Phase
Condition
N/ATreatment
Tedopi
Docetaxel
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female patients willing and able to give written informed consent;
- Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence ofEGFR mutations or ALK or ROS1 rearrangement;
- Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapyor 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LAregimen) and eligible for treatment with docetaxel. This criterion implies thatpatients with immunotherapy primary resistance are excluded;
- Patients must have experienced progressive disease (PD), either during or within 3months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring afterprevious clear benefit (any complete -CR- or partial response -PR), or after previousstable disease (SD);
- Performance status 0-1 (ECOG);
- Patient compliance to trial procedures;
- Age ≥ 18 years;
- Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl);
- Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN inpresent of liver metastases);
- Normal level of creatinine;
- Female patient: childbearing potential either terminated by surgery, radiation, ormenopause, 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 WOCBPmust use any contraceptive method with failure rate less than 1%/year and they shouldnot donate semen as follows: in arm A and C until 6 months since the last dose ofdocetaxel; in arm B until 3 months since last dose of tedopi.
- Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2weeks prior to treatment. Subjects with symptomatic tumor lesions that may requirepalliative radiotherapy within 4 weeks of first treatment are strongly encouraged toreceive palliative radiotherapy prior to treatment. Patients are eligible if CNSmetastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2weeks prior to randomization;
- Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.
Exclusion
Exclusion Criteria:
- Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;
- No previous chemoimmunotherapy for metastatic disease or evidence of diseaseprogression during the first 4 cycles of chemoimmunotherapy (primary resistance).Patients with adjuvant resistance (documented loco-regionally and/or systemic relapseof their disease occurring <6 months after the last dose of anti-PD-(L)1-basedsystemic adjuvant therapy) are excluded;
- Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;
- Symptomatic brain metastases. Asymptomatic brain metastases are allowed if notrequiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);
- Diagnosis of any other malignancy during the last 3 years, except for in situcarcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumorsconsidered cured;
- Pregnancy or lactating;
- Patients with an active, known or suspected autoimmune disease. Patients with type Idiabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditionsnot expected to recur in the absence of an external trigger are permitted to enroll;
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmunedisease;
- Patients should be excluded if they are positive test for hepatitis B virus surfaceantigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute orchronic infection;
- Patients should be excluded if they have known history of testing positive for humanimmunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Study Design
Connect with a study center
Institut Sainte Catherine
Avignon, 84918
FranceActive - Recruiting
Centre Hospitalier de Cholet
Cholet, 49300
FranceActive - Recruiting
GHR Mulhouse Sud Alsace - Hôpital Emile Muller
Mulhouse, 68100
FranceActive - Recruiting
Nouvel Hôpital Civil - Hopitaux Universitaires de Strasbourg
Strasbourg, 67091
FranceActive - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forlì 47014
ItalyActive - Recruiting
AO Busto Arstizio PO Saronno
Saronno, Varese
ItalySite Not Available
Ospedale Mater Salutis Legnago
Legnago, Verona 37045
ItalyActive - Recruiting
Ospedale Sacro Cuore Don Calabria
Negrar, Verona
ItalyActive - Recruiting
Ospedale San Paolo
Civitavecchia,
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Careggi
Firenze,
ItalyActive - Recruiting
AOOR Papardo-Piemonte
Messina,
ItalyActive - Recruiting
AOU "Maggiore della Carità"
Novara,
ItalyActive - Recruiting
Istituto Oncologico Veneto
Padova, 35128
ItalyActive - Recruiting
Azienda Ospedaliera di Perugia
Perugia,
ItalyActive - Recruiting
IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia,
ItalySite Not Available
Istituto Nazionale Tumori "Regina Elena"
Roma, 00144
ItalyActive - Recruiting
ASST Sette Laghi
Varese,
ItalySite Not Available
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, 15006
SpainActive - Recruiting
Clinica Mi Tres Torres - UOMI Cancer Center
Barcelona, 08017
SpainActive - Recruiting
Vall d'Hebron Universitary Hospital
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital de Mataró
Mataró, 08304
SpainActive - Recruiting
Hospital Universitario Regional de Málaga - Hospital Civil
Málaga, 29011
SpainActive - Recruiting
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