Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversita di Verona
About this trial
Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV/HCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).
Eligibility criteria
Qualifiers
Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC;
No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations;
Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer);
No prior systemic anticancer therapy;
Disqualifiers
Eastern Cooperative Oncology Group (ECOG) score ≥2;
Untreated symptomatic brain metastases or leptomeningeal metastases;
Another active concomitant malignancy;
Active, known or suspected, autoimmune disease;
Trial design
Treatments tested in this trial
- Nivolumab and Ipilimumab
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov