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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000867-10 | EudraCT Number |
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This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab + Placebo | Experimental | Durvalumab monotherapy: Durvalumab (1500 mg intravenous [IV]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution. |
|
| Durvalumab + Tremelimumab | Experimental | Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab. |
|
| Placebo + Placebo | Placebo Comparator | Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab IV (intravenous infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
| Durvalumab Versus Placebo: Overall Survival (OS) | OS was defined as the time from the date of randomization until death due to any cause. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Progression-Free Survival Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. |
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Inclusion criteria:
4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyi Jiang, M.D. | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85715 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41921748 | Derived | Senan S, Cho BC, Laktionov KK, Zenke Y, Lee KH, Wang Q, Navarro A, Buchmeier EL, Goksu SS, Badzio A, Shi A, Daniel DB, Zemanova M, Iyengar P, Paz-Ares L, Szadkowski L, Chugh P, Lai WV, Spigel DR. Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic Cranial Irradiation in the Phase 3 ADRIATIC Trial. J Thorac Oncol. 2026 Mar 30:103703. doi: 10.1016/j.jtho.2026.103703. Online ahead of print. | |
| 40976711 |
| Label | URL |
|---|---|
| d933qc00001-csp-v5\_for redaction\_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.
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 refer 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.
Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded independent data monitoring committee [IDMC]), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
This Phase III, double-blind, placebo-controlled trial studied participants with limited stage small-cell lung cancer who had not progressed after concurrent chemoradiation therapy at 164 sites in 19 countries. Interim results are based on data cut-off (DCO) date of 15 January 2024. 730 participants were randomized; the first 600 in a 1:1:1 ratio to durvalumab monotherapy (D), durvalumab plus tremelimumab combination therapy (D+T) or placebo (P), the remaining in a 1:1 ratio to D or P.
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| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab | Participants received durvalumab monotherapy (1500 milligram [mg] for participants >30 kilogram [kg] in weight and a weight-based dosing equivalent to 20 mg/kg for participants <=30 kg in weight) via intravenous (IV) infusion once every 4 weeks (q4w), until clinical/Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| 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 | Jan 10, 2023 | Jul 31, 2025 |
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| Tremelimumab | Drug | Tremelimumab IV (intravenous infusion) |
|
| Placebo | Other | Placebo IV (intravenous infusion) |
|
| Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Overall Survival | OS is defined as the time from the date of randomization until death due to any cause. | From date of randomization until death due to any cause, up to approximately 89 months |
| Durvalumab Versus Placebo: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) (i.e., unconfirmed response). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Objective Response Rate Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | From date of randomization until death due to any cause, up to approximately 89 months |
| Durvalumab Versus Placebo: Percentage of Participants Progression-Free at 18 Months Following Randomization (PFS18) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS18 was defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 18 months following randomization. | Month 18 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Progression-Free at 18 Months Following Randomization Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS18 is defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 18 months following randomization. | Month 18 |
| Durvalumab Versus Placebo: Percentage of Participants Progression-Free at 24 Months Following Randomization (PFS24) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS24 was defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 24 months following randomization. | Month 24 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Progression-Free at 24 Months Following Randomization Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS24 is defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 24 months following randomization. | Month 24 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Time to Death or Distant Metastasis (TTDM) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | TTDM per RECIST 1.1 is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the radiation field according to RECIST 1.1 or proven by biopsy. | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months |
| Durvalumab Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization (OS24) | OS was defined as the time from the date of randomization until death due to any cause. The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months after randomization. | Month 24 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization | OS is defined as the time from the date of randomization until death due to any cause. The OS24 is defined as the Kaplan-Meier estimate of OS at 24 months after randomization. | Month 24 |
| Durvalumab Versus Placebo: Percentage of Participants Alive at 36 Months From Randomization (OS36) | OS was defined as the time from the date of randomization until death due to any cause. The OS36 was defined as the Kaplan-Meier estimate of OS at 36 months after randomization. | Month 36 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Alive at 36 Months From Randomization | OS is defined as the time from the date of randomization until death due to any cause. The OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after randomization. | Month 36 |
| Durvalumab Plus Tremelimumab Combination Versus Placebo: Time From Randomization to Second Progression (PFS2) | PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to the first subsequent anticancer therapy (excluding radiotherapy) or death. The date of second progression is recorded by the Investigator in the eCRF at each assessment and defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months |
| Durvalumab Versus Durvalumab Plus Tremelimumab: Progression-Free Survival Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months |
| Durvalumab Versus Durvalumab Plus Tremelimumab: Objective Response Rate Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | From date of randomization until death due to any cause, up to approximately 89 months |
| Durvalumab Versus Durvalumab Plus Tremelimumab: Overall Survival | OS is defined as the time from the date of randomization until death due to any cause. | From date of randomization until death due to any cause, up to approximately 89 months |
| Durvalumab Plus Tremelimumab Versus Placebo: Change From Baseline in Patient-Reported Symptoms as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) | Patient-reported outcomes for 5 disease related symptoms will be assessed using EORTC QLQ-Core 30 (C30) items questionnaire (fatigue, appetite loss) and EORTC QLQ-Lung Cancer module 13 (LC13) (dyspnea, cough and pain in chest). An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales/symptom items, functional scales, and global health status (GHS) scale with higher scores on GHS/QoL and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. | Baseline (Day 1) and up to approximately 89 months |
| Durvalumab: Serum Concentration of Durvalumab | Blood samples were collected to determine the concentration of durvalumab. | End of infusion on Cycle 1 Day 1, pre-infusion on Cycle 2 (Week 4), Cycle 5 (Week 16) and Cycle 26 (Week 100) and Month 3 post last dose of study treatment (Week 119) (each treatment cycle is 28 days) |
| Durvalumab Plus Tremelimumab: Serum Concentration of Tremelimumab | Blood samples will be collected to determine the concentration of tremelimumab. | Up to approximately 27 months |
| Durvalumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab | Blood samples were collected to determine the presence of ADAs for durvalumab using validated assays. Treatment-emergent ADA-positive was defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Number of participants with treatment-emergent ADA (ADA incidence) are presented. | From first dose of study drug (Day 1) up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
| Durvalumab Plus Tremelimumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab | Blood samples will be collected to determine the presence of ADAs for tremelimumab using validated assays. Treatment-emergent ADA-positive is defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-boosted ADA is defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Treatment-induced ADA is defined as ADA positive post-baseline and not detected at baseline. | Up to approximately 30 months |
| Durvalumab Versus Durvalumab Plus Tremelimumab: Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Status Based on Progression-Free Survival, Overall Survival, and Objective Response Rate | Blood samples will be collected for clinical biomarker testing and a tumor specimen will be collected as per tumor specimen collection requirements. The specimen will be evaluated by immunohistochemistry to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and will be assessed using the VENTANA PD-L1 (SP263) assay. | Up to approximately 89 months |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Research Site | New Haven | Connecticut | 06510 | United States |
| Research Site | Fort Myers | Florida | 33901 | United States |
| Research Site | Orange City | Florida | 32763 | United States |
| Research Site | St. Petersburg | Florida | 33705 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Hines | Illinois | 60141 | United States |
| Research Site | Fort Wayne | Indiana | 46804 | United States |
| Research Site | Muncie | Indiana | 47303 | United States |
| Research Site | Lexington | Kentucky | 40536 | United States |
| Research Site | Annapolis | Maryland | 21401 | United States |
| Research Site | Baltimore | Maryland | 21287 | United States |
| Research Site | Towson | Maryland | 21204 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Detroit | Michigan | 48201 | United States |
| Research Site | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Minneapolis | Minnesota | 55407 | United States |
| Research Site | Summit | New Jersey | 07902 | United States |
| Research Site | New Hyde Park | New York | 11042 | United States |
| Research Site | Chapel Hill | North Carolina | 27599 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | Philadelphia | Pennsylvania | 19111 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Sioux Falls | South Dakota | 57104 | United States |
| Research Site | Chattanooga | Tennessee | 37404 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Kennewick | Washington | 99336 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Charleston | West Virginia | 25304 | United States |
| Research Site | Huntington | West Virginia | 25701 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | CABA | C1012AAR | Argentina |
| Research Site | Ciudad de Buenos Aires | C1280AEB | Argentina |
| Research Site | Córdoba | X5004BAL | Argentina |
| Research Site | Mar del Plata | 7600 | Argentina |
| Research Site | Rosario | 2000 | Argentina |
| Research Site | Aalst | 9300 | Belgium |
| Research Site | Anderlecht | 1070 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Hasselt | 3500 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Toronto | CA | M5G 2M9 | Canada |
| Research Site | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Research Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Research Site | London | Ontario | N6A 5W9 | Canada |
| Research Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Beijing | 100021 | China |
| Research Site | Beijing | 100036 | China |
| Research Site | Beijing | 100142 | China |
| Research Site | Beijing | 100191 | China |
| Research Site | Beijing | 100730 | China |
| Research Site | Bengbu | 233004 | China |
| Research Site | Changchun | 130000 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Chengdu | 610042 | China |
| Research Site | Chongqing | 400030 | China |
| Research Site | Chongqing | 400042 | China |
| Research Site | Fuzhou | 350011 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hefei | 230601 | China |
| Research Site | Shanghai | 200030 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shenyang | 110001 | China |
| Research Site | Shenyang | 110042 | China |
| Research Site | Tianjin | 300060 | China |
| Research Site | Wuhan | 430010 | China |
| Research Site | Wuhan | 430022 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Zhengzhou | 450008 | China |
| Research Site | Brno | 639 00 | Czechia |
| Research Site | Olomouc | 77900 | Czechia |
| Research Site | Ostrava | 703 00 | Czechia |
| Research Site | Prague | 128 08 | Czechia |
| Research Site | Prague | 140 59 | Czechia |
| Research Site | Berlin | 12351 | Germany |
| Research Site | Cologne | 51109 | Germany |
| Research Site | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Gauting | 82131 | Germany |
| Research Site | Heidelberg | 69126 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Oldenburg | 26121 | Germany |
| Research Site | Regensburg | 93053 | Germany |
| Research Site | Stuttgart | 70376 | Germany |
| Research Site | Würzburg | 97080 | Germany |
| Research Site | Bengaluru | 560076 | India |
| Research Site | Gurgaon | 122001 | India |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Orbassano | 10043 | Italy |
| Research Site | Parma | 43126 | Italy |
| Research Site | Roma | 00100 | Italy |
| Research Site | Rozzano | 20089 | Italy |
| Research Site | Terni | 05100 | Italy |
| Research Site | Bunkyō City | 160-0023 | Japan |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 812-8582 | Japan |
| Research Site | Iwakuni-shi | 740-8510 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Kurume-shi | 830-0011 | Japan |
| Research Site | Nagoya | 464-8681 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Niigata | 951-8566 | Japan |
| Research Site | Sakaishi | 591-8555 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Sendai | 980-0873 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Tokushima | 770-8503 | Japan |
| Research Site | Ube-shi | 755-0241 | Japan |
| Research Site | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Groningen | 9713 GZ | Netherlands |
| Research Site | Harderwijk | 3844 DG | Netherlands |
| Research Site | Hengelo | 7555 DL | Netherlands |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Olsztyn | 10-357 | Poland |
| Research Site | Poznan | 60-569 | Poland |
| Research Site | Tomaszów Mazowiecki | 97-200 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Wroclaw | 53-413 | Poland |
| Research Site | Kazan' | 420029 | Russia |
| Research Site | Kirov | 610021 | Russia |
| Research Site | Moscow | 105229 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Moscow | 125284 | Russia |
| Research Site | Obninsk | 249036 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | Ufa | 450054 | Russia |
| Research Site | Volgograd | 400138 | Russia |
| Research Site | Changwon-si | 51353 | South Korea |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Goyang-si | 10408 | South Korea |
| Research Site | Jinju | 52727 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Oviedo | 33011 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Zaragoza | 50009 | Spain |
| Research Site | Hsinchu | 300 | Taiwan |
| Research Site | Kaohsiung City | 83301 | Taiwan |
| Research Site | Keelung | 20445 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Tainan | 736 | Taiwan |
| Research Site | Taipei | 112 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | Taoyuan City | 333 | Taiwan |
| Research Site | Yunlin | 640 | Taiwan |
| Research Site | Adana | 01060 | Turkey (Türkiye) |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Ankara | 06280 | Turkey (Türkiye) |
| Research Site | Antalya | 07059 | Turkey (Türkiye) |
| Research Site | Edirne | 22030 | Turkey (Türkiye) |
| Research Site | Istanbul | 34030 | Turkey (Türkiye) |
| Research Site | Izmir | 35620 | Turkey (Türkiye) |
| Research Site | Konya | 42080 | Turkey (Türkiye) |
| Research Site | Samsun | Turkey (Türkiye) |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Truro | TR1 3LJ | United Kingdom |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hà Nội | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Ho Chi Minh City | 70000 | Vietnam |
| Derived |
| Zenke Y, Shiraishi Y, Goto Y, Azuma K, Okishio K, Ogino H, Horio Y, Oizumi S, Hayama M, Nii M, Harada M, Mann H, Olivo YS, Jiang H, Senan S. Durvalumab Post Concurrent Chemoradiotherapy in Japanese Patients With Limited-Stage Small-Cell Lung Cancer in the Phase 3 ADRIATIC Trial. Cancer Sci. 2025 Nov;116(11):3171-3184. doi: 10.1111/cas.70188. Epub 2025 Sep 21. |
| 39268857 | Derived | Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Sezgin Goksu S, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327. doi: 10.1056/NEJMoa2404873. Epub 2024 Sep 13. |
| 31948903 | Derived | Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28. |
| d933qc00001-csp-v1-addendum-eu\_Redacted | View source |
| Redacted SAP | View source |
| Redacted CSR synopsis | View source |
| FG001 | Durvalumab Plus Tremelimumab | Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants >30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants <=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| FG002 | Placebo | Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab | Participants received durvalumab monotherapy (1500 mg for participants >30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants <=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| BG001 | Durvalumab Plus Tremelimumab | Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants >30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants <=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| BG002 | Placebo | Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
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| Primary | Durvalumab Versus Placebo: Overall Survival (OS) | OS was defined as the time from the date of randomization until death due to any cause. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Progression-Free Survival Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. | Not Posted | Mar 2027 | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Overall Survival | OS is defined as the time from the date of randomization until death due to any cause. | Not Posted | Mar 2027 | From date of randomization until death due to any cause, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Placebo: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) (i.e., unconfirmed response). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | The FAS included all randomized participants. Only participants with measurable disease at baseline per BICR are reported. | Posted | Number | percentage of participants | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Objective Response Rate Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | Not Posted | Mar 2027 | From date of randomization until death due to any cause, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Placebo: Percentage of Participants Progression-Free at 18 Months Following Randomization (PFS18) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS18 was defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 18 months following randomization. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 18 |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Progression-Free at 18 Months Following Randomization Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS18 is defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 18 months following randomization. | Not Posted | Mar 2027 | Month 18 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Placebo: Percentage of Participants Progression-Free at 24 Months Following Randomization (PFS24) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS24 was defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 24 months following randomization. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 24 |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Progression-Free at 24 Months Following Randomization Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this included the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. The PFS24 is defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by BICR at 24 months following randomization. | Not Posted | Mar 2027 | Month 24 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Time to Death or Distant Metastasis (TTDM) Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | TTDM per RECIST 1.1 is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the radiation field according to RECIST 1.1 or proven by biopsy. | Not Posted | Mar 2027 | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization (OS24) | OS was defined as the time from the date of randomization until death due to any cause. The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months after randomization. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 24 |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Alive at 24 Months From Randomization | OS is defined as the time from the date of randomization until death due to any cause. The OS24 is defined as the Kaplan-Meier estimate of OS at 24 months after randomization. | Not Posted | Mar 2027 | Month 24 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Placebo: Percentage of Participants Alive at 36 Months From Randomization (OS36) | OS was defined as the time from the date of randomization until death due to any cause. The OS36 was defined as the Kaplan-Meier estimate of OS at 36 months after randomization. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 36 |
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| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Percentage of Participants Alive at 36 Months From Randomization | OS is defined as the time from the date of randomization until death due to any cause. The OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after randomization. | Not Posted | Mar 2027 | Month 36 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Plus Tremelimumab Combination Versus Placebo: Time From Randomization to Second Progression (PFS2) | PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to the first subsequent anticancer therapy (excluding radiotherapy) or death. The date of second progression is recorded by the Investigator in the eCRF at each assessment and defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. | Not Posted | Mar 2027 | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Durvalumab Plus Tremelimumab: Progression-Free Survival Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS per RECIST 1.1 assessed by BICR is defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdraws from therapy or receives another anticancer therapy prior to progression. PD is defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir. | Not Posted | Mar 2027 | Response evaluations performed q8w ± 1 week up to 72 weeks, then q12w ± 1 week up to 96 weeks, and then q24w thereafter until PD, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Durvalumab Plus Tremelimumab: Objective Response Rate Assessed by Blinded Independent Central Review Per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR per RECIST 1.1 assessed by BICR is defined as the percentage of participants with at least 1 visit response of CR or PR (i.e., unconfirmed response). CR is defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | Not Posted | Mar 2027 | From date of randomization until death due to any cause, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Durvalumab Plus Tremelimumab: Overall Survival | OS is defined as the time from the date of randomization until death due to any cause. | Not Posted | Mar 2027 | From date of randomization until death due to any cause, up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Plus Tremelimumab Versus Placebo: Change From Baseline in Patient-Reported Symptoms as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) | Patient-reported outcomes for 5 disease related symptoms will be assessed using EORTC QLQ-Core 30 (C30) items questionnaire (fatigue, appetite loss) and EORTC QLQ-Lung Cancer module 13 (LC13) (dyspnea, cough and pain in chest). An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales/symptom items, functional scales, and global health status (GHS) scale with higher scores on GHS/QoL and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. | Not Posted | Mar 2027 | Baseline (Day 1) and up to approximately 89 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab: Serum Concentration of Durvalumab | Blood samples were collected to determine the concentration of durvalumab. | The pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug per the protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would have significantly affected the PK analyses. Only those participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | End of infusion on Cycle 1 Day 1, pre-infusion on Cycle 2 (Week 4), Cycle 5 (Week 16) and Cycle 26 (Week 100) and Month 3 post last dose of study treatment (Week 119) (each treatment cycle is 28 days) |
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| Secondary | Durvalumab Plus Tremelimumab: Serum Concentration of Tremelimumab | Blood samples will be collected to determine the concentration of tremelimumab. | Not Posted | Mar 2027 | Up to approximately 27 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab | Blood samples were collected to determine the presence of ADAs for durvalumab using validated assays. Treatment-emergent ADA-positive was defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Number of participants with treatment-emergent ADA (ADA incidence) are presented. | The ADA population included all participants in the safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result of the study drug. | Posted | Count of Participants | Participants | From first dose of study drug (Day 1) up to DCO date 15 January 2024 (a maximum of approximately 1936 days) |
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| Secondary | Durvalumab Plus Tremelimumab: Number of Participants With Anti-Drug Antibody (ADA) Response to Tremelimumab | Blood samples will be collected to determine the presence of ADAs for tremelimumab using validated assays. Treatment-emergent ADA-positive is defined as either treatment-induced (post-baseline ADA-positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to ≥4 fold during the study period). Treatment-boosted ADA is defined as a baseline positive ADA titer that was boosted to a 4-fold or higher level (greater than the analytical variance of the assay) following drug administration. Treatment-induced ADA is defined as ADA positive post-baseline and not detected at baseline. | Not Posted | Mar 2027 | Up to approximately 30 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Durvalumab Versus Durvalumab Plus Tremelimumab: Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Status Based on Progression-Free Survival, Overall Survival, and Objective Response Rate | Blood samples will be collected for clinical biomarker testing and a tumor specimen will be collected as per tumor specimen collection requirements. The specimen will be evaluated by immunohistochemistry to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and will be assessed using the VENTANA PD-L1 (SP263) assay. | Not Posted | Mar 2027 | Up to approximately 89 months | Participants |
From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.
All-cause mortality was assessed for FAS. 1 participant randomized to Durvalumab arm received 2 cycles of tremelimumab and in accordance with SAP was therefore not included in Durva or placebo safety population; will be included in D+T safety population when D+T arm is unblinded.
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 | Participants received durvalumab monotherapy (1500 mg for participants >30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants <=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. | 115 | 264 | 78 | 262 | 209 | 262 |
| EG001 | Durvalumab Plus Tremelimumab | Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants >30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants <=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Placebo | Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first. | 146 | 266 | 64 | 265 | 196 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Oesophageal achalasia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Peptic ulcer | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
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| Device related thrombosis | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hernia | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Greater trochanteric pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the hypopharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA version 26.1 | Systematic Assessment |
| |
| Alcoholic psychosis | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded IDMC), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2023 | Jul 31, 2025 | SAP_004.pdf |
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D002277 | Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not Hispanic or Latino |
|
| Missing |
|
|
|
|
|
|
Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
|
|
Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|