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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002931-35 | EudraCT Number |
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The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (Durvalumab monotherapy) | Experimental | durvalumab IV |
|
| Arm A (durvalumab + oleclumab): | Experimental | durvalumab IV and oleclumab IV |
|
| Arm B (durvalumab + monalizumab) | Experimental | durvalumab IV and monalizumab IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab + Oleclumab | Drug | Durvalumab + Oleclumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. | ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents | The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events | From time of signature of informed consent up to 15 months post the first dose of study treatment |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | 92801 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40663352 | Derived | Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Pillet M, Brown M, Paliompeis C, Dowson A, Cooper ZA, Kumar R, Herbst RS. Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non-Small Cell Lung Cancer: Update From the COAST Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518440. doi: 10.1001/jamanetworkopen.2025.18440. | |
| 35452273 |
| Label | URL |
|---|---|
| CSP redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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The first participant was randomized into the study on 3 January 2019 and the last participant was randomized on 6 July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm (Durvalumab Monotherapy) | Durvalumab 1500 mg IV monotherapy Q4W |
| FG001 | Arm A (Durvalumab + Oleclumab) | Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3) |
| 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 | Jul 27, 2021 | Aug 23, 2024 |
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At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.
Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.
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| Durvalumab | Drug | Durvalumab |
|
|
| Durvalumab + Monalizumab | Drug | Durvalumab + Monalizumab |
|
|
| Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents |
The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values |
| From baseline up to 15 months post the first dose of study treatment |
| Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents | The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events | From baseline up to 15 months post the first dose of study treatment |
| Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
| Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1. | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
| Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
| Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization. | PFS rate at 12 months after randomization. |
| Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | OS was defined as the time from the date of randomization until death due to any cause. | From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023). |
| Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents | Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate. | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| Pharmacokinetics of Novel Agents in Combination With Durvalumab | Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate. | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents | ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA. | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab | ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA. | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| Duarte |
| California |
| 91010 |
| United States |
| Research Site | Sacramento | California | 95825 | United States |
| Research Site | New Haven | Connecticut | 06510 | United States |
| Research Site | West Haven | Connecticut | 06516 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Orlando | Florida | 32804 | United States |
| Research Site | Winter Haven | Florida | 33881 | United States |
| Research Site | Wichita | Kansas | 67214 | United States |
| Research Site | Lexington | Kentucky | 40503 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | Covington | Louisiana | 70433 | United States |
| Research Site | Rosedale | Maryland | 21237 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Portland | Oregon | 97227-1191 | United States |
| Research Site | Gettysburg | Pennsylvania | 17325 | United States |
| Research Site | Lancaster | Pennsylvania | 17601 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Sioux Falls | South Dakota | 57105 | United States |
| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | Memphis | Tennessee | 38120 | United States |
| Research Site | Tyler | Texas | 75701 | United States |
| Research Site | Salt Lake City | Utah | 84112 | United States |
| Research Site | Richmond | Virginia | 23230 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Bron | 69677 | France |
| Research Site | Créteil | 94010 | France |
| Research Site | La Rochelle | 17019 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Limoges | 87042 | France |
| Research Site | Lyon | 69004 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Nice | 06189 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Rennes | 35033 | France |
| Research Site | Strasbourg | 67065 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Hong Kong | Hong Kong |
| Research Site | Jordan | Hong Kong |
| Research Site | Kowloon | Hong Kong |
| Research Site | Catania | 95125 | Italy |
| Research Site | Cremona | 26100 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Palermo | 90127 | Italy |
| Research Site | Ravenna | 48121 | Italy |
| Research Site | Siena | 53100 | Italy |
| Research Site | Gdynia | 81-519 | Poland |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Lodz | 90-242 | Poland |
| Research Site | Lisbon | 1400-038 | Portugal |
| Research Site | Lisbon | 1500-650 | Portugal |
| Research Site | Porto | 4099-001 | Portugal |
| Research Site | Porto | 4200-072 | Portugal |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Badajoz | 06008 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 08041 | Spain |
| Research Site | Barcelona | 08916 | Spain |
| Research Site | Castellon | 12002 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Valencia | 46014 | Spain |
| Research Site | Chiayi City | 61363 | Taiwan |
| Research Site | Taichung | 402 | Taiwan |
| Derived |
| Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22. |
| SAP redacted | View source |
| CSR Synopsis redacted | View source |
| FG002 | Arm B (Durvalumab + Monalizumab) | Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm (Durvalumab Monotherapy) | Durvalumab 1500 mg IV monotherapy Q4W |
| BG001 | Arm A (Durvalumab + Oleclumab) | Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3) |
| BG002 | Arm B (Durvalumab + Monalizumab) | Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group | Posted | Number | 95% Confidence Interval | Percentage of Participants | ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents | The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events | The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received. | Posted | Count of Participants | Participants | From time of signature of informed consent up to 15 months post the first dose of study treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents | The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values | The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received. | Posted | Count of Participants | Participants | From baseline up to 15 months post the first dose of study treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents | The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events | The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received. | Posted | Count of Participants | Participants | From baseline up to 15 months post the first dose of study treatment |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group. Only participants with an objective response were included in the DoR analysis. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1. | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group | Posted | Median | 95% Confidence Interval | Months | Up to approximately 54 months (through the database cutoff date of 18-Jul-2023). |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization. | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group | Posted | Number | 95% Confidence Interval | Percentage of Participants | PFS rate at 12 months after randomization. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | OS was defined as the time from the date of randomization until death due to any cause. | The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group | Posted | Median | 95% Confidence Interval | Months | From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023). |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents | Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate. | The PK-evaluable durvalumab population included participants from the As-treated population who had a non-missing baseline PK durvalumab concentration and at least one non-missing post-baseline PK durvalumab concentration | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Novel Agents in Combination With Durvalumab | Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate. | The PK-evaluable oleclumab/monalizumab population included participants from the As-treated population who had a non-missing baseline PK oleclumab/monalizumab concentration and at least one non-missing post-baseline PK oleclumab/monalizumab concentration | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents | ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA. | The durvalumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline durvalumab ADA result and at least one non-missing post-baseline durvalumab ADA result | Posted | Count of Participants | Participants | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab | ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA. | The oleclumab/monalizumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline oleclumab/monalizumab ADA result and at least one non-missing post-baseline oleclumab/monalizumab ADA result | Posted | Count of Participants | Participants | From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1 |
|
AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
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 Monotherapy | Description (Arm-group) | 27 | 66 | 23 | 66 | 61 | 66 |
| EG001 | Durvalumab + Oleclumab | Description (Arm-group) | 23 | 59 | 20 | 59 | 52 | 59 |
| EG002 | Durvalumab + Monalizumab | Description (Arm-group) | 24 | 61 | 17 | 61 | 58 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Periorbital infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary valve stenosis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2023 | Aug 23, 2024 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C000709515 | monalizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Missing |
|
| France |
|
| Hong-Kong |
|
| Italy |
|
| Portugal |
|
| Spain |
|
| Taiwan |
|
| United States |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3) |
| OG002 | Arm B (Durvalumab + Monalizumab) | Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W |
|
|
| Arm B (Durvalumab + Monalizumab) |
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W |
|
|