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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517926-25-00 | Registry Identifier | EU CT | |
| MK-6070-002 | Other Identifier | MSD | |
| jRCT2031250039 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.
The goals of this study are to learn:
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Arm 1: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Part 1 Arm 2: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Part 1 Arm 3a: I-DXd Monotherapy | Experimental | Participants will receive I-DXd until documented disease progression or discontinuation criteria are met. |
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| Part 1 Arm 3b: Gocatamig and I-DXd | Experimental | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Part 2 Arm 4: Gocatamig Monotherapy in Japan | Experimental | Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gocatamig | Biological | IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented. | Up to approximately 44 months |
| Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) | A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented. | Up to approximately 3 weeks |
| Number of Participants Who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented. | Up to approximately 44 months |
| Part 1: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR) | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus ( Site 1110) | Recruiting | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consists of four arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig evaluated at different dosing intervals across two additional study arms). Part 3 consists of a single arm (gocatamig and durvalumab).
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| Part 2 Arm 5: Gocatamig Monotherapy in China | Experimental | Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. |
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| Part 2 Arm 6: Gocatamig | Experimental | Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Part 3 Arm 7: Gocatamig and Durvalumab | Experimental | Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Part 2 Arm 8: Gocatamig (Alternate Presentation) | Experimental | Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. |
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| Ifinatamab Deruxtecan (I-DXd) | Biological | IV infusion |
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| Durvalumab | Biological | IV infusion |
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| Up to approximately 44 months |
| Up to approximately 44 months |
| Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented. | Up to approximately 44 months |
| Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented. | Up to approximately 44 months |
| Maximum Concentration (Cmax) of gocatamig | Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| Cmax of ifinatamab deruxtecan (I-DXd) | Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| Cmax of Anti-B7-H3 Antibody | Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| Cmax of Deruxtecan (DXd) | Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd). | At designated timepoints (up to approximately 44 months) |
| Cmax of Durvalumab | Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab. | At designated timepoints (up to approximately 44 months) |
| Time to maximum concentration (Tmax) of gocatamig | Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| Tmax of I-DXd | Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| Tmax of Anti-B7-H3 Antibody | Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| Tmax of DXd | Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig | AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| AUCt of I-DXd | AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| AUCt of Anti-B7-H3 Antibody | AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| AUCt of DXd | AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug payload Dxd. | At designated timepoints (up to approximately 44 months) |
| Terminal Half-Life (t1/2) of gocatamig | t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| t1/2 of I-DXd | t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| t1/2 of Anti-B7-H3 Antibody | t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| t1/2 of DXd | t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Steady State Maximum Concentration (Cmax,ss) of gocatamig | Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| Cmax,ss of I-DXd | Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| Cmax,ss of Anti-B7-H3 Antibody | Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| Cmax,ss of DXd | Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Cmax,ss of Durvalumab | Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab. | At designated timepoints (up to approximately 44 months) |
| Steady State Ctrough (Ctrough,ss) of gocatamig | Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| Ctrough,ss of I-DXd | Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| Ctrough,ss of Anti-B7-H3 Antibody | Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| Ctrough,ss of DXd | Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Ctrough,ss of Durvalumab | Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab. | At designated timepoints (up to approximately 44 months) |
| Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig | Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| Tmax,ss of I-DXd | Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| Tmax,ss of Anti-B7-H3 Antibody | Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| Tmax,ss of DXd | Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig | AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| AUCt,ss of I-DXd | AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| AUCt,ss of Anti-B7-H3 Antibody | AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| AUCt,ss of DXd | AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Steady state t1/2 (t1/2,ss) of gocatamig | t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| t1/2,ss of I-DXd | t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| t1/2,ss of Anti-B7-H3 Antibody | t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| t1/2,ss of DXd | t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Accumulation Ratio (AC) of gocatamig | Blood samples will be collected to determine the AC of the drug gocatamig. | At designated timepoints (up to approximately 44 months) |
| AC of I-DXd | Blood samples will be collected to determine the AC of the drug I-DXd. | At designated timepoints (up to approximately 44 months) |
| AC of Anti-B7-H3 Antibody | Blood samples will be collected to determine the AC of the anti-B7-H3 antibody. | At designated timepoints (up to approximately 44 months) |
| AC of DXd | Blood samples will be collected to determine the AC of the drug payload DXd. | At designated timepoints (up to approximately 44 months) |
| Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig | Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented. | At designated timepoints (up to approximately 44 months) |
| Incidence of ADAs Against I-DXd | Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented. | At designated timepoints (up to approximately 44 months) |
| Incidence of ADAs Against Durvalumab | Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented. | At designated timepoints (up to approximately 44 months) |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) | Recruiting | Miami | Florida | 33136 | United States |
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| University of Chicago ( Site 1108) | Recruiting | Chicago | Illinois | 60637 | United States |
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| Dana Farber Cancer Institute ( Site 1105) | Recruiting | Boston | Massachusetts | 02215 | United States |
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| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Roswell Park Cancer Institute ( Site 1107) | Recruiting | Buffalo | New York | 14263 | United States |
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| Providence Portland Medical Center ( Site 1101) | Recruiting | Portland | Oregon | 97213 | United States |
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| Sarah Cannon Research Institute ( Site 7001) | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Medical College of Wisconsin ( Site 1112) | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Hospital Universitario Austral ( Site 2204) | Recruiting | Pilar | Buenos Aires | B1629WWA | Argentina |
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| Sanatorio Parque ( Site 2203) | Recruiting | Rosario | Santa Fe Province | S2000DSV | Argentina |
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| Princess Alexandra Hospital ( Site 5300) | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Monash Health ( Site 5301) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| FALP ( Site 2100) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Pontificia Universidad Catolica de Chile ( Site 2102) | Recruiting | Santiago | Region M. de Santiago | 8330032 | Chile |
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| Bradfordhill ( Site 2101) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| Beijing Cancer Hospital ( Site 5401) | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Fujian Cancer Hospital ( Site 5413) | Recruiting | Fuzhou | Fujian | 350014 | China |
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| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Shanghai Chest Hospital ( Site 5400) | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Shanghai Pulmonary Hospital ( Site 5405) | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| West China Hospital of Sichuan University ( Site 5416) | Recruiting | Chengdu | Sichuan | 610041 | China |
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| The First Affiliated Hospital, Zhejiang University ( Site 5404) | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Rambam Health Care Campus ( Site 3202) | Active, not recruiting | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center ( Site 3200) | Recruiting | Jerusalem | 9103102 | Israel |
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| Rabin Medical Center ( Site 3203) | Recruiting | Petah Tikva | 4941492 | Israel |
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| Sheba Medical Center ( Site 3201) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Aichi Cancer Center ( Site 5000) | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
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| National Cancer Center Hospital East ( Site 5001) | Recruiting | Kashiwa | Chiba | 277-0882 | Japan |
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| Kansai Medical University Hospital ( Site 5004) | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
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| Cancer Institute Hospital of JFCR ( Site 5002) | Recruiting | Koto | Tokyo | 135-8550 | Japan |
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| Seoul National University Hospital ( Site 5100) | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital, Yonsei University Health System ( Site 5102) | Recruiting | Seoul | 03722 | South Korea |
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| Samsung Medical Center ( Site 5101) | Recruiting | Seoul | 06351 | South Korea |
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| HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) | Recruiting | Eixample | Barcelona | 08036 | Spain |
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| Institut Català d'Oncologia - L'Hospitalet ( Site 3317) | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| Hospital Clinico San Carlos... ( Site 3316) | Recruiting | Madrid | Madrid, Comunidad de | 28040 | Spain |
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| Hospital Universitari Vall d'Hebron ( Site 3311) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario HM Sanchinarro ( Site 3313) | Recruiting | Madrid | 28050 | Spain |
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| Hospital Universitario Virgen de la Victoria ( Site 3312) | Recruiting | Málaga | 29010 | Spain |
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| National Cheng Kung University Hospital ( Site 5202) | Recruiting | Tainan | 704 | Taiwan |
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| Taipei Medical University Hospital ( Site 5201) | Recruiting | Taipei | 11030 | Taiwan |
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| Hacettepe Universite Hastaneleri ( Site 3410) | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| Ankara Bilkent Sehir Hastanesi ( Site 3412) | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
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| National Institute for Health Research UCLH Clinical Research Facility ( Site 3902) | Recruiting | London | London, City of | W1T 7HA | United Kingdom |
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| The Clatterbridge Cancer Centre ( Site 3903) | Recruiting | Liverpool | L7 8YA | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 3901) | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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