NCT05236608

A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC

A Phase 1b/2 Study to Evaluate the Combination of Nivolumab (Anti PD1 Monoclonal Ab) With ADG106 (4-1-BB Agonist Monoclonal Ab) in Metastatic NSCLC After Progression With antiPD1 Therapy and Platinum-based Chemotherapy (ADIVO Lung Study)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB. The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.

Conditions

• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Administered together with ADG106 via intravenous infusion.
DRUG	ADG106	Administered as an intravenous infusion over 90 minutes.

Timeline

• Start date: 2021-11-12
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2022-02-11
• Last updated: 2022-03-25

Locations

2 sites across 1 country: Singapore