EUCTR2018-002607-34-IT
Active, not recruiting
Phase 1
Phase II, open-label study of atezolizumab in a CoHort of pretreated, Advanced Non-small cell lung cancer (NSCLC) patients with rare histologiCal subtypEs – CHANCE trial - CHANCE TRIA
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 sites43 target enrollmentJanuary 14, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
- Enrollment
- 43
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Locally advanced, relapsed or metastatic non\-small cell lung cancer – stage IIIB/IV.
- •Histologically confirmed diagnosis of non\-small cell lung cancer with rare histological subtype, according to World Health Organization (WHO) 2015 classification.
- •Histologic subtype variants to be enrolled into the study include: large cell neuroendocrine carcinoma (LCNEC);
- •Availability of tumor sample (material obtained from core\-biopsy or surgical specimen) for central pathology revision is mandatory.
- •Availability of a formalin\-fixed, paraffin\-embedded tumor block or 7\-10 unstained tumor slides suitable for PD\-L1 expression assessment is mandatory. The assessment of PD\-L1 expression will be performed by using both SP\-142 and SP\-263 antibody assays. The collection of tumor sample should be performed before patients are enrolled into the study .
- •Male and female and \= 18 years of age.
- •Life expectancy \= 12 weeks.
- •Progressive disease after or during at least one previous standard chemotherapy line.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, version 1\.1 (RECIST v1\.1\); clear radiological evidence of disease progression after previous treatment has to be documented.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2\.
Exclusion Criteria
- •Prior treatment with Atezolizumab or any other immunotherapy agents (anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CD137, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell costimulation or immune checkpoint pathways).
- •Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
- •Concurrent anticancer treatment, immune therapy, or cytokine therapy, except for erythropoietin.
- •Major surgery for any reason within 4 weeks (or 2 weeks for minor surgery) from registration and/or if the subject has not fully recovery from the surgery within 4 weeks of registration.
- •Subjects receiving immunosuppressive agents such as steroids for any reason should be tapered off these drugs before initiation of the trial treatment. Corticosteroid therapy with a dose \= 10 mg prednisone or equivalent will be allowed. Note:
- •o Subjects receiving bisphosphonates or denosumab are eligible provided treatment was initiated at least 14 days before first dose of trial treatment
- •o Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration of steroids will be completed in 14 days, or that the daily dose after 14 days will be \=10 mg per day of equivalent prednisone.
- •Persisting toxicity related to prior therapy of grade \>1 according to National Cancer Institute \- Common Terminology Criteria Adverse Event (NCI\-CTCAE) v. 4\.03\.
- •Known severe hypersensitivity reactions to chimeric or monoclonal antibodies, fusion proteins (grade \=3 NCI\-CTCAE v. 4\.03\).
- •Patients with untreated, symptomatic and/or progressive brain metastases, or with carcinomatous meningitis.
Outcomes
Primary Outcomes
Not specified
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