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Combi-TED - A Multicenter, Phase II, Open Label, Randomized Trial Evaluating the Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Seconda linea

Criteri di inclusione: 

1- Male and female patients willing and able to give written informed consent;
2- Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement;
3- Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded;
4- Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete -CR- or partial response -PR), or after previous stable disease (SD);
5- Performance status 0-1 (ECOG);
6- Patient compliance to trial procedures;
7- Age ≥ 18 years;
8- Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl);
9- Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN in present of liver metastases);
10- Normal level of creatinine;
11- Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device] until 5 months after end of treatment.
or Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi.
12- Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;
13- Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.

Criteri di esclusione: 

1- Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;
2- No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded;
3- Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;
4- Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);
5- Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured;
6- Pregnancy or lactating;
7- Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
8- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease;
9- Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection;
10- Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Trattamento sperimentale: 

Arm A - tedopi + docetaxel
Arm B - tedopi + nivolumab
Arm C - docetaxel

Trattamento di controllo: 

-

Obiettivi primari dello studio: 

  • 1-year Survival Rate [ Time Frame: 1 year ]

Centri partecipanti

Nord Italia

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

Riferimento: Dr. Angelo Delmonte
Telefono: 0543739100
Email: angelo.delmonte@irst.emr.it

 

A.O.U. Maggiore della Carità
Corso Mazzini 18 - 28100 Novara - NO

 

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

Riferimento: Dr.ssa Giulia Pasello
Telefono: 0498215931
Email: oncologia2@iov.veneto.it

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr.ssa Maria Pagano
Email: maria.pagano@ausl.re.it

 

ASST Valle Olona - P.O. Saronno
Piazzale Borella 1 - 21047 Saronno - VA
NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Claudio Verusio
Email: claudio.verusio@asst-valleolona.it

 

Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA
ASST dei Sette Laghi - NB: Arruolamento pazienti non ancora attivo

 

Ospedale Sacro Cuore Don Calabria
Via Via Don A. Sempreboni 5 - 37024 Negrar - VR

Riferimento: Dr.ssa Stefania Gori
Telefono: 0456013472
Email: stefania.gori@sacrocuore.it

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
NB: Arruolamento pazienti non ancora attivo

Riferimento: Dr.ssa Francesca Mazzoni
Telefono: 0557947298

 

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

Riferimento: Dr. Giulio Metro
Telefono: 0755783695
Email: giulio.metro@ospedale.perugia.it

 

Ospedale San Paolo - ASL Roma 4
Largo Donatori del Sangue 1 - 00053 Civitavecchia - RM
NB: Arruolamento pazienti non ancora attivo

 

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Prof. Federico Cappuzzo
Telefono: 0652665698
Email: federico.cappuzzo@ifo.it

 

Sud Italia e isole

AO Papardo
Contrada Papardo - 98158 Messina - ME
NB: Arruolamento pazienti non ancora attivo

Riferimento: Prof. Vincenzo Adamo
Telefono: 0903996150
Email: vadamo@unime.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT04884282

Data di inserimento: 17.04.2023

Promotore

Fondazione Ricerca Traslazionale

Principal Investigator ITALIA

Istituto Nazionale Tumori 'Regina Elena', Roma

Riferimento: Prof. Federico Cappuzzo

Telefono: 0652665698

Email: federico.cappuzzo@ifo.it

Localita: Roma

 

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