Spots Global Cancer Trial Database for NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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