metastatic non-small-cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10062042 Term: Lung neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
FONDAZIONE RICERCA TRASLAZIONALE (FORT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess 1-year survival rate in patients treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C) in subjects with advanced NSCLC progressing on first-line chemoimmunotherapy.;Secondary Objective: •To assess Overall Survival (OS) •To assess Progression-free survival (PFS) •To assess Objective Response Rate (ORR) •To assess treatment safety Exploratory •To assess correlation of ORR, PFS and OS with biomarkers in tumor tissue or blood.;Primary end point(s): •1-year Survival Rate;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall Survival (OS) (1 and 2-year OS) • Progression-free survival (PFS) (1 and 2-year PFS) • Objective Response rate (ORR) • Safety Exploratory • Correlation of ORR, PFS and OS with tumor biomarkers;Timepoint(s) of evaluation of this end point: 1 and 2 years 1 and 2 years Every 8 weeks Every 3 weeks Exploratory: 48 months | — |
Countries
France, Italy, Spain
Contacts
Public ContactClinical Operations & Regulatory Af
Clinical Research Technology
Outcome results
None listed