drugset
drugset / Trial / NCT03520686

Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

NCT03520686 ↗

Phase 3 Terminated 102 enrolled ImmunityBio, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.

Timeline

Start
2018-05-18
Primary completion
2025-10-13
Completion
2025-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject N-803 Protein / enzyme biologic 15 ug/kg Subcutaneous
Subject N-803 Protein / enzyme biologic 1.2 mg Subcutaneous
Background Atezolizumab Monoclonal antibody 1200 mg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Background Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Background Nivolumab Monoclonal antibody 360 mg Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma