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Studie zu Atezolizumab plus Carboplatin und Etoposid mit oder ohne Tiragolumab bei Teilnehmern mit unbehandeltem kleinzelligem Lungenkrebs im ausgedehnten Stadium (SKYSCRAPER-02C)

15. September 2026 aktualisiert von: Hoffmann-La Roche

Eine randomisierte, doppelblinde, placebokontrollierte Phase-III-Studie mit Atezolizumab plus Carboplatin und Etoposid mit oder ohne Tiragolumab bei Patienten mit unbehandeltem kleinzelligem Lungenkrebs im ausgedehnten Stadium

Der Zweck dieser multizentrischen Studie in China ist die Bewertung der Sicherheit und Wirksamkeit von Tiragolumab plus Atezolizumab und Carboplatin und Etoposid (CE) im Vergleich zu Placebo plus Atezolizumab und CE bei Teilnehmern mit unbehandeltem kleinzelligem Lungenkrebs im ausgedehnten Stadium.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

123

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 101149
        • Beijing Chest Hospital
      • Bengbu, China, 233000
        • the First Affiliated Hospital of Bengbu Medical College
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Fuzhou, China, 350014
        • Fujian Provincial Cancer Hospital
      • Guangzhou, China, 510000
        • Cancer Center of Guangzhou Medical University
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanchang, China, 330006
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Shanghai, China, 200000
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200120
        • Fudan University Shanghai Cancer Center
      • Shantou, China, 515041
        • Cancer Hospital of Shantou University Medical College
      • Wuhan, China, 430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von 0 oder 1
  • Histologisch oder zytologisch bestätigter kleinzelliger Lungenkrebs im ausgedehnten Stadium (ES-SCLC) gemäß dem modifizierten Staging-System der Veterans Administration Lung Study Group (VALG).
  • Keine vorherige systemische Behandlung für ES-SCLC
  • Für Teilnehmer, die eine vorherige Chemoradiotherapie für SCLC im begrenzten Stadium erhalten haben, muss eine Behandlung mit kurativer Absicht und ein behandlungsfreies Intervall von mindestens 6 Monaten zwischen der letzten Dosis/Zyklus der Chemotherapie, Thoraxbestrahlung oder Radiochemotherapie und der Diagnose von ES- SCLC
  • Messbare Krankheiten gemäß RECIST v1.1
  • Einreichung einer Tumorgewebeprobe vor der Behandlung
  • Angemessene hämatologische und Endorganfunktion
  • Teilnehmer, die keine therapeutische Antikoagulation mit international normalisierter Ratio (INR) und aktivierter Gerinnungszeit (aPTT) erhalten
  • Teilnehmer, die eine therapeutische Antikoagulation erhalten: stabiles Antikoagulans-Regime
  • Negativer HIV-Test (Human Immunodeficiency Virus) beim Screening
  • Negativer Hepatitis-B-Oberflächenantigen (HBsAg)-Test beim Screening
  • Positiver Hepatitis-B-Oberflächenantikörper (HBsAb)-Test beim Screening oder negativer HBsAb beim Screening, begleitet von einem der folgenden: negativer Gesamt-Hepatitis-B-Core-Antikörper (HBcAb) und/oder positiver Gesamt-HBcAb-Test, gefolgt von einem negativen Hepatitis-B-Virus (HBV) DNA-Test
  • Negativer Hepatitis-C-Virus (HCV)-Antikörpertest beim Screening oder positiver HCV-Antikörpertest, gefolgt von einem negativen HCV-RNA-Test
  • Negativer Epstein-Barr-Virus (EBV)-Viruscapsid-Antigen (VCA)-IgM-Test oder negativer EBV-Polymerase-Kettenreaktionstest (PCR) beim Screening
  • Für Frauen im gebärfähigen Alter: Zustimmung zur Abstinenz (Verzicht auf heterosexuellen Verkehr) oder zur Anwendung von Verhütungsmitteln und Zustimmung zum Verzicht auf Eizellspende
  • Für Männer: Zustimmung zur Abstinenz (Unterlassung heterosexuellen Geschlechtsverkehrs) oder zur Anwendung von Verhütungsmethoden und Zustimmung zum Verzicht auf Samenspende.

Ausschlusskriterien:

  • Symptomatische oder aktiv fortschreitende Metastasen im Zentralnervensystem (ZNS).
  • Kompression des Rückenmarks
  • Leptomeningeale Krankheit
  • Unkontrollierter Pleuraerguss, Perikarderguss oder Aszites
  • Unkontrollierte oder symptomatische Hyperkalzämie
  • Bekannte klinisch signifikante Lebererkrankung, einschließlich aktiver viraler, alkoholischer oder anderer Hepatitis, Zirrhose und erblicher Lebererkrankung oder aktueller Alkoholmissbrauch
  • Andere Malignome als SCLC innerhalb von 5 Jahren vor der Randomisierung
  • Aktive oder Vorgeschichte einer Autoimmunerkrankung oder Immunschwäche
  • Vorgeschichte von idiopathischer Lungenfibrose, organisierender Pneumonie, arzneimittelinduzierter Pneumonitis oder idiopathischer Pneumonitis oder Nachweis einer aktiven Pneumonitis bei Screening-Computertomographie (CT) des Brustkorbs
  • Bekannte aktive Tuberkulose, Aktuelle Behandlung mit antiviraler Therapie für HBV oder HCV
  • Schwere chronische oder aktive Infektion
  • Behandlung mit therapeutischen oralen oder intravenösen Antibiotika
  • Bedeutende Herz-Kreislauf-Erkrankung
  • Größerer chirurgischer Eingriff außer zur Diagnose
  • Vorherige allogene Knochenmarktransplantation oder solide Organtransplantation
  • Alle anderen Krankheiten, Stoffwechselstörungen, körperliche Untersuchungsbefunde oder klinische Laborbefunde, die den begründeten Verdacht auf eine Krankheit oder einen Zustand begründen
  • Verabreichung eines attenuierten Lebendimpfstoffs
  • Vorbehandlung mit CD137-Agonisten, T-Zell-Co-stimulierenden oder Immun-Checkpoint-Blockade-Therapien
  • Behandlung mit systemischen immunstimulierenden Mitteln
  • Behandlung mit systemischen immunsuppressiven Medikamenten
  • Vorgeschichte schwerer allergischer anaphylaktischer Reaktionen auf chimäre oder humanisierte Antikörper oder Fusionsproteine
  • Bekannte Überempfindlichkeit gegen Ovarialzellen des Chinesischen Hamsters (CHO) oder gegen einen Bestandteil der Tiragolumab- oder Atezolizumab-Formulierungen
  • Vorgeschichte von allergischen Reaktionen auf Carboplatin oder Etoposid
  • Schwangerschaft oder Stillzeit oder beabsichtigte Schwangerschaft während der Studienbehandlung oder innerhalb von 5 Monaten nach der letzten Dosis von Atezolizumab oder innerhalb von 90 Tagen nach der letzten Dosis von Tiragolumab oder für 6 Monate nach der letzten Dosis von Carboplatin oder Etoposid.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Tiragolumab + Atezolizumab + Carboplatin und Etoposid
Die Induktionsbehandlung mit Tiragolumab plus Atezolizumab und CE wird in einem 21-Tage-Zyklus für 4 Zyklen verabreicht. Nach der Induktionsphase setzen die Teilnehmer die Erhaltungstherapie mit Tiragolumab plus Atezolizumab für 21-tägige Zyklen fort.
Arzneimittel: Tiragolumab
Tiragolumab in einer festen Dosis von 600 Milligramm (mg), verabreicht als intravenöse (IV) Infusion, alle 3 Wochen (Q3W) an Tag 1 jedes 21-tägigen Zyklus.
Andere Namen:
  • MTIG7192A
Arzneimittel: Atezolizumab
Atezolizumab in einer festen Dosis von 1200 mg, verabreicht als IV-Infusion, Q3W an Tag 1 jedes 21-tägigen Zyklus.
Andere Namen:
  • Tecentriq
Arzneimittel: Carboplatin
Carboplatin wurde i.v. verabreicht, um einen anfänglichen Zielbereich unter der Konzentrations-Zeit-Kurve (AUC) von 5 mg/ml/min, Q3W, an Tag 1 jedes 21-Tage-Zyklus für 4 Zyklen zu erreichen.
Arzneimittel: Etoposid
Etoposid 100 mg/m^2, verabreicht als IV-Infusion, Q3W an Tag 1, 2 und 3 jedes 21-Tage-Zyklus für 4 Zyklen.
Placebo-Komparator: Placebo + Atezolizumab + Carboplatin und Etoposid
Die Induktionsbehandlung mit Placebo plus Atezolizumab und CE wird in einem 21-Tage-Zyklus für 4 Zyklen verabreicht. Nach der Induktionsphase setzen die Teilnehmer die Erhaltungstherapie mit Placebo plus Atezolizumab für 21-tägige Zyklen fort
Arzneimittel: Atezolizumab
Atezolizumab in einer festen Dosis von 1200 mg, verabreicht als IV-Infusion, Q3W an Tag 1 jedes 21-tägigen Zyklus.
Andere Namen:
  • Tecentriq
Arzneimittel: Carboplatin
Carboplatin wurde i.v. verabreicht, um einen anfänglichen Zielbereich unter der Konzentrations-Zeit-Kurve (AUC) von 5 mg/ml/min, Q3W, an Tag 1 jedes 21-Tage-Zyklus für 4 Zyklen zu erreichen.
Arzneimittel: Etoposid
Etoposid 100 mg/m^2, verabreicht als IV-Infusion, Q3W an Tag 1, 2 und 3 jedes 21-Tage-Zyklus für 4 Zyklen.
Arzneimittel: Tiragolumab, passendes Placebo
Passendes Placebo, verabreicht als IV-Infusion, Q3W an Tag 1 jedes 21-Tage-Zyklus.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)
Zeitfenster: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first in the PAS. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 millimeters (mm) and unequivocal progression of existing non-target lesions. Kalpan-Meier (K-M) method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Overall Survival (OS) in the PAS
Zeitfenster: From randomization to death from any cause (up to approximately 32.3 months)
OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 32.3 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Investigator-assessed PFS in the FAS
Zeitfenster: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
PFS was defined as the time from randomization to the first occurrence of PD, as assessed by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the FAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the sum must also demonstrate an absolute increase of ≥ 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
OS in the FAS
Zeitfenster: From randomization to death from any cause (up to approximately 32.3 months)
OS was defined as the time from randomization to death from any cause in the FAS. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 32.3 months)
Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS
Zeitfenster: Up to approximately 32.3 months
ORR was defined as the percentage of participants with an objective response (OR), characterized by a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as assessed by the investigator according to RECIST v.1.1 in the PAS. CR was defined as the disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 32.3 months
Investigator-assessed Confirmed ORR in the FAS
Zeitfenster: Up to approximately 32.3 months
ORR was defined as the percentage of participants with an OR, characterized by a confirmed CR or PR on two consecutive occasions ≥4 weeks apart, as assessed by the investigator according to RECIST v.1.1 in the FAS. CR was defined as the disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.
Up to approximately 32.3 months
Investigator-assessed Duration of Response (DOR) in the PAS
Zeitfenster: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first in the PAS. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed DOR in the FAS
Zeitfenster: From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first in the FAS. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median DOR.
From first occurrence of a documented OR to PD or death from any cause, whichever occurred first (up to approximately 32.3 months)
Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS
Zeitfenster: At Months 6 and 12
PFS rate at 6 months and 12 months was defined as the percentage of participants who did not experience PD as determined by the investigator according to RECIST v1.1, or death from any cause at Months 6 and 12 in the PAS. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the PAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off.
At Months 6 and 12
Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS
Zeitfenster: At Months 6 and 12
PFS rate at 6 months and 12 months was defined as the percentage of participants who did not experience PD, as determined by the investigator according to RECIST v1.1 or death from any cause, at Months 6 and 12 in the FAS. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first in the FAS. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off.
At Months 6 and 12
OS Rate at 12 Months and 24 Months in the PAS
Zeitfenster: At Months 12 and 24
OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at the specified timepoints in the PAS. OS was defined as the time from randomization to death from any cause in the PAS. K-M method was used to estimate OS rate. Percentages have been rounded off.
At Months 12 and 24
OS Rates at 12 Months and 24 Months in the FAS
Zeitfenster: At Months 12 and 24
OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at the specified timepoints in the FAS. OS was defined as the time from randomization to death from any cause in the FAS. K-M method was used to estimate OS rate. Percentages have been rounded off.
At Months 12 and 24
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF) and Global Health Status (GHS), as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Core 30 (EORTC QLQ-C30) in the PAS
Zeitfenster: Up to approximately 32.3 months
TTCD=time from randomization to first confirmed clinically meaningful deterioration (CCMD) in PAS. EORTC QLQ-C30=cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, social), 3 symptom scales (fatigue, nausea, vomiting, pain), GHS/quality-of-life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). PF was scored on 4-point scale: 1=Not at all to 4=Very much. GHS/QoL was scored on 7-point scale: 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score for PF or GHS/QoL scale=high/healthy level of functioning/better health-related quality-of-life (HRQoL). CCMD= ≥ 10-point decrease from baseline in PF or GHS scale score held for at least 2 consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. K-M method was used to estimate median TTCD.
Up to approximately 32.3 months
TTCD in Participant-reported PF and GHS, as Measured by Respective Scales of EORTC QLQ-C30 in the FAS
Zeitfenster: Up to approximately 32.3 months
TTCD was defined as time from randomization to first CCMD in FAS. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, social), 3 symptom scales (fatigue, nausea, vomiting, pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). PF was scored on 4-point scale: 1=Not at all to 4=Very much. GHS/QoL was scored on 7-point scale: 1=Very poor to 7=Excellent. Scores were linearly transformed to range of 0-100. High score for PF or GHS/QoL scale=high/healthy level of functioning/better HRQoL. CCMD was defined as ≥ 10-point decrease from baseline in PF or GHS scale score held for at least 2 consecutive assessments or an initial clinically meaningful decrease from baseline followed by death from any cause within 3 weeks. K-M method was used to estimate median TTCD.
Up to approximately 32.3 months
Number of Participants With Adverse Events (AEs)
Zeitfenster: Up to approximately 57 months
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 1 participant randomized to the tiragolumab arm did not receive any dose of tiragolumab and was moved to the placebo arm for safety analysis.
Up to approximately 57 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
Zeitfenster: Up to approximately 57 months
CRS was defined as supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: Fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: Fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: Fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: Fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Up to approximately 57 months
Serum Concentration of Tiragolumab at Specified Timepoints
Zeitfenster: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-end of infusion (EOI) on Day 1 of Cycle 1; Treatment discontinuation visit(TDV) (up to approximately 32.3 months) (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-end of infusion (EOI) on Day 1 of Cycle 1; Treatment discontinuation visit(TDV) (up to approximately 32.3 months) (1 Cycle=21 days)
Serum Concentration of Atezolizumab at Specified Timepoints
Zeitfenster: Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-EOI on Day 1 of Cycle 1; TDV (up to approximately 32.3 months) (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16; 30 minutes-EOI on Day 1 of Cycle 1; TDV (up to approximately 32.3 months) (1 Cycle=21 days)
Maximum Plasma Concentration (Cmax) of Tiragolumab
Zeitfenster: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle=21 days)
Only sparse pharmacokinetic samples were collected in this study. With the focus on only Cmax and Cmin, there are no additional PK timepoints not reported.
30 mins-EOI on Day 1 of Cycle 1 (1 Cycle=21 days)
Minimum Plasma Concentration (Cmin) of Tiragolumab
Zeitfenster: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Cmax of Atezolizumab
Zeitfenster: 30 mins-EOI on Day 1 of Cycle 1 (1 Cycle= 21 days)
30 mins-EOI on Day 1 of Cycle 1 (1 Cycle= 21 days)
Cmin of Atezolizumab
Zeitfenster: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 (1 Cycle=21 days)
Number of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Zeitfenster: Up to approximately 32.3 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 32.3 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Ermittler

  • Studienleiter: Clinical Trials, Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. Dezember 2020

Primärer Abschluss (Tatsächlich)

31. August 2023

Studienabschluss (Tatsächlich)

17. November 2025

Studienanmeldedaten

Zuerst eingereicht

7. Dezember 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Dezember 2020

Zuerst gepostet (Tatsächlich)

14. Dezember 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YO42373

Plan für individuelle Teilnehmerdaten (IPD)

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JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über die Datenanforderungsplattform für klinische Studien (www.vivli.org) Zugang zu individuellen Patientendaten beantragen. Weitere Einzelheiten zu den Roche-Kriterien für förderfähige Studien finden Sie hier (https://vivli.org/ourmember/roche/). Weitere Einzelheiten zu Roches Global Policy on the Sharing of Clinical Information und zur Beantragung des Zugriffs auf zugehörige klinische Studiendokumente finden Sie hier (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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