Nivolumab/Ipilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome

Sponsor
Universita di Verona
Study ID
NCT05597800
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab and Ipilimumab — DRUG
    Nivolumab will be administered with ipilimumab, plus 2 cycles of histology-based platinum doublet chemotherapy: * Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 * Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m Dosing: nivolumab 360 mg every 3 weeks + ipilimumab 1 mg/kg every 6 weeks (up to maximum 2 years) + histology-based, platinum doublet chemotherapy (every 3 weeks for two cycles).

Study Details

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).

Key Dates

Start date
Feb 1, 2023
Status verified
Oct 2022
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: HBV and HCV patients
    Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections, such as HBV and HCV in cohort A. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.
  • Experimental: Cohort B: HIV patients
    Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as HIV in cohort B. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.
  • Experimental: Cohort C: Long COVID syndrome
    Participants (≥ 18 years) must have histologically confirmed metastatic or unresectable non-small cell lung cancer (both non-squamous and squamous), without sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations, with chronic viral infections such as Long Covid syndrome in Cohort C. Squamous histology: carboplatin AUC 6 + paclitaxel 200 mg/m2 Non-squamous histology: carboplatin AUC 5 or 6 + pemetrexed 500 mg/m2 or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2.

Primary Outcome Measure

Safety, defined as onset of grade 3 or 4 (G3/4) treatment-related adverse events (TRAEs), assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5. [ Time Frame: 3 years ]

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