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OSE2101C301A: A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Locally Advanced (IIIB) Unsuitable for Radiotherapy or Metastatic (IV) Non-Small-Cell Lung Cancer (ATALANTE 1)

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

1. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
3. Female or male, 18 years of age or older.
4. Histologically or cytologically proven diagnosis of NSCLC that is locally advanced (stage IIIB) unsuitable for radiotherapy or metastatic (stage IV) according to the 7th edition of tumor, node, metastasis (TNM) in Lung Cancer published by the International Union Against Cancer and the American Joint Committee on Cancer.
5. Subjects with disease recurrence or progression After therapy with an immune checkpoint inhibitor and platinum-based chemotherapy i) either 1st line chemotherapy followed by 2nd line checkpoint inhibitor, or ii) 1st line combination of checkpoint inhibitor and chemotherapy
6. Subjects with measurable or non-measurable lesions.
7. Subjects must express HLA-A2 phenotype as assessed serologically.
8. Subjects must be considered suitable for chemotherapy with either single-agent pemetrexed or docetaxel.
9. Subjects with brain metastases are eligible if treated (whole brain radiotherapy, stereotaxic radiotherapy, surgery) and have no symptoms (except for signs and symptoms related to central nervous system therapy) for at least 2 weeks before initiation of allocated treatment and are not taking any forbidden medications.
10. Any prior chemotherapy, immunotherapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study medication.
11. Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia).
12. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
13. Adequate organ function as defined by all the following criteria:
    - Albuminemia > 25g/L
    - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to liver metastases
    - Total serum bilirubin ≤ 1.5 x ULN
    - Absolute neutrophil count (ANC) ≥ 1500/L
    - Platelets ≥ 100000/L
    - Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
    - Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min.

Criteri di esclusione: 


1. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). Large-cell carcinoma.
2. NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part of his prior chemotherapy.
3. Current or previous treatment with investigational therapy in another therapeutic clinical trial interrupted less than 4 weeks before study treatment initiation.
4. Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement.
5. Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study).
6. Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease
7. Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed and with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 80) as they could be randomly assigned to Arm B.
8. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
9. Treatment with corticosteroids in the last 3-week period before inclusion, except for topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption (e.g. with a dose ≤ 500 microgram beclomethasone equivalent for inhaled steroids), or adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent which are permitted.
10. A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection (and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies).
11. Patients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism.
12. Patients with interstitial lung disease.
13. Patients with active B or C hepatitis.
14. Other malignancy: patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer).
15. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
16. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment.
17. Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
18. Breastfeeding women.
19. Women with a positive pregnancy test.

Schema di trattamento: 

- OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every two months for the remainder of year one and finally every three months until unequivocal Recist 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. OSE2101 dose will be 5 mg of peptide (0.5 mg for each peptide).

 

- Patients receiving Docetaxel: Docetaxel 75 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of a 21-day cycle.
Patients receiving Pemetrexed: Pemetrexed, 500 mg/m2, will be administered by intravenous infusion over 10 minutes on Day 1 of a 21-day cycle.

Trattamento sperimentale: 

OSE2101

Trattamento di controllo: 

Docetaxel o Pemetrexed

Obiettivi primari dello studio: 

Overall Survival time (OS) [ Time Frame: Approx. 24 months ]

Obiettivi secondari dello studio: 

- Disease Control Rate (DCR) [ Time Frame: 6 months ]
- QLQ-C30 (EORTC QLQ questionnaire): 'Global health status/QoL' score based on questions 29 and 30 [ Time Frame: Approx. 24 months ]
- QLQ-LC13 (lung cancer module from EORTC QLQ questionnaire): time to 1st ≥ 10-point deterioration in chest pain, dyspnea or cough [ Time Frame: Approx. 24 months ]
- Progression Free Survival (PFS) [ Time Frame: Approx. 24 months ]
- Safety and tolerability profile compared to the control group [ Time Frame: Approx. 24 months ]

Centri partecipanti

Nord Italia

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Angelo Delmonte
Telefono: 0543739268

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr.ssa Laura Bonanno
Telefono: 0498215931
Email: oncologia2@iov.veneto.it

 

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA

Riferimento: Dr. Federico Cappuzzo
Telefono: 0544285206
Email: federico.cappuzzo@auslromagna.it

 

Ospedale “Infermi” Rimini
Via Settembrini 2 - 47923 Rimini - RN

Riferimento: Dr. Davide Tassinari
Email: datamanager.oncologiarimini@auslromagna.it

 

A.U.L.S.S. 21 Legnago
Via Gianella 1 - 37045 Legnago - VR

Riferimento: Dr. Andrea Bonetti
Telefono: 0442622801
Email: oncologia.medica.leg@aulss9.veneto.it

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

 

Centro Italia

Ospedale San Luca
Via Guglielmo Lippi Francesconi - 55100 Lucca - LU

Riferimento: Dr.ssa Editta Baldini
Telefono: 0583449545
Email: sperimentazione.oncologia@usl2.toscana.it

 

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG

Riferimento: Dr. Vincenzo Minotti

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

Riferimento: Dr.

 

Ospedale Nuovo regina Margherita
Via Morosini 30 - 00153 Roma - RM

Riferimento: Dr. Riccardo Samaritani

 

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI

Riferimento: Prof. Michele Maio
Telefono: 0577586326
Email: m.maio@ao-siena.toscana.it

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

Riferimento: Prof. Domenico Galetta
Telefono: 0805555442
Email: galetta@oncologico.bari.it

 

Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE

Riferimento: Dr. Giampiero Romano
Telefono: 0832661962
Email: lecce.oncologia@libero.it

 

Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2015-003183-36

Data di inserimento: 12.02.2019

Promotore

OSE Immunotherapeutics

CRO

ORION

Principal Investigator ITALIA

Presidio Ospedaliero Vito Fazzi / A.S.L. Lecce

Riferimento: Dr. Giampiero Romano

Telefono: 0832661962

Email: lecce.oncologia@libero.it

Localita: Lecce

 

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