EUCTR2020-000035-50-HU进行中（未招募）1 期
Randomized, open-label, Phase 2 study of SAR408701 combined with pembrolizumab and pembrolizumab alone in patients with CEACAM5 and PD-L1 positive advanced/metastatic non-squamous non–small-cell lung cancer (NSQ NSCLC) - CARMEN-LC05
Sanofi aventis recherche & développement0 个研究点目标入组 65 人开始时间: 2020年4月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
- •- No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
- •- Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC assay of =2+ in intensity involving at least 50% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
- •- PD-L1 positive tumor (TPS =1%) as determined locally by an approved test
- •- Measurable disease based on RECIST 1.1.
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •- Capable of giving signed informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Medical condition reauiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or astrong CTP3A inhibitor.
- •- Untreated brain metastases and history of leptomeningeal disease.
- •- Significant concomitant illness, including any severe medical condition that, in the opinion of the investigator or Sponsor, would impair the patient’s participation in the study or interpretation of the results.
- •- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- •- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
- •- History of active autoimmune disease that has required systemic treatment in the past 2 years.
- •- History of allogeneic tissue/solid organ transplantation.
- •- Active infection requiring IV systemic therapy within 2 weeks prior to randomization or active tuberculosis.
- •- Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
- •- Non-resolution of any prior treatment-related toxicity to = Grade 2 according to NCI CTCAE V5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
- •- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted.
- •- Symptomatic herpes zoster within 3 months prior to screening.
- •- Significant allergies to humanized monoclonal antibodies.
- •- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- •- Concurrent treatment with any other anticancer therapy.
- •- Have received prior chemotherapy treatment for advanced/metastatic NSCLC.
- •- The patient is a candidate for a curative treatment with either surgical resection and/or chemoradiation
- •- Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is longer, for any investigational treatment).
- •- Any prior therapy targeting CEACAM5.
- •- Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4.
- •- Any prior maytansinoid treatment (DM1 or DM4 ADC).
- •- Is receiving systemic steroid therapy =3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication. Daily steroid replacement therapy or any corticosteroid premedication if applicable are allowed.
- •- Any radiation therapy to lung >30 Gy within 6 months of first study intervention administration.
- •- Has received or will receive a live vaccine within 30 days prior to the first study intervention administration.
- •- Any major surgery within the preceding 3 weeks of the first study intervention administration.
- •Prior/concurrent clinical study experience
- •- Current participation in any other clinical study involving an investigational study trea
研究者
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