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    Summary
    EudraCT Number:2020-002853-11
    Sponsor's Protocol Code Number:GO42501
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002853-11
    A.3Full title of the trial
    A PHASE II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF NEOADJUVANT AND ADJUVANT TIRAGOLUMAB PLUS ATEZOLIZUMAB, WITH OR WITHOUT PLATINUM-BASED CHEMOTHERAPY, IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED RESECTABLE STAGE II, IIIA, OR SELECT IIIB NON-SMALL CELL LUNG CANCER.
    STUDIO MULTICENTRICO, DI FASE II, IN APERTO, PER LA VALUTAZIONE DELLA SICUREZZA E DELL'EFFICACIA DI TIRAGOLUMAB PIÙ ATEZOLIZUMAB NEOADIUVANTE E ADIUVANTE, CON O SENZA CHEMIOTERAPIA A BASE DI PLATINO, IN PAZIENTI AFFETTI DA CARCINOMA POLMONARE NON A PICCOLE CELLULE NON TRATTATO IN PRECEDENZA, RESECABILE, LOCALMENTE AVANZATO, IN STADIO II, IIIA O CASI SELEZIONATI IN STADIO IIIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, with or Without Platinum-Based Chemotherapy, in Patients with Previously Untreated Locally Advanced Resectable Stage II, IIIa, or Select IIIb Non-Small Cell Lung Cancer.
    STUDIO PER LA VALUTAZIONE DELLA SICUREZZA E DELL'EFFICACIA DI TIRAGOLUMAB PIÙ ATEZOLIZUMAB NEOADIUVANTE E ADIUVANTE, CON O SENZA CHEMIOTERAPIA A BASE DI PLATINO, IN PAZIENTI AFFETTI DA CARCINOMA POLMONARE NON A PICCOLE CELLULE NON TRATTATO IN PRECEDENZA, RESECABILE, LOCALMENTE AVANZATO, IN STADIO II, IIIA O CASI SELEZIONATI IN STADIO IIIB
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberGO42501
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04832854
    A.5.4Other Identifiers
    Name:EU Trial NumberNumber:2022-502978-17-00
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nametiragolumab
    D.3.2Product code [RO7092284/F03-01]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTiragolumab
    D.3.9.1CAS number 1918185-84-8
    D.3.9.2Current sponsor codeRO7092284
    D.3.9.4EV Substance CodeSUB197861
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH/EU/1/17/1220/001
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.2Product code [RO5541267]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Anti-PDL1, Anti-PD-L1, aPDL1, PRO#303280
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Small Cell Lung Cancer.
    CARCINOMA POLMONARE NON A PICCOLE CELLULE
    E.1.1.1Medical condition in easily understood language
    Lung cancer that has spread to areas near the lungs or other organs and has not yet been treated by chemotherapy.
    carcinoma polmonare non a piccole cellule (NSCLC) non trattato in precedenza, localmente avanzato.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the safety of Atezo + Tira as neoadjuvant treatment followed by either Atezo + Tira or Chemo as adjuvant treatment;
    • To evaluate the safety of Atezo + Tira + Chemo as neoadjuvant treatment followed by Atezo + Tira as adjuvant treatment;
    • To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as neoadjuvant treatment based on major pathological response (MPR) rate.
    •Valutare la sicurezza di atezo + tira come trattamento neoadiuvante seguito da atezo + tira o chemio come trattamento adiuvante
    • Valutare la sicurezza di atezo + tira+ chemio come trattamento neoadiuvante seguito da atezo + tira come trattamento adiuvante
    •Valutare l'efficacia di atezo + tira o atezo + tira+ chemio come trattamento neoadiuvante
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of Atezo + Tira or Atezo + Tira + Chemo as neoadjuvant treatment based on pathological complete response (pCR);
    • To evaluate the efficacy of Atezo + Tira as neoadjuvant treatment followed by either Atezo + Tira or Chemo as adjuvant treatment based on event free survival (EFS);
    • To evaluate the efficacy of Atezo + Tira + Chemo as neoadjuvant treatment followed by Atezo + Tira as adjuvant treatment based on EFS;
    • To characterize the PK profile of atezolizumab and tiragolumab when given in combination;
    • To evaluate the immune response to atezolizumab and tiragolumab.
    •Valutare l'efficacia di atezo + tira o atezo + tira+ chemio come trattamento neoadiuvante
    •Valutare l'efficacia di atezo + tira come trattamento neoadiuvante seguito da atezo + tira o chemioterapia come trattamento adiuvante
    • Valutare l'efficacia di atezo + tira+ chemio come trattamento neoadiuvante seguito da atezo + tira come trattamento adiuvante
    •Valutare la sicurezza di atezo + tira come terapia neoadiuvante e adiuvante, con o senza chemioterapia, dal punto di vista del paziente
    •Valutare l'efficacia di atezo + tira o atezo + tira+ chemio come trattamento neoadiuvante
    •Caratterizzare il profilo PK di atezolizumab e tiragolumab quando somministrati in associazione
    •Valutare la risposta immunitaria ad atezolizumab e tiragolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology;
    • Eligible for R0 resection with curative intent at the time of screening, as confirmed by the operating attending surgeon and involved medical oncologist prior to study enrollment;
    • Adequate pulmonary function to be eligible for surgical resection;
    • Measurable disease, as assessed by the investigator per RECIST v1.1;
    • Adequate tumor tissue for PD-L1 assessment;
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
    • Adequate hematologic and end-organ function;
    • Negative HIV test at screening;
    • Negative for active hepatitis B and hepatitis C at screening.
    - NSCLC confermato istologicamente e citologicamente, in stadio II, IIIA o casi selezionati in stadio IIIB (solo T3N2), con istologia squamosa o non squamosa
    - Idonei alla resezione R0 con intento curativo alla data dello screening, come confermato dal chirurgo operante e dall'oncologo medico curante prima dell'arruolamento nello studio
    -Funzionalità polmonare adeguata per l'idoneità alla resezione chirurgica con intento curativo
    -Performance status secondo lo Eastern Cooperative Oncology Group di 0 o 1
    - Adeguata funzionalità ematologica e d'organo finale
    -Malattia misurabile, come valutato dallo sperimentatore in base ai criteri RECIST v1.1
    -Disponibilità di un campione di tumore rappresentativo, idoneo alla determinazione dello stato di PD-L1
    - Test HIV negativo allo screening
    -Test per epatite B e epatite C attiva negativo allo screening
    E.4Principal exclusion criteria
    • NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified;
    • Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC;
    • Any prior therapy for lung cancer;
    • Active or history of autoimmune disease or immune deficiency;
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis;
    • NSCLC with an activating EGFR mutation or ALK fusion oncogene;
    • Known c-ros oncogene 1 (ROS1) rearrangement;
    • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death;
    • Severe infection within 4 weeks prior to initiation of study treatment;
    • Treatment with investigational therapy within 42 days prior to initiation of study treatment;
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies;
    • Pregnant or lactating women.
    -NSCLC con istologia di carcinoma neuroendocrino a grandi cellule, carcinoma sarcomatoide o NSCLC non altrimenti specificato
    - Istologia di carcinoma polmonare a piccole cellule (small cell lung cancer, SCLC) o NSCLC con qualsiasi componente di SCLC
    -Qualsiasi terapia precedente per il carcinoma polmonare
    -Anamnesi o presenza in atto di malattia autoimmune o deficit immunitario
    - Positività anamnestica per fibrosi polmonare idiopatica, polmonite organizzativa,polmonite indotta da farmaco, polmonite idiopatica oppure evidenza di polmonite attiva
    - NSCLC con mutazione EGFR attivante o oncogene di fusione ALK
    - Riarrangiamento ROS1 noto
    - Anamnesi di neoplasia maligna diversa da NSCLC nei 5 anni precedenti allo screening, fatta eccezione per le neoplasie maligne con un rischio trascurabile di metastasi o decesso
    - Infezione grave nelle 4 settimane precedenti all'inizio del trattamento dello studio
    - Somministrazione di una terapia sperimentale nei 42 giorni precedenti all'inizio del trattamento dello studio
    - Trattamento precedente con agonisti di CD137 o terapie che bloccano i punti di controllo immunitari, inclusi gli anticorpi terapeutici anti-CTLA-4, anti-PD-1, anti¿TIGIT e anti-PD-L1
    - Gravidanza o allattamento al seno
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and length of surgical delays, incidence of operative and post-operative complications, and/or number of surgical cancellations related to study treatment;
    2. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0. The severity of cytokine release syndrome will be determined according to the ASTCT CRS Consensus Grading Scale;
    3. MPR, defined as =10% residual viable tumor at the time of surgical resection, as assessed by the central pathology laboratory.
    1. Incidenza e durata dei ritardi dell'intervento chirurgico, incidenza di complicazioni operatorie e post-operatorie e/o numero di annullamenti dell'intervento chirurgico correlati al trattamento dello studio
    2.Incidenza e gravità degli eventi avversi, con la gravità determinata secondo i criteri NCI CTCAE v5.0
    La gravità della CRS sarà determinata in base alla scala di classificazione consensuale ASTCT CRS.
    3. Tasso di MPR, definito come percentuale di pazienti che raggiungono la MPR, con MPR definita come < o = 10% di tumore vitale residuo alla data della resezione chirurgica nel tumore primitivo, in base alla valutazione del laboratorio centrale di patologia
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3; up to 6 years.
    1-3 Fino a 6 anni
    E.5.2Secondary end point(s)
    1. pCR, defined as the absence of any viable tumor cells in both the primary tumor and all sampled lymph nodes at the time of surgical resection, as assessed by the central pathology laboratory;
    2. EFS, defined as the time from first dose of study drug to any of the following events, whichever occurs first: disease progression that precludes surgical resection, as assessed by the investigator according to RECIST v1.1; or local or distant disease recurrence after surgery, including the occurrence of a new primary NSCLC; or death from any cause;
    3. Serum concentrations of atezolizumab and tiragolumab at specified timepoints;
    4. Prevalence of ADAs to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study;
    5. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study.
    1. pCR, definita come assenza di cellule tumorali vitali sia nel tumore primitivo sia in tutti i linfonodi prelevati alla data della resezione chirurgica, in base alla valutazione del laboratorio centrale di patologia
    2. EFS, definita come il tempo trascorso tra la prima dose di farmaco dello studio e uno qualsiasi dei seguenti eventi, a seconda di quale si verifichi per primo: progressione della malattia che impedisce la resezione chirurgica, in base alla valutazione dello sperimentatore secondo i criteri RECIST v1.1 oppure recidiva della malattia locale o a distanza dopo l'intervento chirurgico, inclusa la comparsa di un nuovo NSCLC primitivo, o morte dovuta a qualsiasi causa
    3. Concentrazioni sieriche di atezolizumab e tiragolumab in momenti temporali specificati
    4. Prevalenza di ADA anti-tiragolumab al basale e incidenza di ADA anti-tiragolumab durante lo studio
    5. Prevalenza di ADA anti-atezolizumab al basale e incidenza di ADA anti-atezolizumab durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Within 30 days after Pre- Surgery Visit;
    2. Up to 6 years;
    3-5. Day 1 Cycle 1, 2, 3, 4, 5, 8, 12, 16, at treatment discontinuation visit.
    1.Entro 30 giorni dopo la Pre- Surgery Visit;
    2. Fino a 6 anni;
    3-5. Giorno 1 Ciclo 1, 2, 3, 4, 5, 8, 12, 16, e alla treatment discontinuation visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    Immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Korea, Republic of
    United States
    Poland
    Netherlands
    Spain
    Switzerland
    Italy
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 82
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Currently, the Sponsor does not have any plans to provide Roche IMPs (atezolizumab and tiragolumab) or any other study treatments to patients who have completed the study. The Sponsor may evaluate whether to continue providing atezolizumab and tiragolumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf.
    Attualmente lo Sponsor non prevede piani per la fornitura degli IMP atezolizumab e tiragolumab o altri trattamenti di studio ai pazienti che hanno completato lo studio. Lo Sponsor può valutare se continuare a fornire atezolizumab e tiragolumab in accordo con le Policy Globali Roche all'accesso continuato all'IMP., disponibili al seguente sito web:http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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