Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment in the study was prematurely terminated due to recruitment challenges and not due to concerns of safety for the participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
The study was intended to be a phase I/II trial, but the study never moved forward to Phase II due to recruitment challenges.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M3814 PiC with Etoposide and Cisplatin | Experimental | Participants received M3814 100 milligram (mg) powder in capsule (PiC) orally once daily in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 milligram per square meter (mg/m^2) over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until progressive disease (PD). |
|
| M3814 (HME Tablet + PiC) with Etoposide and Cisplatin | Experimental | Participants received M3814 100 mg hot melt extrusion (HME) tablet orally 5 days prior to Day 1 and M3814 100 mg PiC, orally once daily from Day 1 in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 mg/m^2 over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until PD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M3814 | Drug | Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. | up to 21 days | |
| Phase Ib: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of M3814 in Combination With Cisplatin and Etoposide for the Phase II Part of the Study | up to 11 months | |
| Phase II: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1 | PFS time will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. | Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. |
Not provided
Inclusion Criteria:
To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria:
Exclusion Criteria:
Participants are not eligible for the study if they fulfill any of the following exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Mesa | Arizona | 85206 | United States | ||
| Research site 1 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cisplatin | Drug | Cisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1. |
|
| Etoposide | Drug | Etoposide 100 mg/m^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days). |
|
| From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase Ib: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs) | Subjects will be analyzed for vital signs (eg, body temperature, respiratory rate, heart rate, and blood pressure), laboratory parameters and 12-lead ECG recorded at baseline and after administration of M3814. Number of subjects with abnormal values for laboratory values, vital signs and electrocardiograms (ECGs) will be reported. | From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase Ib: Change in Eastern Cooperative Oncology Group performance status (ECOG PS) | From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase Ib: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1 | The Objective Response Rate (ORR) is defined as the percentage of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the Investigator. | Post randomization with period tumor evaluations until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy, assessed up to 11 months |
| Phase Ib: Duration of Response (DoR) According to RECIST v1.1 | The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator. | First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months |
| Phase Ib: Percentage of Subjects With Disease Control | Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported. | First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months |
| Phase Ib: Progression Free Survival (PFS) According to RECIST v1.1 | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. The PFS will be derived according to RECIST v1.1 as assessed by the Investigator. | Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 11 months |
| Phase Ib: Overall Survival (OS) | The OS time is defined as the date from randomization to death due to any cause. | Time from randomization to death due to any cause, assessed up to 11 months |
| Phase Ib: Area under the concentration-time curve from 0 to 4 hours (AUC 0-4), 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide | Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose, C3D1 Pre-dose and 3.5 hrs post dose |
| Phase Ib: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide | Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase Ib: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose |
| Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose |
| Phase Ib: Apparent Terminal Half-life (t1/2) for M3814 | C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose |
| Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814 | C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose |
| Phase Ib: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814 | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose |
| Phase Ib: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hr post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase Ib: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814 | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase Ib: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase Ib: Terminal rate constant (λz) for M3814, Cisplatin and Etoposide | Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase Ib: Changes in Cmax for M3814 Between Day -1 and C2D1 | Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase Ib: Changes in AUC for M3814 Between Day -1 and C2D1 | Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase Ib: Changes in AUC for Etoposide From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels) | Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase Ib: Changes in Cmax for Etoposide From C1D1 and C2D1 | Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase Ib: Changes in AUC for Cisplatin From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels) | Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase Ib: Changes in Cmax for Cisplatin From C1D1 and C2D1 | Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose |
| Phase II: Overall Survival (OS) | Time from randomization to death due to any cause, assessed up to 24 months |
| Phase II: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1 | The Objective Response Rate (ORR) is defined as the proportion of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) Version 1.1 as assessed by the Investigator. | Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months |
| Phase II: Duration of Response (DoR) According to RECIST v1.1 | The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator. | First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months |
| Phase II: Percentage of Subjects With Disease Control | Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported. | First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months |
| Phase II: Percentage of Subjects Who Received Prophylactic Cranial Irradiation (PCI) and/or Thorax Irradiation After 6 Cycles of Treatment | After 6 Cycles of treatment, assessed up to 24 months |
| Phase II: Tumor shrinkage From Baseline in target lesions | Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months |
| Phase II: Number of subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase II: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs) | From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase II: Change in Eastern Cooperative Oncology Group performance status (ECOG PS) | From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment |
| Phase II: Primary Health-Related Quality of Life (HRQoL) Based on Time to Definitive Deterioration (TUDD) as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) | Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months |
| Phase II: Primary HRQoL based on TUDD Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months |
| Phase II: Primary HRQoL based on TUDD Assessed Using European Quality of Life 5- dimensions questionnaire (EQ-5D) | Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months |
| Phase II: Area under the concentration-time curve from 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Apparent Terminal Half-life (t1/2) for M3814 | C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose |
| Phase II: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814 | C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose |
| Phase II: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814 | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide | Time Frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814 | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Phase II: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide | C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose |
| Santa Rosa |
| California |
| 95403 |
| United States |
| Research site | Santa Rosa | California | 95403 | United States |
| Research site | Whittier | California | 90603 | United States |
| Research site | Danbury | Connecticut | 06810 | United States |
| Research site | Norwalk | Connecticut | 06850 | United States |
| Research site | Columbus | Georgia | 31904 | United States |
| Research site | Newnan | Georgia | 30265 | United States |
| Research site | Topeka | Kansas | 66606 | United States |
| Research site | Ashland | Kentucky | 41101 | United States |
| Research site | Billings | Montana | 59101 | United States |
| Research site | Pinehurst | North Carolina | 28374 | United States |
| Research site | Cincinnati | Ohio | 45229 | United States |
| Research site | Portland | Oregon | 97213 | United States |
| Research site | Philadelphia | Pennsylvania | 19124 | United States |
| Research site | Houston | Texas | 77030 | United States |
| Research site | Aalst | 9300 | Belgium |
| Research site | Charleroi | 6000 | Belgium |
| Research site | Edegem | 2650 | Belgium |
| Research site | Ghent | 9000 | Belgium |
| Research site | Libramont | 6800 | Belgium |
| Research site | Liège | 4000 | Belgium |
| Research site | Roeselare | 8800 | Belgium |
| Research site | Yvoir | 5530 | Belgium |
| Research site 4 | Sofia | 1330 | Bulgaria |
| Research site 2 | Sofia | 1407 | Bulgaria |
| Research site 6 | Sofia | 1431 | Bulgaria |
| Reasearch site 5 | Sofia | 1527 | Bulgaria |
| Research site 3 | Sofia | 1632 | Bulgaria |
| Research site 1 | Sofia | 1784 | Bulgaria |
| Research site | Calgary | Alberta | T2N 4N2 | Canada |
| Research site | Saint John | New Brunswick | E2L 4L2 | Canada |
| Research site | London | Ontario | N6A 5W9 | Canada |
| Research site | Toronto | Ontario | M5G 2M9 | Canada |
| Research site | Benešov | 256 01 | Czechia |
| Research site | Olomouc | 775 20 | Czechia |
| Research site | Aalborg | 9100 | Denmark |
| Research site | Herlev | 2730 | Denmark |
| Research site | Odense C | 5000 | Denmark |
| Research site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Research site | Gauting | Bavaria | 82131 | Germany |
| Research site | Nuremberg | Bavaria | 90419 | Germany |
| Research site | Hanover | Lower Saxony | 30625 | Germany |
| Research site | Chemnitz | Saxony | 9113 | Germany |
| Research site | Kiel | Schleswig-Holstein | 24105 | Germany |
| Research site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Research site 1 | Berlin | 10117 | Germany |
| Research site 2 | Berlin | 10967 | Germany |
| Research site 1 | Budapest | 1121 | Hungary |
| Research site 2 | Budapest | 1121 | Hungary |
| Research site 3 | Budapest | 1125 | Hungary |
| Research site | Farkasgyepű | 8582 | Hungary |
| Research site | Szekszárd | 7100 | Hungary |
| Research site | Szolnok | 5000 | Hungary |
| Research site | Rozzano | Milano | 20089 | Italy |
| Research site | Catania | 95123 | Italy |
| Research site | Genova | 16132 | Italy |
| Research site | Naples | 80131 | Italy |
| Research site | Ravenna | 48121 | Italy |
| Research site | Reggio Emilia | 42100 | Italy |
| Research site | Roma | 168 | Italy |
| Research site | Torino | 10126 | Italy |
| Research site | Olsztyn | 10-357 | Poland |
| Research site | Poznan | 60-569 | Poland |
| Research site | Warsaw | 02-781 | Poland |
| Research site | Wodzisław Śląski | 44-300 | Poland |
| Research site | Baia Mare | 430291 | Romania |
| Research site | Cluj-Napoca | 400015 | Romania |
| Research site | Cluj-Napoca | 400058 | Romania |
| Research site | Craiova | 200347 | Romania |
| Research site | Timișoara | 300210 | Romania |
| Research site | Badajoz | 6080 | Spain |
| Research site 1 | Madrid | 28040 | Spain |
| Research site 4 | Madrid | 28040 | Spain |
| Research site 3 | Madrid | 28046 | Spain |
| Research site 2 | Madrid | 28050 | Spain |
| Research site | Hull | East Riding Of Yorkshire | HU16 5JQ | United Kingdom |
| Research site | London | Greater London | W1G 6AD | United Kingdom |
| Research site | Sheffield | South Yorkshire | S10 2SJ | United Kingdom |
| Research site | Glasgow | Strathclyde | G12 OYN | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000716216 | peposertib |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided