EUCTR2018-004515-45-ES
Active, Not Recruiting
Phase 1
A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemotherapy alone for the treatment of locally advanced and potentially resectable non-small cell lung cancer (NSCLC) patients
Fundación GECP0 sites90 target enrollmentApril 11, 2019
Conditionson-small cell lung cancerMedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsOPDIVO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-small cell lung cancer
- Sponsor
- Fundación GECP
- Enrollment
- 90
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Previously untreated patients with histologically\- or cytologically\- documented NSCLC who present stage IIIA disease (according to 8th version of the Interna\-tional Association for the Study of Lung Cancer Staging Manual in Thoracic Oncol\-ogy) and also, potentially resectable locally advanced NSCLC patients’ stage IIIB with T3N2 disease according to 8th edition can be included.
- •\-PET/CT including IV contrast (CT of diagnostic quality) will be per\-formed at baseline
- •2\.Tumor should be considered resectable before study entry by a multidisciplinary team
- •3\.ECOG (Performance status) 0\-1
- •4\.Screening laboratory values must meet the following criteria and should be ob\-tained within 14 days prior to registration/inclusion
- •i.Neutrophils \= 1500×109/L
- •ii.Platelets \= 100 x×109/L
- •iii.Hemoglobin \> 9\.0 g/dL
- •iv.Serum creatinine \= 1\.5 x ULN or creatinine clearance (CrCl) \= 40 mL/min (if using the Cockcroft\-Gault formula below):
- •a.Female CrCl \= (140 \- age in years) x weight in kg x 0\.85/
Exclusion Criteria
- •1\.All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- •2\.Patients with active, known or suspected autoimmune disease. Subjects with viti\-ligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thy\-roiditis only requiring hormone replacement or unexpected conditions of recur\-rence in the absence of an external trigger are allowed to be included.
- •3\.Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replace\-ment steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •4\.Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3\-4\) and/or poor lung function. In case of doubt please contact trial team.
- •5\.Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti\-cancer therapy
- •6\.Patients with previous malignancies (except non\-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
- •7\.Any medical, mental or psychological condition which in the opinion of the inves\-tigator would not permit the patient to complete the study or understand the pa\-tient information
- •8\.Patients who have had prior treatment with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell costimulation or immune checkpoint pathways
- •9\.Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hep\-atitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- •10\.Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Outcomes
Primary Outcomes
Not specified
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