to treatment (IA) | 33 Participants |
| Durvalumab Total | Number of Patients With Events (AEs) | Any imAE (IA) | 51 Participants |
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)
Time frame: From screening (Day -28) till data cut-off (36 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs | 11 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 2 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs, causally related to treatment | 10 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs, causally related to treatment | 3 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received systemic corticosteroids | 7 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received endocrine therapy | 6 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received other immunosuppressants | 0 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs leading to discontinuation of durvalumab treatment | 3 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome not resolved | 5 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs [including events with outcome = death]) | 3 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death | 1 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of CTCAE Grade 3 or 4, causally related to treatment | 2 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death, causally related to treatment | 1 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received high dose steroids | 5 Participants |
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome resolved | 5 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome resolved | 8 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome not resolved | 7 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 3 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death, causally related to treatment | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs | 15 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs, causally related to treatment | 12 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs leading to discontinuation of durvalumab treatment | 4 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received other immunosuppressants | 0 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of CTCAE Grade 3 or 4, causally related to treatment | 3 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs, causally related to treatment | 2 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received high dose steroids | 7 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs [including events with outcome = death]) | 2 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received systemic corticosteroids | 13 Participants |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received endocrine therapy | 5 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome resolved | 13 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received endocrine therapy | 11 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received systemic corticosteroids | 20 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs leading to discontinuation of durvalumab treatment | 7 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Event outcome not resolved | 12 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs | 26 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 | 5 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs [including events with outcome = death]) | 5 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received high dose steroids | 12 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death | 1 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | imAEs: Received other immunosuppressants | 0 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs, causally related to treatment | 22 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs of CTCAE Grade 3 or 4, causally related to treatment | 5 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imAEs with outcome = death, causally related to treatment | 1 Participants |
| Durvalumab Total | Number of Patients With Immune-mediated Adverse Events (imAEs) | Any imSAEs, causally related to treatment | 5 Participants |
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.
Time frame: 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)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Objective Response Rate (ORR) | 34.0 Percentage of patients |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Objective Response Rate (ORR) | 24.5 Percentage of patients |
| Durvalumab Total | Objective Response Rate (ORR) | 29.4 Percentage of patients |
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.
Time frame: From the first date of treatment until death due to any cause (12 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Overall Survival at 12 Months (OS12) | 64.0 Percentage of patients |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Overall Survival at 12 Months (OS12) | 65.5 Percentage of patients |
| Durvalumab Total | Overall Survival at 12 Months (OS12) | 64.7 Percentage of patients |
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.
Time frame: From the first date of treatment until the date of objective disease progression or death (12 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Progression-free Survival at 12 Months (PFS12) | 46.8 Percentage of patients |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Progression-free Survival at 12 Months (PFS12) | 31.8 Percentage of patients |
| Durvalumab Total | Progression-free Survival at 12 Months (PFS12) | 39.6 Percentage of patients |
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.
Time frame: From the first date of treatment until the date of objective disease progression or death (6 months)
Population: The safety analysis set consisted of all patients who received at least one dose of durvalumab treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Durvalumab Cohort A: Standard Radiotherapy (RT) | Progression-free Survival at 6 Months (PFS6) | 67.1 Percentage of patients |
| Durvaumab Cohort B: Palliative Radiotherapy (RT) | Progression-free Survival at 6 Months (PFS6) | 59.3 Percentage of patients |
| Durvalumab Total | Progression-free Survival at 6 Months (PFS6) | 63.3 Percentage of patients |