A Phase 2 non-randomized, open-label, multi-cohort, multi center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with lung cancer or pleural mesothelioma - .

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 360 人开始时间: 2021年8月30日最近更新: 2021年9月7日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 360

研究概览入排标准研究者记录与标识符相似试验

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

•- Participant must be >/=18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
•- Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (cohorts A1, A2, B1, B2), Stage IV non-squamous NSCLC (cohort A3), or unresectable malignant pleural mesothelioma (cohort C1).
•- Cohort A1: PD-L1 expression TPS >= 50%; Cohort A2: PD-L1 expression TPS 1 – 49%.
•- Prior anticancer therapy: * Cohorts A1, A2, A3: No prior systemic therapy for advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease. * Cohorts B1, B2: One prior anti-PD1/PD-L1 regimen (may include chemotherapy) plus one additional chemotherapy regimen * Cohort C1: One or two prior systemic treatments that include pemetrexed-based regimen in combination with platinum agent.
•- All cohorts must have a measurable disease.
•- Mandatory baseline biopsy for the first 20 participants to enroll in cohorts A1, A2.
•- Cohorts B1 and B2: Based on the Investigator's judgment, either docetaxel or pemetrexed is not the best treatment option for the participant.
•- Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: * to use approved contraception method and submit to regular pregnancy testing prior to treatment and for 180 days after discontinuing study treatment * to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.
•- Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
•- 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 216
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

排除标准

•- Eastern Cooperative Oncology Group (ECOG) performance status of >=2.
•- Poor bone marrow reserve.
•- Poor organ function.
•- Participants with baseline SpO2 - Active brain metastases or leptomeningeal disease.
•- History of allogenic or solid organ transplant.
•- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days.
•- Has received prior IL-2-based anticancer treatment.
•- Comorbidity requiring corticosteroid therapy.
•- Antibiotic use (excluding topical antibiotics) <=14 days prior to first dose of IMP.
•- Severe or unstable cardiac condition within 6 months prior to starting study treatment.
•- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years.
•- Known second malignancy either progressing or requiring active treatment within the last 3 years.
•- Cohorts A1, A2, A3, C1: Prior treatment with an agent (approved or investigational) that blocks the PD1/PD-L1 pathway (participants who joined a study with an anti-PD1/PD-L1 but have written confirmation they were on control arm are allowed).
•- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.

研究者

发起方

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

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