CTIS2024-513731-24-00
Active, Not Recruiting
Phase 1
A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemo-therapy alone for the treatment of locally advanced and potentially resectable non-small cell lung cancer (NSCLC) patients_NADIM II
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-small cell lung cancer (NSCLC)
- Sponsor
- Fundacion GECP
- Enrollment
- 90
- Status
- Active, Not Recruiting
- Last Updated
- last year
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 International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients’ stage IIIB with T3N2 disease according to 8th edition can be included, 10\. Measurable or evaluable disease (according to RECIST 1\.1 criteria), 2\. Tumor should be considered resectable before study entry by a multidisciplinary team, 3\. ECOG (Performance status) 0\-1, 4\. Correct hematological, hepatic and renal function, 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, 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 during the study treatment and for a period of at least 12 months following the last administration of trial drugs, 9\. Patient capable of proper therapeutic compliance and accessible for correct follow\-up
Exclusion Criteria
- •1\. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene, 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, 2\. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included, 3\. Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement 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., 5\. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer 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 investigator would not permit the patient to complete the study or understand the patient 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 hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Outcomes
Primary Outcomes
Not specified
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