NCT03846310

A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).

Detailed description

In the dose-escalation phase, escalating doses of etrumadenant in combination with carboplatin and pemetrexed at standard doses (Arm A), and etrumadenant in combination with carboplatin, pemetrexed and pembrolizumab (Arm B), may be assessed in participants with advanced NSCLC. Eligible participants will receive oral administration of etrumadenant as well as IV infused carboplatin, pemetrexed, with or without pembrolizumab in this phase. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase. In the dose-expansion phase, zimberelimab in combination with carboplatin and pemetrexed (Arm 1), and etrumadenant at RDE in combination with carboplatin, pemetrexed, and zimberelimab (Arm 2) may be assessed in eligible NSCLC participants who harbor an EGFR mutation and have progressed on EGFR Tyrosine Kinase Inhibitor (TKI) treatment(s). Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.

Conditions

• Non Small Cell Lung Cancer Metastatic
• Non Small Cell Lung Cancer
• Nonsquamous Nonsmall Cell Neoplasm of Lung
• Sensitizing EGFR Gene Mutation

Interventions

Type	Name	Description
DRUG	Etrumadenant	Etrumadenant is an A2aR and A2bR antagonist
DRUG	Zimberelimab	Zimberelimab is a fully human anti-PD-1 monoclonal antibody
DRUG	Carboplatin	Carboplatin administered as part of standard chemotherapy regimen
DRUG	Pemetrexed	Pemetrexed administered as part of standard chemotherapy regimen
DRUG	Pembrolizumab	Pembrolizumab is a humanized anti-PD-1 monoclonal antibody

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2019-02-19
• Last updated: 2024-12-09

Locations

22 sites across 4 countries: United States, Singapore, South Korea, Taiwan

Regulatory

• FDA-regulated drug study