TREASURE- Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study - TREASURE

Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest0 sites104 target enrollmentMarch 30, 2020

DrugsTecentriq® 1.200 mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Enrollment: 104
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Eligibility Criteria

Inclusion Criteria

•1\.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.
•2\.Age \= 18 years.
•3\.Histologically or cytologically confirmed ED SCLC as defined according to the Veterans Administration Lung Study Group staging system.
•4\.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.
•5\.ECOG performance\-status score of 0 or 1 at screening
•6\.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
•7\.Thoracic treatment volume considered treatable using acceptable radiation fields as judged by a radiation oncologist
•8\.28 ± 7 days between last administration of chemo\-immunotherapy (carboplatin, etoposide, atezolizumab) and randomization.
•9\.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.
•10\.No previous radiotherapy to thorax lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug

Exclusion Criteria

•1\.Previous treatment with CD137 agonists, immune\-checkpoint blockade therapies, anti\-PD\-1, or anti\-PD\-L1 therapeutic antibodies (with the exclusion of prior immunotherapy as defined in inclusion criterion 6\).
•2\.Prior therapy for limited\-stage SCLC with curative intent.
•3\.Prior radiotherapy of lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
•4\.Oxygen\-dependent medical condition.
•5\.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.
•6\.Criterion removed.
•7\.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.
•8\.Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
•9\.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.
•10\.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.