Phase II clinical trial of Neo-adjuvant chemo/immunotherapy followed by adjuvant treatment depending on the resection status for the treatment of NSCLC patients diagnosed with pancoast tumor. A multicenter exploratory study_DUMAS

Fundacion GECP0 sites40 target enrollmentMarch 13, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundacion GECP
Enrollment: 40
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fundacion GECP

Eligibility Criteria

Inclusion Criteria

•1\. Previously untreated patients with histologically or cytologicallydocumented NSCLC diagnosed with Pancoast tumor according to 8th edition of the TNM (stages IIB, IIIA and T3N2 (IIIB) patients), 10\. 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, 11\. 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 enrollment., 12\. All sexually active men and women of childbearing potential must use an effective contracep\-tive 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 following the last administration of trial drugs, 13\. Patient capable of proper therapeutic compliance and accessible for correct follow\-up., 2\. PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days \+10 before enrollment) to rule out the presence of distant disease. Also, a brain CT\-SCAN or brain MRI will be done at baseline, 3\. Positive mediastinal lymph nodes by PET\-CT must be confirmed histologically. Mediastinal involvement may be considered without the need for histological confirmation when there is a mass of lymph nodes in which the margins cannot be distinguished, 4\. Measurable or evaluable disease (according to RECIST 1\.1 criteria), 5\. ECOG (Performance status) 0\-2, 6\. Patients with a life expectancy of at least more than 12 weeks, 7\. Patients aged \> 18 years and \= 75 years, 8\. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to enrollment i. Neutrophils \= 1500×109/L ii. Platelets \= 100 ×109/L iii. Hemoglobin \> 10\.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 \= 2\.5 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, 9\. Correct lung function without bronchodilators, defined by forced expiratory volume in 1 second (FEV1\) \>40% of the predicted normal volume, and a pulmonary diffusing capacity for carbon monoxide (DLCO) \>40% of the predicted normal value

Exclusion Criteria

•1\. Patients that receive previous treatment with antineoplastic drugs, chest radiotherapy, or previous surgery for lung cancer or for another reason, 10\. Patients with uncontrolled comorbidities that may affect the clinical trial compliance, 11\. 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 5 years prior to study entry AND no additional therapy is required during the study period., 12\. Any medical, mental, neurological or psychological condition which in the opinion of the in\-vestigator would not permit the patient to complete the study or understand the patient information sheet., 13\. Patients in any psychological, familiar, sociological or geographical situation that may hinder compliance with the study protocol and/or the follow up, 14\. Patients who have had prior treatment with an anti\-PD\-1, anti\-PDL1, anti\-PD\-L2, anti\-CTLA\-4 antibody, or any other antibody or drug specifically targeting T\-cell costimulation or immune checkpoint pathways, 15\. 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, 16\. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), 17\. Patients with know hypersensitivity to drugs with a structure similar to the study drug and/or history of allergy to study drug components excipients, 18\. Women who are pregnant or in the period of breastfeeding, 19\. Sexually active men and women of childbearing potential who are not willing to use an ef\-fective contraceptive method during the study, 2\. Pleural or pericardial effusion: Both will be considered indicative of metastatic disease unless proven otherwise. Those that, even being cytologically negative for malignancy, are exudates, will also be excluded. Patients with pleural effusion not visible on chest X\-ray or too small to perform diagnostic puncture safely may be included., 3\. Patients with a weight loss \>10% in the 3 months prior to the study entry, 4\. All patients carrying activating mutations in the TK domain of EGFR or any variety of altera\-tions in the ALK gene or ROS1 mutations., 5\. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hor\-mone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included., 6\. Patients with symptomatic neuropathy \> grade 1 according to the CTCAE v5\.0 and that were not related to the tumor, 7\. 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 replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease., 8\. 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.case of doubt please contact trial team., 9\. Patients with other active malignancy requiring concurrent intervention and/or concurrent tre