2024-518812-38-00招募中2 期
Phase II clinical trial with an adaptive design according to response to cemiplimab monotherapy using ctDNA and subsequent treatment with chemotherapy (CT) and cemiplimab or cemiplimab monotherapy in first line advanced NSCLC patients. PALACE GECP 22/01
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 18
- 主要终点
- OS at 24 months in the intention to treat (ITT) population
研究概览
简要总结
The primary research goal is to determine whether therapy decision making based on ctDNA analysis improves OS. In this way, we will test whether the addition of chemotherapy in patients receiving Cemiplimab, based on the ctDNA levels after two cycles of Cemiplimab, improves OS at 24 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy
- •Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
- •Patients must be accessible for treatment and follow-up
- •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 3 days before enrolment
- •All sexually active men and women of childbearing potential must use a highly effective contraceptive method (<1% failure rate) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs
- •ECOG performance status 0-1
- •Patients aged ≥ 18 years
- •Prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy occurred at least 6 months prior to enrolment
- •Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment
- •Presence of at least one measurable lesion by computed tomography (CT-scan) per response evaluation criteria in solid tumors (RECIST) version 1.1
- •Anticipated life expectancy >12 weeks
- •Correct hematological, hepatic and renal function
排除标准
- •Patients whose tumors harbor an activating mutation in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy
- •Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy
- •Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
- •Has known allergy or hypersensitivity to components of study drug
- •Significant comorbidities that preclude the administration of chemotherapy according to the investigator’s criteria
- •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment
- •Untreated brain metastasis(es) that may be considered active. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period)and there is no evidence of new or enlarging brain metastases and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of REGN2810cemiplimab
- •Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810cemiplimab. Note in clarification: Patients who require brief courses of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded
- •Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency
- •History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to inclusion
- •History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments
- •Patients with grade ≥2 neuropathy
- •Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor)
- •Receipt of live vaccines (including attenuated) within 30 days of first study treatment
- •Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment prior to the start of the first treatment, during the study, and for at least 6 months after the last dose
- •Pregnant or breastfeeding women
- •Patients with a weight loss >10% within the previous 3 months
- •Patients with carcinomatous meningitis
- •Patients with a history of other malignant diseases within the past 3 years, with the exception of the following: - properly treated non-melanotic skin cancer - cancer in situ treated with curative intent - nonmuscularis propia invasive carcinoma of the bladder - or other malignancies treated with curative intent and without signs of disease for a period of > 3 years after the end of the treatment and which, in the opinion of the physician in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease
- •Patients must have recovered from a major surgery at least 14 days prior to enrolment
- •Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
- •Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria
结局指标
主要结局
OS at 24 months in the intention to treat (ITT) population
OS at 24 months in the intention to treat (ITT) population
次要结局
- 1. Duration of response (DOR)
- 2. Overall survival (OS) at 12, 36 and 48 months
- 3. Progression free survival (PFS) at 12, 24, 36 and 48 months
- 4. Sites of first failure
- 5. Overall response rate (ORR)
- 6. Toxicity profile
研究者
Mariano Provencio
Scientific
Fundacion GECP
研究点 (18)
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