Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Studio su Atezolizumab più carboplatino ed etoposide con o senza tiragolumab in partecipanti con carcinoma polmonare a piccole cellule in stadio esteso non trattato (SKYSCRAPER-02C)

15 settembre 2026 aggiornato da: Hoffmann-La Roche

Uno studio di fase III, randomizzato, in doppio cieco, controllato con placebo su atezolizumab più carboplatino ed etoposide con o senza tiragolumab in pazienti con carcinoma polmonare a piccole cellule in stadio esteso non trattato

Lo scopo di questo studio multicentrico in Cina è valutare la sicurezza e l'efficacia di tiragolumab più atezolizumab e carboplatino ed etoposide (CE) rispetto al placebo più atezolizumab e CE nei partecipanti con carcinoma polmonare a piccole cellule in stadio esteso non trattato.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

123

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Performance Status dell'Eastern Cooperative Oncology Group (ECOG) pari a 0 o 1
  • Carcinoma polmonare a piccole cellule in stadio esteso (ES-SCLC) confermato istologicamente o citologicamente secondo il sistema di stadiazione del Veterans Administration Lung Study Group (VALG) modificato
  • Nessun precedente trattamento sistemico per ES-SCLC
  • Per i partecipanti che hanno ricevuto una precedente chemioradioterapia per SCLC in stadio limitato devono aver ricevuto un trattamento con intento curativo e un intervallo libero da trattamento di almeno 6 mesi tra l'ultima dose/ciclo di chemioterapia, radioterapia toracica o chemioradioterapia e la diagnosi di ES- SCLC
  • Malattie misurabili come definite da RECIST v1.1
  • Presentazione di un campione di tessuto tumorale pre-trattamento
  • Adeguata funzionalità ematologica e degli organi terminali
  • Partecipanti che non ricevono anticoagulanti terapeutici con rapporto internazionale normalizzato (INR) e tempo di coagulazione attivato (aPTT)
  • Partecipanti che ricevono anticoagulanti terapeutici: regime anticoagulante stabile
  • Test del virus dell'immunodeficienza umana (HIV) negativo allo screening
  • Test dell'antigene di superficie dell'epatite B (HBsAg) negativo allo screening
  • Test dell'anticorpo di superficie dell'epatite B positivo (HBsAb) allo screening, o HBsAb negativo allo screening accompagnato da uno dei seguenti: anticorpo totale dell'epatite B negativo (HBcAb) e/o test HBcAb totale positivo seguito da un virus dell'epatite B negativo (HBV) Prova del DNA
  • Test per gli anticorpi del virus dell'epatite C (HCV) negativo allo screening o test per gli anticorpi per l'HCV positivo seguito da un test per l'RNA dell'HCV negativo
  • Negativo al test IgM dell'antigene del capside virale (VCA) del virus di Epstein-Barr (EBV) o al test di reazione a catena della polimerasi (PCR) dell'EBV negativo allo screening
  • Per le donne in età fertile: accordo a rimanere astinenti (astenersi da rapporti eterosessuali) o usare la contraccezione e accordo ad astenersi dal donare ovuli
  • Per gli uomini: consenso a mantenere l'astinenza (astenersi da rapporti eterosessuali) o utilizzare metodi contraccettivi e accordo a non donare sperma.

Criteri di esclusione:

  • Metastasi del sistema nervoso centrale (SNC) sintomatiche o in progressione attiva
  • Compressione del midollo spinale
  • Malattia leptomeningea
  • Versamento pleurico incontrollato, versamento pericardico o ascite
  • Ipercalcemia incontrollata o sintomatica
  • Malattia epatica clinicamente significativa nota, inclusa epatite virale attiva, alcolica o di altro tipo, cirrosi e malattia epatica ereditaria o abuso di alcol in corso
  • Tumori maligni diversi da SCLC entro 5 anni prima della randomizzazione
  • Attivo o storia di malattia autoimmune o deficienze immunitarie
  • Anamnesi di fibrosi polmonare idiopatica, polmonite organizzativa, polmonite indotta da farmaci o polmonite idiopatica o evidenza di polmonite attiva alla tomografia computerizzata del torace (TC) di screening
  • Tubercolosi attiva nota, trattamento in corso con terapia antivirale per HBV o HCV
  • Grave infezione cronica o attiva
  • Trattamento con antibiotici terapeutici orali o EV
  • Malattia cardiovascolare significativa
  • Procedura chirurgica maggiore diversa da quella diagnostica
  • Precedente trapianto allogenico di midollo osseo o trapianto di organi solidi
  • Qualsiasi altra malattia, disfunzione metabolica, risultato dell'esame fisico o risultato di laboratorio clinico che dia un ragionevole sospetto di una malattia o condizione
  • Somministrazione di un vaccino vivo attenuato
  • Trattamento precedente con agonisti del CD137, co-stimolazione delle cellule T o terapie di blocco del checkpoint immunitario
  • Trattamento con agenti immunostimolanti sistemici
  • Trattamento con farmaci immunosoppressori sistemici
  • Anamnesi di gravi reazioni anafilattiche allergiche ad anticorpi chimerici o umanizzati o proteine ​​di fusione
  • Ipersensibilità nota ai prodotti a base di cellule di ovaio di criceto cinese (CHO) o a qualsiasi componente delle formulazioni di tiragolumab o atezolizumab
  • Storia di reazioni allergiche al carboplatino o all'etoposide
  • Gravidanza o allattamento al seno o intenzione di iniziare una gravidanza durante il trattamento in studio o entro 5 mesi dopo l'ultima dose di atezolizumab o entro 90 giorni dopo l'ultima dose di tiragolumab o per 6 mesi dopo l'ultima dose di carboplatino o etoposide.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tiragolumab + Atezolizumab + Carboplatino ed Etoposide
Il trattamento di induzione con tiragolumab più atezolizumab e CE sarà somministrato su un ciclo di 21 giorni per 4 cicli. Dopo la fase di induzione, i partecipanti continueranno la terapia di mantenimento con tiragolumab più atezolizumab per cicli di 21 giorni.
Droga: Tiragolumab
Tiragolumab a una dose fissa di 600 milligrammi (mg), somministrato per infusione endovenosa (IV), ogni 3 settimane (Q3W) il giorno 1 di ogni ciclo di 21 giorni.
Altri nomi:
  • MTIG7192A
Droga: Atezolizumab
Atezolizumab a una dose fissa di 1200 mg, somministrato per infusione endovenosa, Q3W il giorno 1 di ogni ciclo di 21 giorni.
Altri nomi:
  • Tecentriq
Droga: Carboplatino
Carboplatino somministrato EV per raggiungere un'area target iniziale sotto la curva concentrazione-tempo (AUC) di 5 mg/mL/min, Q3W il giorno 1 di ciascun ciclo di 21 giorni per 4 cicli.
Droga: Etoposide
Etoposide 100 mg/m^2, somministrato per infusione endovenosa, ogni 3 settimane nei giorni 1, 2 e 3 di ciascun ciclo di 21 giorni per 4 cicli.
Comparatore placebo: Placebo + Atezolizumab + Carboplatino ed Etoposide
Il trattamento di induzione con placebo più atezolizumab e CE sarà somministrato su un ciclo di 21 giorni per 4 cicli. Dopo la fase di induzione, i partecipanti continueranno la terapia di mantenimento con placebo più atezolizumab per cicli di 21 giorni
Droga: Atezolizumab
Atezolizumab a una dose fissa di 1200 mg, somministrato per infusione endovenosa, Q3W il giorno 1 di ogni ciclo di 21 giorni.
Altri nomi:
  • Tecentriq
Droga: Carboplatino
Carboplatino somministrato EV per raggiungere un'area target iniziale sotto la curva concentrazione-tempo (AUC) di 5 mg/mL/min, Q3W il giorno 1 di ciascun ciclo di 21 giorni per 4 cicli.
Droga: Etoposide
Etoposide 100 mg/m^2, somministrato per infusione endovenosa, ogni 3 settimane nei giorni 1, 2 e 3 di ciascun ciclo di 21 giorni per 4 cicli.
Droga: Tiragolumab Matching Placebo
Placebo corrispondente, somministrato per infusione endovenosa, Q3W il giorno 1 di ogni ciclo di 21 giorni.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Investigator-assessed PFS in the FAS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Investigatori

  • Direttore dello studio: Clinical Trials, Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 dicembre 2020

Completamento primario (Effettivo)

31 agosto 2023

Completamento dello studio (Effettivo)

17 novembre 2025

Date di iscrizione allo studio

Primo inviato

7 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

7 dicembre 2020

Primo Inserito (Effettivo)

14 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • YO42373

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati dei singoli pazienti attraverso la piattaforma di richiesta dei dati degli studi clinici (www.vivli.org). Ulteriori dettagli sui criteri di Roche per gli studi ammissibili sono disponibili qui (https://vivli.org/ourmember/roche/). Per ulteriori dettagli sulla politica globale di Roche sulla condivisione delle informazioni cliniche e su come richiedere l'accesso ai documenti relativi agli studi clinici, vedere qui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi