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Undersøgelse af Atezolizumab Plus Carboplatin og Etoposid med eller uden Tiragolumab hos deltagere med ubehandlet småcellet lungekræft i omfattende stadie (SKYSCRAPER-02C)

15. september 2026 opdateret af: Hoffmann-La Roche

Et fase III, randomiseret, dobbeltblindt, placebokontrolleret studie af Atezolizumab Plus Carboplatin og Etoposid med eller uden Tiragolumab hos patienter med ubehandlet omfattende småcellet lungekræft

Formålet med dette multicenterstudie i Kina er at evaluere sikkerheden og effektiviteten af ​​tiragolumab plus atezolizumab og carboplatin og etoposid (CE) sammenlignet med placebo plus atezolizumab og CE hos deltagere med ubehandlet omfattende småcellet lungekræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

123

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1
  • Histologisk eller cytologisk bekræftet småcellet lungekræft i omfattende stadie (ES-SCLC) ifølge det modificerede Veterans Administration Lung Study Group (VALG) stadiesystem
  • Ingen forudgående systemisk behandling for ES-SCLC
  • For deltagere, der tidligere har modtaget kemoradioterapi for SCLC i begrænset stadie, skal de have haft behandling med kurativ hensigt og et behandlingsfrit interval på mindst 6 måneder mellem den sidste dosis/cyklus af kemoterapi, thoraxstrålebehandling eller kemoradioterapi og diagnosen ES- SCLC
  • Målbare sygdomme som defineret af RECIST v1.1
  • Indsendelse af en præ-behandling tumorvævsprøve
  • Tilstrækkelig hæmatologisk funktion og endeorganfunktion
  • Deltagere, der ikke modtager terapeutisk antikoagulering med International Normalized Ratio (INR) og Activated Clotting Time (aPTT)
  • Deltagere, der modtager terapeutisk antikoagulering: stabilt antikoagulerende regime
  • Negativ Human Immundefekt Virus (HIV) test ved screening
  • Negativ hepatitis B overfladeantigen (HBsAg) test ved screening
  • Positiv hepatitis B overfladeantistof (HBsAb) test ved screening eller negativ HBsAb ved screening ledsaget af et af følgende: negativt totalt hepatitis B kerneantistof (HBcAb) og/eller positivt totalt HBcAb test efterfulgt af en negativ hepatitis B virus (HBV) DNA-test
  • Negativ hepatitis C-virus (HCV) antistoftest ved screening eller positiv HCV antistoftest efterfulgt af en negativ HCV RNA-test
  • Negativ Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test eller negativ EBV polymerase kædereaktion (PCR) test ved screening
  • For kvinder i den fødedygtige alder: aftale om at forblive afholdende (afstå fra heteroseksuelt samleje) eller bruge prævention og aftale om at afstå fra at donere æg
  • For mænd: aftale om at forblive afholdende (afstå fra heteroseksuelt samleje) eller bruge præventionsmetoder og aftale om at afstå fra at donere sæd.

Ekskluderingskriterier:

  • Symptomatiske eller aktivt fremadskridende metastaser i centralnervesystemet (CNS).
  • Rygmarvskompression
  • Leptomeningeal sygdom
  • Ukontrolleret pleural effusion, perikardiel effusion eller ascites
  • Ukontrolleret eller symptomatisk hypercalcæmi
  • Kendt klinisk signifikant leversygdom, herunder aktiv viral, alkoholisk eller anden hepatitis, skrumpelever og arvelig leversygdom eller aktuelt alkoholmisbrug
  • Andre maligniteter end SCLC inden for 5 år før randomisering
  • Aktiv eller historie med autoimmun sygdom eller immundefekter
  • Anamnese med idiopatisk lungefibrose, organiserende lungebetændelse, lægemiddelinduceret lungebetændelse eller idiopatisk lungebetændelse eller tegn på aktiv lungebetændelse ved screening af thorax computertomografi (CT) scanning
  • Kendt aktiv tuberkulose, Nuværende behandling med antiviral terapi for HBV eller HCV
  • Alvorlig kronisk eller aktiv infektion
  • Behandling med terapeutiske orale eller IV antibiotika
  • Betydelig hjerte-kar-sygdom
  • Større kirurgisk indgreb bortset fra diagnose
  • Forudgående allogen knoglemarvstransplantation eller solid organtransplantation
  • Enhver anden sygdom, metabolisk dysfunktion, fysisk undersøgelse eller klinisk laboratoriefund, der giver rimelig mistanke om en sygdom eller tilstand
  • Administration af en levende, svækket vaccine
  • Tidligere behandling med CD137 agonister, T-celle co-stimulerende eller immun checkpoint blokade behandlinger
  • Behandling med systemiske immunstimulerende midler
  • Behandling med systemisk immunsuppressiv medicin
  • Anamnese med alvorlige allergiske anafylaktiske reaktioner på kimære eller humaniserede antistoffer eller fusionsproteiner
  • Kendt overfølsomhed over for kinesisk hamster ovarie (CHO) celleprodukter eller over for enhver komponent i tiragolumab eller atezolizumab formuleringerne
  • Anamnese med allergiske reaktioner over for carboplatin eller etoposid
  • Graviditet eller amning eller intention om at blive gravid under undersøgelsesbehandling eller inden for 5 måneder efter den sidste dosis atezolizumab eller inden for 90 dage efter den sidste dosis af tiragolumab eller i 6 måneder efter den sidste dosis af carboplatin eller etoposid.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tiragolumab + Atezolizumab + Carboplatin og Etoposid
Induktionsbehandling med tiragolumab plus atezolizumab og CE vil blive administreret i en 21-dages cyklus i 4 cyklusser. Efter induktionsfasen vil deltagerne fortsætte vedligeholdelsesbehandlingen med tiragolumab plus atezolizumab i 21-dages cyklusser.
Medicin: Tiragolumab
Tiragolumab i en fast dosis på 600 milligram (mg), administreret ved intravenøs (IV) infusion, hver 3. uge (Q3W) på dag 1 i hver 21-dages cyklus.
Andre navne:
  • MTIG7192A
Medicin: Atezolizumab
Atezolizumab i en fast dosis på 1200 mg, administreret som IV-infusion, Q3W på dag 1 i hver 21-dages cyklus.
Andre navne:
  • Tecentriq
Medicin: Carboplatin
Carboplatin administreret IV for at opnå et initialt målområde under koncentrationstidskurven (AUC) på 5 mg/ml/min, Q3W på dag 1 af hver 21-dages cyklus i 4 cyklusser.
Medicin: Etoposid
Etoposid 100 mg/m^2, administreret ved IV-infusion, Q3W på dag 1, 2 og 3 i hver 21-dages cyklus i 4 cyklusser.
Placebo komparator: Placebo + Atezolizumab + Carboplatin og Etoposid
Induktionsbehandling med placebo plus atezolizumab og CE vil blive administreret i en 21-dages cyklus i 4 cyklusser. Efter induktionsfasen vil deltagerne fortsætte vedligeholdelsesbehandlingen med placebo plus atezolizumab i 21-dages cyklusser
Medicin: Atezolizumab
Atezolizumab i en fast dosis på 1200 mg, administreret som IV-infusion, Q3W på dag 1 i hver 21-dages cyklus.
Andre navne:
  • Tecentriq
Medicin: Carboplatin
Carboplatin administreret IV for at opnå et initialt målområde under koncentrationstidskurven (AUC) på 5 mg/ml/min, Q3W på dag 1 af hver 21-dages cyklus i 4 cyklusser.
Medicin: Etoposid
Etoposid 100 mg/m^2, administreret ved IV-infusion, Q3W på dag 1, 2 og 3 i hver 21-dages cyklus i 4 cyklusser.
Medicin: Tiragolumab Matching Placebo
Matchende placebo, administreret ved IV-infusion, Q3W på dag 1 i hver 21-dages cyklus.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator-assessed PFS in the FAS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. december 2020

Primær færdiggørelse (Faktiske)

31. august 2023

Studieafslutning (Faktiske)

17. november 2025

Datoer for studieregistrering

Først indsendt

7. december 2020

Først indsendt, der opfyldte QC-kriterier

7. december 2020

Først opslået (Faktiske)

14. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YO42373

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau via platformen for anmodninger om kliniske undersøgelsesdata (www.vivli.org). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/ourmember/roche/). For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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