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Clinical Trials/EUCTR2018-004515-45-ES
EUCTR2018-004515-45-ESActive, not recruitingPhase 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 enrollmentStarted: April 11, 2019Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
90
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

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/
  • •72 x serum creatinine in mg/dL
  • •b.Male CrCl = (140 - age in years) x weight in kg x 1.00/
  • •72 x serum creatinine in mg/dL
  • •v.AST/ALT = 3 x ULN
  • •vi.Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • •vii.The patients need to have a forced expiratory volume (FEV1) = 1.2 liters or >40% predicted value
  • •viii.INR/APTT within normal limits
  • •5.All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
  • •6.Patients aged > 18 years
  • •7.Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning of chemotherapy.
  • •8.All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months follow-ing the last administration of trial drugs
  • •9.Patient capable of proper therapeutic compliance and accessible for correct fol-low-up
  • •10.Measurable or evaluable disease (according to RECIST 1.1 criteria)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 90
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 90

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)
  • •11.Patients with history of allergy to study drug components excipients
  • •12.Women who are pregnant or in the period of breastfeeding
  • •13.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study

Investigators

Sponsor
Fundación GECP

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