CTIS2024-513225-23-00进行中（未招募）1 期
An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations - GS-US-576-6220
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 257
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients must meet all of the following inclusion criteria at screening/Day -1 to be eligible for participation in this study (no waivers for patient eligibility will be offered or permitted): 1) Female or male patients, 18 years of age or older, able to understand and give written informed consent., Patients with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: a) Patients on ART must have a CD4 + T-cell count > 350 cells/mm3 at time of screening. b) Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening. c) Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry. d) The combination ART regimen must not contain any medications that may interfere with SN-38 metabolism., Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.3., Life expectancy = 3 months., Patients with the following pathologically documented NSCLC that meets all of the following criteria: a) Has documented evidence of Stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition). b) Has documented negative test results for EGFR and ALK. c) Has no known genomic alterations in ROS1, NTRK, BRAF, RET mutations, or other actionable driver oncogenes with approved therapies for frontline treatment (actionable genomic alteration). (Testing is not required if status is unknown.). d) Have provided tumor tissue from locations not radiated prior to biopsy. Formalin fixed specimens after the patient has been diagnosed with metastatic disease will be preferred for evaluation of Trop-2 expression and determination of PD-L1 status prior to enrollment if not already performed by an approved 22C3 assay. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible. Bone biopsies and fine-needle aspirations are not suitable tissues. If no tissue is available, a new biopsy may be obtained prior to enrollment to the study., Measurable disease by CT or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria (see Appendix 11.6) by investigator. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator., No prior systemic treatment for mNSCLC. Patients 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 for a platinum agent., ECOG performance status score of 0 or 1 assessed within 7 days prior to treatment., Adequate hematologic counts without transfusional or growth factor support within 10 days of study drug initiation (hemoglobin = 9 g/dL, absolute neutrophil count [ANC] = 1500/mm3, and platelets = 100,000/µL)., Adequate hepatic function (bilirubin = 1.5 x ULN, AST and ALT = 2.5 x ULN or = 5 x ULN if known liver meta
排除标准
- •Mixed SCLC and NSCLC histology., Has received radiation therapy to the lung that is > 30 Gy within 6 months of the first treatment cycle., Patients may not have received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks, or stereotactic radiosurgery within 72 hours prior to enrolment., Have previously received treatment with any of the following: a) Topoisomerase 1 inhibitors. Any agent including an ADC containing a chemotherapeutic agent targeting topoisomerase 1. b) Trop-2-targeted therapy., Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment., Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy., Known active CNS metastases and/or carcinomatous meningitis., Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment., Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Active serious infection requiring antibiotics., Patients positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or multicentric Castleman disease., Active second malignancy., Active or chronic hepatitis B infection. Positive for hepatitis B surface antigen. Patients who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative PCR for confirmation of active disease., Positive hepatitis C antibody and detectable hepatitis C virus (HCV) viral load, Positive serum pregnancy test (Appendix 11.3) or women who are lactating., Other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations., Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted., NSCLC that is eligible for definitive local therapy alone., Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Intermittent use of topical, inhalational, intranasal, and intraocular steroids is permitted., Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed., Has had an allogenic tissue/solid organ transplant., Has severe (= Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient., Requirement for ongoing t
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Canceron-small-cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-004280-27-DEGilead Sciences, Inc.224
招募中
2 期
A Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non−Small-Cell Lung CancerNon-small cell lung cancer2024-513225-23-00Gilead Sciences Inc.156
进行中（未招募）
不适用
An open-label, multicenter phase II trial of Sunitinib for patients with chemo-refractory metastatic gastric cancerChemorefractory metastatic adenocarcinoma of stomach, esophagogastric junction and lower esophagus (Barrett carcinoma)MedDRA version: 8.1Level: LLTClassification code 10017758Term: Gastric cancerEUCTR2006-000476-33-DEJohannes-Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik50
进行中（未招募）
不适用
A study to observe the long-term safety of GS-9137 (which is one of a new class of antiretroviral medications called integrase inhibitors) given with ritonavir, in combination with other antiretroviral agents in subjects who have completed a prior GS-9137/ritonavir (GS-9137/r) study for the treatment of HIV-1 infection.Human Immunodeficiency Virus (HIV-1) InfectionMedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2007-004736-23-Outside-EU/EEAGilead Sciences Inc.1,000
进行中（未招募）
不适用
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Ageno medical, conditionhealthy, at risk volunteers will be recruited for a clinical trial to receive three vaccinations against meningococcal strain B and one vaccination against meningococcal strains A,C, W and Y.EUCTR2007-001563-29-DEovartis Vaccines and Diagnostics S.r.l.250