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临床试验/EUCTR2021-004280-27-DE
EUCTR2021-004280-27-DE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

Gilead Sciences, Inc.0 个研究点目标入组 224 人开始时间: 2022年2月16日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
224
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

入排标准

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.
  • •2) Life expectancy = 3 months.
  • •3) 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.
  • •4) 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.
  • •5) 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.
  • •6) ECOG performance status score of 0 or 1 assessed within 7 days prior to treatment.
  • •7) 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).
  • •8) Adequate hepatic function (bilirubin = 1.5 ? ULN, AST and ALT = 2.5 ? ULN or = 5 ULN if known liver metastases, and serum albumin > 3 g/dL).
  • •9) Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation {Cockcroft 1976}. For patients assigned to cohorts with cisplatin, creatinine clearance must be at least 60 mL/min.
  • •10) 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 co

排除标准

  • •1) Mixed SCLC and NSCLC histology.
  • •2) Active second malignancy.
  • •3) NSCLC that is eligible for definitive local therapy alone.
  • •4) 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.
  • •5) 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.
  • •6) Has had an allogenic tissue/solid organ transplant.
  • •7) Has severe (= Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient.
  • •8) Requirement for ongoing therapy with or prior use of any prohibited medications listed in (Section 5.7).
  • •9) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related AEs (irAE).
  • •10) Has received radiation therapy to the lung that is > 30 Gy within 6 months of the first treatment cycle.
  • •11) 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.
  • •12) 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.
  • •13) 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.
  • •14) 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.
  • •15) Known active CNS metastases and/or carcinomatous meningitis.
  • •16) Active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
  • •17) Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • •18) Active serious infection requiring antibiotics.
  • •19) Patients positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or multicentric Castleman disease.
  • •20) 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.
  • •21) Positive hepatitis C antibody and detectable hepatitis C virus (HCV) viral load.

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