Clinical trial • Phase II • Oncology
Bevacizumab for Advanced non-small cell lung cancer
Phase II trial of Bevacizumab for Advanced non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-09-2024
- First CTIS Authorization Date
- 26-11-2024
Trial design
Randomised, atezolizumab (tecentriq) versus atezolizumab (tecentriq) + bevacizumab (avastin); doses/schedule not specified in the record-controlled Phase II trial across 32 sites in Italy.
- Randomised
- Yes
- Comparator
- Atezolizumab (Tecentriq) versus Atezolizumab (Tecentriq) + Bevacizumab (Avastin); doses/schedule not specified in the record
- Target Sample Size
- 130
Eligibility
Recruits 130 Vulnerable population not selected. Written informed consent is required from participants; no assent or parental consent procedures for minors are described (trial enrolment restricted to adults)..
- Pregnancy Exclusion
- 8. Pregnancy or lactating women who are pregnant, lactating, or intending to become pregnant during the study.
- Vulnerable Population
- Vulnerable population not selected. Written informed consent is required from participants; no assent or parental consent procedures for minors are described (trial enrolment restricted to adults).
Inclusion criteria
- {"criterion_text":"- 1) Histologically confirmed diagnosis of stage IV non-squamous NSCLC with no evidence of EGFR sensitizing mutations or ALK or ROS1 rearrangements.\n- 2) Availability of tumor tissue.\n- 3) 3) Evidence of high levels of PD-L1 expression evaluated with immunohistochemistry (=50% by 22C3 or SP263 or TC/IC 3 scoring by SP 142) .\n- 4) No previous chemotherapy. Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy.\n- 5) ECOG performance status 0-1.\n- 6) Life expectancy > 3 months\n- 7) Age =18 years.\n- 8) Measurable disease, as defined by RECIST v1.1.\n- 9) Adequate hematologic and organ function, defined by the following laboratory results obtained within 28 days prior to randomization: o ANC = 1500 cells/µL without granulocyte colony-stimulating factor support o Platelet count = 100,000/µL without transfusion o Hemoglobin = 9.0 g/dL Patients may be transfused to meet this criterion o AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions: ¿ Patients with documented liver metastases: AST and/or ALT = 5 × ULN ¿ Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN. o Serum bilirubin = 1.25 × ULN o Patients with known Gilbert disease who have serum bilirubin level = 3 mg/dL may be enrolled o Calculated creatinine clearance (CRCL) = 45 mL/min or calculated CRCL must be = 60 mL/min\n- 10) Patient compliance to trial procedures.\n- 11) Written informed consent."}
Exclusion criteria
- {"criterion_text":"- 1. No tumor tissue available.\n- 2. PD-L1 expression < 50 % or PD-L1 expression unknown or not assessable\n- 3. Patient positive for EGFR mutations or ALK or ROS1 rearrangements.\n- 4. Patients with squamous histology or with specific contraindication to bevacizumab therapy.\n- 5. Previously treated with chemotherapy\n- 6. Concomitant radiotherapy or chemotherapy.\n- 7. Previous therapy with any checkpoint inhibitor.\n- 8. Pregnancy or lactating women who are pregnant, lactating, or intending to become pregnant during the study.\n- 9. Symptomatic brain metastases\n- 10. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression\n- 11. Leptomeningeal disease.\n- 12. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n- 13. Uncontrolled or symptomatic hypercalcemia\n- 14. Malignancies other than NSCLC within 5 years prior to randomization\n- 15. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n- 16. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells\n- 17. History of autoimmune disease\n- 18. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n- 19. Positive test for HIV\n- 20. Patients with active hepatitis B or hepatitis C.\n- 21. Active tuberculosis\n- 22. Severe infections within 4 weeks prior to randomization\n- 23. Significant cardiovascular disease\n- 24. Major surgical procedure other than for diagnosis within 28 days prior to randomization\n- 25. Prior allogeneic bone marrow transplantation or solid organ transplant\n- 26. Administration of a live, attenuated vaccine within 4 weeks before randomization\n- 27. metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease\n- 28. Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment\n- 29. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization\n- 30. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, antiPD-1, and anti-PD-L1 therapeutic antibodies\n- 31. Treatment with systemic immunostimulatory agents\n- 32. Treatment with systemic immunosuppressive medications\n- 33. Patients who have received acute, low-dose, systemic immunosuppressant medications\n- 34. The use of steroids are permitted only as inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiencyand corticosteroids for CT pre treatment.\n- 35. Inadequately controlled hypertension\n- 36. Prior history of hypertensive crisis or hypertensive encephalopathy\n- 37. Significant vascular disease\n- 38. History of hemoptysis (= one-half teaspoon of bright red blood per episode) within 1 month prior to randomization;\n- 39. Current or recent use of aspirin or treatment with dipyramidole, ticlopidine, clopidogrel, and clostazol\n- 40. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to randomization\n- 41. Prophylactic anticoagulation for the patency of venous access devices is allowed\n- 42. Prophylactic use of low-molecular-weight heparin\n- 43. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device,\n- 44. History of abdominal or tracheosphageal fistula or gastrointestinal perforation\n- 45. Serious, non-healing wound, active ulcer, or untreated bone fracture\n- 46. Proteinuria\n- 47. Known sensitivity to any component of bevacizumab E.5 - End Points"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS) in patients treated with atezolizumab alone versus atezolizumab-bevacizumab combination","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 70
- Consent Approach
- Written informed consent required from participants ("Written informed consent" listed in inclusion criteria). Subject information and informed consent form documents are provided (documents titled in the record). No assent or parental consent processes for minors are described; trial enrolment limited to adults.
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 130
Italy
- Earliest CTIS Part Ii Submission Date
- 18-09-2024
- Latest Decision Or Authorization Date
- 05-08-2025
- Processing Time Days
- 321
- Number Of Sites
- 32
- Number Of Participants
- 130
Sites
- Site Name
- Istituto Tumori Bari Giovanni Paolo II
- Department Name
- alugini@hsangiovanni.roma.it
- Principal Investigator Name
- Michele Montrone
- Principal Investigator Email
- galetta@oncologico.bari.it
- Contact Person Name
- Michele Montrone
- Contact Person Email
- galetta@oncologico.bari.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncoematologia
- Principal Investigator Name
- Stefano Tamberi
- Principal Investigator Email
- stefano.tamberi@auslromagna.it
- Contact Person Name
- Stefano Tamberi
- Contact Person Email
- stefano.tamberi@auslromagna.it
- Site Name
- La Maddalena S.p.A.
- Department Name
- UO Oncologia Medica
- Principal Investigator Name
- Vittorio Gebbia
- Principal Investigator Email
- vittorio.gebbia@gmail.com
- Contact Person Name
- Vittorio Gebbia
- Contact Person Email
- vittorio.gebbia@gmail.com
- Site Name
- Azienda Unita Sanitaria Locale Di Piacenza
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Elena Zaffignani
- Principal Investigator Email
- e.zaffignani@ausl.pc.it
- Contact Person Name
- Elena Zaffignani
- Contact Person Email
- e.zaffignani@ausl.pc.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Sud Est
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Silvia Catanese
- Principal Investigator Email
- carmelo.bengala@uslsudest.toscana.it
- Contact Person Name
- Silvia Catanese
- Contact Person Email
- carmelo.bengala@uslsudest.toscana.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOC Oncologia Medica 2
- Principal Investigator Name
- Federico Cappuzzo
- Principal Investigator Email
- federico.cappuzzo@ifo.gov.it
- Contact Person Name
- Federico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.gov.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- UO Oncologia Medica
- Principal Investigator Name
- Diego Cortinovis
- Principal Investigator Email
- d.cortinovis@asst-monza.it
- Contact Person Name
- Diego Cortinovis
- Contact Person Email
- d.cortinovis@asst-monza.it
- Site Name
- Azienda Socio Sanitaria Territoriale Dei Sette Laghi
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Francesco Grossi
- Principal Investigator Email
- alessandro.tuzi@asst-settelaghi.it
- Contact Person Name
- Francesco Grossi
- Contact Person Email
- alessandro.tuzi@asst-settelaghi.it
- Site Name
- Ospedale "A. Perrino"
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Saverio Cinieri
- Principal Investigator Email
- saverio.cinieri@me.com
- Contact Person Name
- Saverio Cinieri
- Contact Person Email
- saverio.cinieri@me.com
- Site Name
- IRCCS Ospedale Sacro Cuore Don Calabria
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Stefania Gori
- Principal Investigator Email
- stefania.gori@sacrocuore.it
- Contact Person Name
- Stefania Gori
- Contact Person Email
- stefania.gori@sacrocuore.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
- Department Name
- Oncologia medica
- Principal Investigator Name
- Rossana Berardi
- Principal Investigator Email
- r.berardi@univpm.it
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- r.berardi@univpm.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Petros Giovanis
- Principal Investigator Email
- petros.giovanis@aulss1.veneto.it
- Contact Person Name
- Petros Giovanis
- Contact Person Email
- petros.giovanis@aulss1.veneto.it
- Site Name
- Azienda Ospedaliera S Giovanni Addolorata
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Andrea Lugini
- Principal Investigator Email
- alugini@hsangiovanni.roma.it
- Contact Person Name
- Andrea Lugini
- Contact Person Email
- alugini@hsangiovanni.roma.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Oncologia
- Principal Investigator Name
- Sara Pilotto
- Principal Investigator Email
- sara.pilotto.85@gmail.com
- Contact Person Name
- Sara Pilotto
- Contact Person Email
- sara.pilotto.85@gmail.com
- Site Name
- Ospedale “Giuseppe Mazzini” - Teramo
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Katia Cannita
- Principal Investigator Email
- katia.cannita@aslteramo.it
- Contact Person Name
- Katia Cannita
- Contact Person Email
- katia.cannita@aslteramo.it
- Site Name
- Ospedale S G Moscati
- Department Name
- SC di Oncologia Medica
- Principal Investigator Name
- Salvatore Pisconti
- Principal Investigator Email
- salvatore.pisconti@asl.taranto.it
- Contact Person Name
- Salvatore Pisconti
- Contact Person Email
- salvatore.pisconti@asl.taranto.it
- Site Name
- Ospedale Generale Provinciale Di Macerata
- Department Name
- UOC Oncologia
- Principal Investigator Name
- Nicola Battelli
- Principal Investigator Email
- battellin@gmail.com
- Contact Person Name
- Nicola Battelli
- Contact Person Email
- battellin@gmail.com
- Site Name
- Azienda Sanitaria Locale Della Provincia Di Biella
- Department Name
- SC di Oncologia
- Principal Investigator Name
- Roberta Gauna
- Principal Investigator Email
- lisa.pietrogiovanna@aslbi.piemonte.it
- Contact Person Name
- Roberta Gauna
- Contact Person Email
- lisa.pietrogiovanna@aslbi.piemonte.it
- Site Name
- Alessandro Manzoni Hospital
- Department Name
- UOC Oncologia
- Principal Investigator Name
- Isabella Vittimberga
- Principal Investigator Email
- i.vittimberga@asst-lecco.it
- Contact Person Name
- Isabella Vittimberga
- Contact Person Email
- i.vittimberga@asst-lecco.it
- Site Name
- Azienda Sanitaria Provinciale di Siracusa
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Paolo Tralongo
- Principal Investigator Email
- paolo.tralongo@asp.sr.it
- Contact Person Name
- Paolo Tralongo
- Contact Person Email
- paolo.tralongo@asp.sr.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Hector Soto Parra
- Principal Investigator Email
- hsotoparra.ctu@gmail.com
- Contact Person Name
- Hector Soto Parra
- Contact Person Email
- hsotoparra.ctu@gmail.com
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- SSD Oncologia Toracica
- Principal Investigator Name
- Angelo Delmonte
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Azienda Sanitaria Locale Roma 4
- Department Name
- UOSD Oncologia
- Principal Investigator Name
- Mario Rosario D'Andrea
- Principal Investigator Email
- mariorosario.dandrea@aslroma4.it
- Contact Person Name
- Mario Rosario D'Andrea
- Contact Person Email
- mariorosario.dandrea@aslroma4.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Oncoematologia
- Principal Investigator Name
- Mario Roselli
- Principal Investigator Email
- mario.roselli@uniroma2.it
- Contact Person Name
- Mario Roselli
- Contact Person Email
- mario.roselli@uniroma2.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Francesca Zanelli
- Principal Investigator Email
- francesca.zanelli@ausl.re.it
- Contact Person Name
- Francesca Zanelli
- Contact Person Email
- francesca.zanelli@ausl.re.it
- Site Name
- Azienda Ospedaliera Dei Colli Ospedale Monaldi
- Department Name
- U.O.C. di Pneumologia ad indirizzo oncologico
- Principal Investigator Name
- Danilo Rocco
- Principal Investigator Email
- danilorocc@yahoo.it
- Contact Person Name
- Danilo Rocco
- Contact Person Email
- danilorocc@yahoo.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Oncologia
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Dipartimento di oncologia ed ematologia
- Principal Investigator Name
- Federica Bertolini
- Principal Investigator Email
- barbieri.fausto@policlinico.mo.it
- Contact Person Name
- Federica Bertolini
- Contact Person Email
- barbieri.fausto@policlinico.mo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Claudia Bareggi
- Principal Investigator Email
- francesco.grossi@policlinico.mi.it
- Contact Person Name
- Claudia Bareggi
- Contact Person Email
- francesco.grossi@policlinico.mi.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Oncologia
- Principal Investigator Name
- Serena Ricciardi
- Principal Investigator Email
- mrmiglio53@gmail.com
- Contact Person Name
- Serena Ricciardi
- Contact Person Email
- mrmiglio53@gmail.com
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Oncologia Medica per le malattie toraciche
- Principal Investigator Name
- Alessandro Morabito
- Principal Investigator Email
- a.morabito@istitutotumori.na.it
- Contact Person Name
- Alessandro Morabito
- Contact Person Email
- a.morabito@istitutotumori.na.it
- Site Name
- IRCCS CROB
- Department Name
- UO di Oncologia Medica
- Principal Investigator Name
- Vittoria Lapadula
- Principal Investigator Email
- michele.aieta@crob.it
- Contact Person Name
- Vittoria Lapadula
- Contact Person Email
- michele.aieta@crob.it
Sponsor
Primary sponsor
- Full Name
- Fondazione Ricerca Traslazionale
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- Avastin 25 mg/ml concentrate for solution for infusion.
- Active Substance
- Bevacizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation EU/1/04/300/001 (authorised)
- Maximum Dose
- 15 mg/Kg
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation EU/1/17/1220/001 (authorised)
- Maximum Dose
- 1200 mg
- Combination Treatment
- Yes
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