2024-513731-24-00招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 23
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-inmunotherapy versus chemotherapy alone.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •Measurable or evaluable disease (according to RECIST 1.1 criteria)
- •Tumor should be considered resectable before study entry by a multidisciplinary team
- •ECOG (Performance status) 0-1
- •Correct hematological, hepatic and renal function
- •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
- •Patients aged > 18 years
- •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
- •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
- •Patient capable of proper therapeutic compliance and accessible for correct follow-up
排除标准
- •All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene
- •Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Patients with history of allergy to study drug components excipients
- •Women who are pregnant or in the period of breastfeeding
- •Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
- •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
- •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
- •Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4) and/or poor lung function.
- •Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer therapy
- •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.
- •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
- •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
- •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
结局指标
主要结局
Pathological Complete Response (pCR)
Pathological Complete Response (pCR)
次要结局
- 1. Overall survival
- 2.Progression-free survival
- 3. Major pathological response rate
- 4. Downstaging
- 5. Portion of delayed/canceled surgeries, length of hospital stays, surgical approach, incidence of AE/SAE related to surgery
- 6. Mortality at 90 days after surgery
- 7. Safety and tolerability: Adverse events graded according to CTCAE v5.0
- 8. Biomarker endpoints
- 9. To determine the association between MPR and histology
- 10. To determine the association of the histology with the progression free survival at 18 months
研究者
Mariano Provencio
Scientific
Fundacion GECP
研究点 (23)
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