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    Summary
    EudraCT Number:2021-001713-37
    Sponsor's Protocol Code Number:CONDOR
    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:2021-10-18
    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 number2021-001713-37
    A.3Full title of the trial
    Phase II, two-cohorts, randomized trial comparing standard of care versus immune-based combination in relapsed stage III non-small-cell lung cancer (NSCLC) pretreated with chemoradiotherapy and durvalumab
    Studio di fase 2 con due coorti, randomizzato, di confronto tra terapia standard e combinazioni di chemioimmunoterapia in pazienti con carcinoma polmonare non a piccole cellule recidivato dopo chemioradioterapia e durvalumab per malattia al terzo stadio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, two-cohorts, randomized trial comparing standard of care versus immune-based combination in relapsed stage III non-small-cell lung cancer (NSCLC) pretreated with chemoradiotherapy and durvalumab
    Studio di fase 2 con due coorti, randomizzato, di confronto tra terapia standard e combinazioni di chemioimmunoterapia in pazienti con carcinoma polmonare non a piccole cellule recidivato dopo chemioradioterapia e durvalumab per malattia al terzo stadio
    A.3.2Name or abbreviated title of the trial where available
    CONDOR
    CONDOR
    A.4.1Sponsor's protocol code numberCONDOR
    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 SponsorFONDAZIONE RICERCA TRASLAZIONALE (FORT)
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support(1) AstraZeneca S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Nicola Amore, 10
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80138
    B.5.3.4CountryItaly
    B.5.4Telephone number08119572570
    B.5.5Fax number0897724155
    B.5.6E-mailcondor@cr-technology.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 nameOlaparib
    D.3.2Product code [D0810000000]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeOlaparib
    D.3.9.3Other descriptive nameOlaparib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeOlaparib
    D.3.9.3Other descriptive nameOlaparib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 nameDurvalumab
    D.3.2Product code [MEDI4736]
    D.3.4Pharmaceutical form Powder for 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.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeDurvalumab
    D.3.9.3Other descriptive nameDurvalumab
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 (NSCLC)
    carcinoma polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    non-small-cell lung cancer (NSCLC)
    carcinoma polmonare non a piccole cellule
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The co-primary objectives of the study are as follows: 1) to investigate whether durvalumab prolongs survival when added to single agent chemotherapy (arm A) versus single agent chemotherapy (arm B) in patients progressing during durvalumab given as maintenance therapy in stage III disease; 2) whether, after chemoimmunotherapy, the addition of olaparib to durvalumab (arm C) improves survival over durvalumab (arm D) in patients relapsing after completing durvalumab maintenance therapy for stage III disease.
    Gli obiettivi co-primari sono i seguenti: 1) indagare se durvalumab prolunghi la sopravvivenza quando è aggiunto alla chemioterapia a singolo agente (Braccio A) rispetto alla sola chemioterapia a singolo agente (Braccio B) nei pazienti che progrediscono durante durvalumab somministrato come terapia di mantenimento nella malattia in stadio III; 2) se, dopo la chemioimmunoterapia, l'aggiunta di olaparib a durvalumab (Braccio C) migliori la sopravvivenza rispetto al solo durvalumab (Braccio D) nei pazienti con recidiva, dopo aver completato la terapia di mantenimento con durvalumab per la malattia in stadio III.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:

    1. Body weight >30kg
    2. Recurrent or metastatic NSCLC relapsed during or after completion of chemoradiotherapy with curative intent and maintenance durvalumab for stage III disease. Patients are eligible if they receive at least two cycles of platinum based chemotherapy or radical radiotherapy
    3. Tumor tissue available for biomarker testing.
    4. Evidence of disease progression during durvalumab maintenance or at the end of planned treatment. Patients who have interrupted planned durvalumab treatment after at least 6 months for reasons other than toxicity or progression (e.g. patient’s choice, logistic reasons, intercurrent acute illnesses) are eligible. Patients progressing during the first three months of Durvalumab are not eligible
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    6. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
    7. Age >18 years at time of study entry
    8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.


    9. Life expectancy of at least 16 weeks
    10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below::

    ¿ Haemoglobin =10.0 g/dL with no blood transfusion in the past 28 days
    ¿ Absolute neutrophil count (ANC) =1.5 × 109 /L
    ¿ Platelet count =100 × 109/L
    ¿ Serum bilirubin =1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.

    ¿ AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN

    ¿ creatinine clearance estimated of =51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test:

    Males:
    Creatinine CL (mL/min) = Weight (kg) x (140 – Age)
    72 x serum creatinine (mg/dL)

    Females:
    Creatinine CL (mL/min) = Weight (kg) x (140 – Age) x 0.85 72 x serum creatinine (mg/dL)
    11. Female patients should be using adequate contraceptive measures (highly effective method of contraception are present in table 3 of protocol “Highly Effective Methods of Contraception (<1% Failure Rate)”), should not be breastfeeding, from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy) or for at least 1 month after last dose of olaparib, or they must totally/truly abstain from any form of sexual intercourse. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.
    12. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
    13. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of Olaparib.
    1. Peso corporeo >30kg
    2. NSCLC ricorrente o metastatico, recidivato durante o dopo il completamento della chemioradioterapia con intento curativo e in mantenimento con durvalumab per la malattia in stadio III. I pazienti sono eleggibili se ricevono almeno due cicli di chemioterapia a base di platino o di radioterapia radicale
    3. Disponibilità del tessuto tumorale per l’analisi dei biomarcatori.
    4. Evidenza della progressione di malattia durante il mantenimento con durvalumab o alla fine del trattamento programmato. Sono eleggibili i pazienti che hanno interrotto il trattamento programmato con durvalumab dopo almeno 6 mesi per motivi diversi dalla tossicità o dalla progressione (ad es. scelta del paziente, ragioni logistiche, malattie acute intercorrenti). I pazienti che progrediscono durante i primi tre mesi di Durvalumab non sono eleggibili.
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0 oppure 1.
    6. Il paziente è disposto a/è in grado di rispettare il protocollo per la durata dello studio, compreso il periodo di trattamento e le visite e gli esami programmati, incluso il follow-up.
    7. Età >18 anni al momento dell’ingresso nello studio.
    8. Capacità di fornire il consenso informato scritto il che include l’adesione ai requisiti e alle restrizioni elencate nel modulo di consenso informato (ICF) e nel protocollo. Il consenso informato scritto e qualsiasi autorizzazione richiesta a livello locale devono essere ottenuti dal paziente/legale rappresentante prima di eseguire qualsiasi procedura relativa al protocollo, comprese le valutazioni di screening.
    9. Aspettativa di vita di almeno 16 settimane.
    10. I pazienti devono avere una normale funzionalità d’organo e del midollo osseo valutata entro 28 giorni a partire dalla somministrazione del trattamento in studio
    11. Le pazienti di sesso femminile devono utilizzare adeguate misure di contraccezione non devono allattare, dal momento dello screening per tutta la durata del trattamento in studio e per un periodo di washout del farmaco (90 giorni dopo l'ultima dose di durvalumab in monoterapia) o per almeno 1 mese dopo l'ultima dose di olaparib, oppure devono astenersi totalmente/realmente da qualsiasi forma di rapporto sessuale. Si definiscono donne in età potenzialmente fertile coloro che non sono chirurgicamente sterili
    12. Postmenopausa o evidenza di una condizione di non fertilità per le donne in età potenzialmente fertile: test di gravidanza negativo su urine o siero entro 28 giorni dal trattamento in studio e conferma del test prima del trattamento al giorno 1.
    13. I pazienti di sesso maschile devono utilizzare il preservativo durante il trattamento e per 3 mesi dopo l'ultima dose di olaparib quando hanno rapporti sessuali con una donna incinta o con una donna in età potenzialmente fertile. Anche le partner di sesso femminile di pazienti di sesso maschile dovrebbero utilizzare una forma di contraccezione altamente efficace se sono in età potenzialmente fertile. I pazienti di sesso maschile non devono donare lo sperma durante il periodo di assunzione di olaparib e per 3 mesi dopo l'ultima dose di olaparib.
    E.4Principal exclusion criteria
    1. No evidence of disease progression
    2. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
    3. Patients not pretreated with durvalumab with curative intent
    4. Patients treated with non-radical radiotherapy or with non conventional radiotherapy
    5. More than 4 cycles of platinum-based chemotherapy
    6. Rapid progressors. Progressors within first 3 month of treatment will be excluded from this trial
    7. Any clinical reason that makes the patient ineligible to receive any investigator’s choice single-agent chemotherapy regimen (for patients enrolled in cohorts A and B)
    8. Any clinical reason that makes the patient ineligible to receive any investigator’s choice platinum-based doublet chemotherapy regimen (for patients enrolled in cohorts C and D)
    9. Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
    10. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
    11. Disease progression within the first three months of Durvalumab therapy
    12. Tumor tissue not available
    13. Evidence of EGFR mutations or ALK or ROS1 rearrangements
    14. Performance status >1 (ECOG)
    15. Brain metastases are allowed if asymptomatic and pretreated.
    16. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (
    17. Patient with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to enrolment..
    18. Leptomeningeal disease.
    19. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (, or patients with congenital long QT syndrome.
    20. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
    21. Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent, grade 1 endometrial carcinoma)
    22. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins and patient with a known hypersensitivity to olaparib or any of the excipient of the product.
    23. Known hypersensitivity or allergy to any component of the Durvalumab formulation
    24. History of autoimmune disease
    25. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
    26. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    27. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    28. Positive test for HIV
    29. Patients with active hepatitis B or hepatitis C.
    30. Active tuberculosis
    31. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors . The required washout period prior to starting study treatment is 2 weeks.
    32. Concomitant use of known strong or moderate CYP3A inducers .
    33. Major surgery within 2 weeks of starting study treatment
    34. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
    35. Pregnancy or breast feeding women
    1. Nessuna evidenza di progression di malattia.
    2. Pazienti che ricevono qualsiasi chemioterapia o radioterapia sistemica (eccetto per motivi palliativi) entro 3 settimane prima del trattamento in studio.
    3. Pazienti non trattati precedentemente con durvalumab con intento curativo.
    4. Pazienti trattati con radioterapia non radicale o con radioterapia non convenzionale.
    5. Più di 4 cicli di chemioterapia a base di platino.
    6. Progressori rapidi.
    7. Qualsiasi ragione clinica che renda il paziente non idoneo a ricevere il regime chemioterapico a scelta dello sperimentatore in monoterapia
    8. Qualsiasi motivo clinico che renda il paziente non idoneo a ricevere il regime chemioterapico a base di doppio platino scelto dallo sperimentatore
    9. Tossicità persistenti causate da una precedente terapia antitumorale, con esclusione dell’alopecia.
    10. Pazienti con sindrome mielodisplastica/leucemia mieloide acuta o con caratteristiche suggestive di MDS/LMA.
    11. Progressione della malattia entro i primi tre mesi dalla terapia con Durvalumab.
    12. Tessuto tumorale non disponibile.
    13. Evidenza di mutazioni di EGFR o riarrangiamenti di ALK o di ROS1.
    14. Performance status >1 (ECOG).
    15. Le metastasi cerebrali sono consentite se asintomatiche e pretrattate.
    16. Diagnosi di un’altro tumore negli ultimi 3 anni, ad eccezione del carcinoma in situ della cervice, del carcinoma alla mammella e del carcinoma alla vescica o del carcinoma cutaneo
    17. Paziente con compressione del midollo spinale a meno che non abbia ricevuto un trattamento definitivo per questa condizione e ci sia evidenza di malattia clinicamente stabile per 28 giorni prima dell'arruolamento.
    18. Malattia leptomeningea.
    19. ECG a riposo che indica condizioni cardiache non controllate e potenzialmente reversibili, secondo quanto giudicato dallo sperimentatore o pazienti con sindrome del QT congenita.
    20. Versamento pleurico incontrollato, versamento pericardico o ascite che richiedono procedure di drenaggio ricorrenti. Sono ammessi pazienti con cateteri a permanenza
    21. Tumori maligni diversi dal NSCLC nei 5 anni precedenti l'arruolamento
    22. Anamnesi di gravi reazioni allergiche, anafilattiche o altre reazioni di ipersensibilità ad anticorpi chimerici o umanizzati o a proteine di fusione e pazienti con ipersensibilità nota a olaparib o ad uno qualsiasi degli eccipienti del prodotto.
    23. Nota ipersensibilità o allergia a qualsiasi componente della formulazione Durvalumab.
    24. Anamnesi di malattia autoimmune
    25. Pazienti considerati a scarso rischio medico a causa di un disturbo medico grave e non controllato, di una malattia sistemica non maligna o di un'infezione attiva e non controllata.
    26. Pazienti incapaci di deglutire farmaci somministrati per via orale e pazienti con disturbi gastrointestinali che possono interferire con l'assorbimento del farmaco in studio.
    27. Anamnesi di fibrosi polmonare idiopatica, polmonite in organizzazione (ad es. bronchiolite obliterante), polmonite indotta da farmaci, polmonite idiopatica o evidenza di polmonite attiva allo screening visualizzabile con TC del torace. È consentita l'anamnesi di polmonite da radiazioni nell’ambito delle radiazioni (fibrosi).
    28. Test positivo per l’HIV.
    29. Pazienti con epatite B attiva o con epatite C.
    30. Tuberculosi attiva.
    31. Uso concomitante di noti inibitori forti del CYP3A o di inibitori intermedi del CYP3A. Il periodo di washout richiesto prima dell'inizio del trattamento in studio è di 2 settimane.
    32. Uso concomitante di noti induttori fort o di induttori intermedi del CYP3A. Il periodo di washout richiesto prima dell'inizio del trattamento in studio è di 5 settimane per enzalutamide o fenobarbital e di 3 settimane per gli altri agenti.
    33. Intervento chirurgico maggiore entro 2 settimane dall'inizio del trattamento in studio;
    34. Precedente trapianto allogenico di midollo osseo o doppio trapianto di sangue da cordone ombelicale
    35. gravidanza o allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    Overall survival (OS) in arm A versus B and in arm C versus D
    Endpoint Primario:
    Sopravvivenza globale (OS) nel braccio A rispetto al braccio B e nel braccio C rispetto al braccio D.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Secondary Endpoint(s):
    The secondary endpoints are as follows:
    • Progression-free survival (PFS) in arm A versus B and in arm C versus D;
    • objective response rate (ORR) in arm A versus B and in arm C versus D;
    • safety and incidence of AEs in each arm according to treatment;
    • PFS and overall survival (OS) according to biomarkers (i.e., PD-L1, ERCC1, SLFN11, STK11, KEAP1, p53 expression, DNA repair genes [including BRCA 1-2 mutations] and tumor mutational burden).
    Endpoint(s) Secondari:
    Gli endpoints secondari sono i seguenti:
    • sopravvivenza libera da progressione (PFS) nel braccio A rispetto al braccio B e nel braccio C rispetto al braccio D;
    • tasso di risposta oggettiva (ORR) nel braccio A rispetto al braccio B e nel braccio C rispetto al braccio D;
    • sicurezza ed incidenza degli Eventi Avversi in ogni braccio in base al trattamento somministrato;
    • PFS e sopravvivenza globale (OS) in base ai biomarcatori (cioè, in base all’espressione di PD-L1, ERCC1, SLFN11, STK11, KEAP1, p53, ai geni di riparazione del DNA [comprese le mutazioni BRCA 1-2] e al carico mutazionale del tumore).
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial4
    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 concerned29
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    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 years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state176
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 176
    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)
    If a patient discontinues treatment prior to radiologic progression, then the patient
    should still continue to be followed until confirmed objective disease progression.
    Following confirmed progression, patients should continue to be followed up for survival
    SAEs must be collected and reported during the study and for up to 100 days after the
    last dose of study medication
    Se un paziente interrompe il trattamento prima della progressione radiologica, allora il
    paziente deve continuare ad essere seguito fino alla conferma della progressione
    obiettiva della malattia.
    Dopo la progressione confermata, i pazienti devono continuare a essere seguiti per la
    sopravvivenza ogni 2 mesi
    I SAE devono essere raccolti e riportati durante lo studio e fino a 100 giorni dopo
    l'ultima dose del farmaco in studio
    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 Decision2021-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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