NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing

NCT05825625 | Active Not Recruiting Phase 2

• 3 other identifiers: NeoTRACKIKF-0562022-501322-38-00
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; NSCLC; neoadjuvant; surgery; perioperative; immunotherapy

Outcome Measures

Primary Outcomes (1)

• MPR rate after curative intent surgery

  number of patients with ≤ 10% of residual viable tumor in lung and lymph nodes as evaluated by pathology review, divided by the number of all patients with posttreatment tumor tissue available

  12 weeks

Secondary Outcomes (5)

• Pathological complete response (pCR)

  12 weeks

• Radiological response by RECIST v1.1 criteria

  12 weeks

• Event-free survival (EFS)

  78 months

• Overall survival (OS)

  78 months

• Rate of adverse events and serious adverse events rate

  78 months

Study Arms (1)

Platinum-based chemotherapy in combination with atezolizumab and tiragolumab

EXPERIMENTAL

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.

Drug: Atezolizumab; Drug: Tiragolumab

Interventions

Atezolizumab DRUG

Atezolizumab 1,200 mg by IV infusion Q3W.

Also known as: Tecentriq

Platinum-based chemotherapy in combination with atezolizumab and tiragolumab

Tiragolumab DRUG

Tiragolumab by IV infusion Q3W.

Also known as: no other name available

Platinum-based chemotherapy in combination with atezolizumab and tiragolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent
• Patient\* 18 years or older at time of signing informed consent form
• Histologically confirmed NSCLC of squamous or non-squamous histology
• Resectable clinical stage II, IIIA and IIIB (T3N2 only) NSCLC (according to UICC 8)
• Adequate disease staging by PET and/or CT as per SOC (performed ≤ 42 days prior initiation of the study treatment)
• At least 1 measurable lesion according to RECIST v1.1
• ECOG performance status ≤ 1
• Adequate lung and cardiac function for curative intend lung resection (R0) according to German S3 guideline
• Eligibility to receive a platinum-based neoadjuvant chemotherapy
• The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
• The patient is willing and able to provide liquid and tissue samples for the accompanying translation project.
• Adequate bone marrow and renal function including the following:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count ≥ 1.0 x 109/L
• Platelets ≥ 75 x 109/L

You may not qualify if:

• Treatment in any other clinical trial with an investigational product within 30 days before screening
• Clinical stage I, IIIB (T4N2), IIIC, nodal NSCLC stage cN3 and stage IV NSCLC
• Positive testing of activating (TKI-responsive) EGFR-mutation, ROS1-mutation or known ALK fusion oncogene
• Expected pneumonectomy at baseline to achieve curative intend resection
• Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g. hormone replacement therapy) is acceptable.
• History of allogeneic tissue / solid organ transplant or allogeneic stem cell transplantation
• History of active primary immunodeficiency.
• Clinical diagnosis of active tuberculosis.
• Positive testing for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV) RNA indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of atezolizumab/tiragolumab.
• Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis \[with the exception of diverticulosis\], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener's syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
• Patients with controlled Type I diabetes mellitus on an insulin regimen

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Thoraxklinik-Heidelberg gGmbH: collaborator
• Roche Pharma AG: collaborator

Study Sites (2)

Universitätsklinikum Essen (AöR)-Westdeutsches Tumorzentrum Essen

Essen, 45147, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

Related Publications (1)

• Roesch RM, Schnorbach J, Klotz LV, Griffo R, Thomas M, Stenzinger A, Christopoulos P, Allgaeuer M, Schneider M, Schuler M, Wiesweg M, Schramm A, Bolukbas S, Doerr F, Hegedus B, Cvetkovic J, Kirchner M, Eichhorn ME, Winter H, Bozorgmehr F, Eichhorn F. NeoTRACK trial: Neoadjuvant TiRagolumab, Atezolizumab and Chemotherapy - dissection of IO- efficacy in NSCLC by longitudinal tracKing - protocol of a non-randomised, open-label, single-arm, phase II study. BMJ Open. 2025 Mar 27;15(3):e096617. doi: 10.1136/bmjopen-2024-096617.

  PMID: 40147985 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Salah-Eddin Al-Batran, Prof. Dr.

  Institut für Klinische Krebsforschung IKF GmbH

  STUDY DIRECTOR

• Florian Eichhorn, Dr.

  Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-arm phase II trial combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: May 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)