NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05825625
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1,200 mg by IV infusion Q3W.
  • Tiragolumab — DRUG
    Tiragolumab by IV infusion Q3W.

Study Details

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.

Key Dates

Start date
May 26, 2023
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Platinum-based chemotherapy in combination with atezolizumab and tiragolumab
    Patients will receive 2 cycles of SOC platinum-based chemotherapy as per investigator's choice in combination with atezolizumab and tiragolumab administrated by IV infusion. Curative intended surgery will follow after last dose of neoadjuvant treatment. After surgery, patients will receive adjuvant treatment including 2 cycles of platinum-based chemotherapy and atezolizumab plus tiragolumab for up to 1 year. Patients who achieved pCR will receive only atezolizumab plus tiragolumab for up to one year as maintenance therapy.

Primary Outcome Measure

MPR rate after curative intent surgery [ Time Frame: 12 weeks ]

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