Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

NCT04462276 | Completed Phase 2 DMC

• 1 other identifier: TREASURE
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 20

Brief Summary

This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Patients with a response after induction therapy with carboplatin/etoposide and atezolizumab will be included into this study to subsequently receive atezolizumab maintenance therapy and will be randomized to receive TRT or not. This trial aims to i.) increase the efficacy of combined atezolizumab- and chemotherapy by adding radiotherapy and ii.) determine the safety and tolerability of the combination of chemotherapeutic, immunological and radiological treatment in the first-line setting of advanced SCLC, and iii.) to collect tumor tissue as well as blood and stool samples for separate biomarker research project.

Conditions

Small Cell Lung Cancer Extensive Stage; Thoracic Radiotherapy

Keywords

SCLC; thoracic radiotherapy; Atezolizumab

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  time from randomization to death

  at 24 month after lat patient randomized

Secondary Outcomes (10)

• 1-year Overall Survival (OS) rate

  at 1 year after randomization

• 2-year Overall Survival (OS) rate

  at 2 years after randomization

• Progression-free survival (PFS)

  at study end (approx. 2 years after last patient randomized)

• objective response rate (ORR)

  at study end (approx. 2 years after last patient randomized)

• Intrathoracic tumor control

  at study end (approx. 2 years after last patient randomized)

Other Outcomes (1)

• Collection of biomarker samples for separate biomarker research project

  at study end (approx. 2 years after last patient randomized)

Study Arms (2)

Arm A: Atezolizumab + thoracic radiotherapy

EXPERIMENTAL

Atezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W) Thoracic radiation therapy (TRT), 30 Gy in 10 fractions

Drug: Atezolizumab; Radiation: thoracic radiotherapy (TRT)

Arm B: Atezolizumab

EXPERIMENTAL

Atezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)

Arm A: Atezolizumab + thoracic radiotherapy; Arm B: Atezolizumab

thoracic radiotherapy (TRT) RADIATION

30 Gy in 10 fractions

Arm A: Atezolizumab + thoracic radiotherapy

Eligibility Criteria

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

You may qualify if:

• Fully-informed written consent and locally required authorization (European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Age ≥ 18 years.
• Histologically or cytologically confirmed ED SCLC as defined according to the Veterans Administration Lung Study Group staging system.
• Measurable ED SCLC according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. In cases of CR or PR without residual measurable disease after 4 cycles of induction therapy, patients may still be included. In such cases "No Evidence of Disease (NED)" should be reported in eCRF.
• ECOG performance status score of 0 or 1 at screening
• Any response after four cycles of standard chemo-immunotherapy (carboplatin, etoposide, atezolizumab) defined as CR/PR or thoracic SD with CR/PR of extrathoracic lesions as per RECIST 1.1
• Thoracic treatment volume considered treatable using acceptable radiation fields as judged by a radiation oncologist
• ± 7 days between last administration of chemo-immunotherapy (carboplatin, etoposide, atezolizumab) and randomization.
• Patients with a history of treated CNS metastases are eligible, if there is no ongoing requirement for corticosteroids as therapy for CNS disease. Before randomization, MRI of brain (with contrast, unless contraindicated) is recommended in subjects with suspected or known brain metastases, as per local standard., Patients with asymptomatic brain metastases that do not require local therapy with irradiation (whole brain irradiation) can be included. In ambiguous cases, consultation with the LKP or his/her delegate is advised.
• No previous radiotherapy to lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
• Availability of pre-treatment tumor tissue specimen
• 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.
• FEV1 ≥ 40% (%Soll)
• Adequate bone marrow and renal function including the following:
• Hemoglobin ≥ 9.0 g/dL;

You may not qualify if:

• Prior therapy for limited-stage SCLC with curative intent.
• Prior radiotherapy of lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
• Oxygen-dependent medical condition.
• History or current radiology suggestive of interstitial lung disease (ILD) (including but not limited to idiopathic pulmonary fibrosis (IPF)/usual interstitial pneumonia (UIP)/cryptogenic fibrosing alveolitis (CFA)), non-infectious pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis.
• Criterion removed.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
• Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
• 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.
• Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent is acceptable.
• 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
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician.

Sponsors & Collaborators

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

Study Sites (20)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Kepler Universitätsklinikum, MC III., Pneumologie

Linz, Austria

Location

DRK Kliniken Berlin-Mitte

Berlin, 13359, Germany

Location

Kliniken der Stadt Köln gGmbH Lungenklinik Köln-Merheim

Cologne, 51109, Germany

Location

Universitätsklinikum Carl-Gustav-Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Klinik Löwenstein gGmbH

Löwenstein, 74245, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München

München, 80336, Germany

Location

Klinikum Bogenhausen

München, 81925, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Münster, 48153, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, 63069, Germany

Location

Krankenhaus Barmherzige Brüder

Regensburg, 93049, Germany

Location

Vinzent von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, 70199, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

• Bozorgmehr F, Christopoulos P, Chung I, Cvetkovic J, Feisst M, Krisam J, Schneider MA, Heussel CP, Kreuter M, Muller DW, Thomas M, Rieken S. Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease - a randomized, open-label, multicenter phase II trial. BMC Cancer. 2022 Sep 24;22(1):1011. doi: 10.1186/s12885-022-10074-9.

  PMID: 36153496 DERIVED

MeSH Terms

Interventions

atezolizumab

Study Officials

• Farastuk Bozorgmehr, Dr. med.

  Thoraxklinik at Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized, open label, multicenter, phase II trial

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 8, 2020
• Study Start: July 28, 2020
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (18); AU (2)