NCT05825625

NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing

Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing: a Non-randomized, Open-label, Single-arm Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, open-label, single-arm phase II trial to investigate the feasibility and efficacy of combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC patients.

Detailed description

The present study is a prospective, investigator-initiated, single-arm, open-label phase II trial. Patients with non-small cell lung cancer of clinical stage II, IIIA and IIIB (T3N2 only) will receive 2 cycles platinum-based standard of care chemotherapy in combination with anti-TIGIT antibody tiragolumab and the anti-PD-L1 antibody atezolizumab followed by curative intent surgery. After surgery, patients not achieving pCR will receive additional 2 cycles chemotherapy in combination with tiragolumab and atezolizumab, followed by tiragolumab/atezolizumab only for up to one year (max 16 cycles) or until intolerable toxicity, disease progression or patients' request, whatever occurs first. Patients with pCR will receive the IO-IO antibodies only (without additional chemotherapy). The objective of this study is to investigate the feasibility, efficacy and safety of combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC patients. Efficacy outcomes will be correlated to the accompanying in-depth translational analyses, which aim to understand the role of the tumor microenvironment in response to IO-IO therapies and to identify biomarkers that may be associated with response and resistance.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1,200 mg by IV infusion Q3W.
DRUG	Tiragolumab	Tiragolumab by IV infusion Q3W.

Timeline

• Start date: 2023-05-26
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-04-24
• Last updated: 2025-05-23

Locations

2 sites across 1 country: Germany