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临床试验/NL-OMON51766
NL-OMON51766招募中2 期

A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non Small Cell Lung Cancer - 213824 - Lung Platform

GlaxoSmithKline0 个研究点目标入组 20 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
入组人数
20
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

年龄范围
18 至 99（—）

入选标准

  • •Participants are eligible to be included in the study only if all of the
  • •following criteria apply.
  • •1. Is capable of giving signed informed consent as described in Section 11.6 of
  • •the protocol, which includes compliance with the requirements and restrictions
  • •listed in the ICF and in this protocol.
  • •2. Is, at the time of signing the ICF, at least 18 years old or the legal age
  • •of consent in the jurisdiction in which the study is taking place.
  • •3. Has a histologically or cytologically confirmed diagnosis of locally
  • •advanced unresectable NSCLC not eligible for curative surgery and/or definitive
  • •radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or
  • •nonsquamous). Mixed tumors will be categorized by the predominant cell type; if
  • •small-cell or neuroendocrine elements are present, the participant is
  • •ineligible.
  • •4. Has not received prior systemic therapy for their locally advanced or
  • •metastatic NSCLC.
  • •NOTE: Completion of treatment with cytotoxic chemotherapy and/or radiation as
  • •part of neoadjuvant/adjuvant therapy is allowed if therapy was completed at
  • •least 6 months prior to the diagnosis of locally advanced or metastatic
  • •disease. Prior treatment with neoadjuvant/adjuvant immunotherapy is not
  • •5. Provides a tumor tissue sample obtained at the time of or after the initial
  • •diagnosis of locally advanced or metastatic NSCLC. Although a fresh tumor
  • •tissue sample obtained during screening is preferred, an archival tumor
  • •specimen (collected within 2 years prior to screening*) is acceptable. Tumor
  • •tissue must be from a site not previously irradiated. Biopsies obtained prior
  • •to the administration of any systemic therapy administered for the treatment of
  • •a participant*s tumor (such as neoadjuvant/adjuvant therapy) are not
  • •acceptable. Needle or excisional biopsies or resected tissue is required.
  • •Cytological specimens such as fine needle aspirates, bone marrow samples, or
  • •cell blocks are not acceptable, nor are bone specimens.
  • •*NOTE: If multiple specimens are available, the most recent archival tumor
  • •specimen should be submitted.
  • •6. Has a PD-L1-high (TC/TPS *50%) tumor as determined by the DAKO 22C3 or
  • •VENTANA SP263 assay performed by a local laboratory or by the VENTANA SP263
  • •assay at a central laboratory.
  • •NOTE: Other assays for PD-L1 expression levels will not be accepted to
  • •determine eligibility. Local laboratory testing for PD-L1 status must be
  • •performed on tumor tissue samples meeting the requirements specified in
  • •Inclusion Criterion 5.
  • •7. Has measurable disease based on RECIST 1.1 (Appendix 7 of the protocol), as
  • •determined by the investigator.
  • •8. Has an ECOG PS (Appendix 1 of the protocol) of 0 or 1.
  • •9. Has adequate organ function, as defined in Table 1 of the protocol.
  • •10. If of childbearing potential, female participants must be willing to use
  • •adequate contraception. Contraceptive use by female participants should be
  • •consistent with local regulations regarding the methods of contraception for
  • •those participating in clinical studies.
  • •A female participant is eligible to participate if she is not pregnant or
  • •breastfeeding, and 1 of the following conditions applies:
  • •- Is a woman of non-childbearing potential as defined in Appendix 3 of the
  • •- Is a woman of childbearing potential

排除标准

  • •Participants are excluded from the study if any of the following criteria apply.
  • •1. Has NSCLC with a tumor that harbors any of the following molecular
  • •alterations:
  • •a. EGFR mutations that are sensitive to available targeted inhibitor therapy
  • •(including, but not limited to, deletions in exon 19, exon 20 insertion
  • •mutation, and exon 21 [L858R] substitution mutation). All participants with
  • •nonsquamous histology must have been tested for EGFR mutation status using a
  • •tissue-based test; use of an approved test is strongly encouraged. Participants
  • •with squamous histology do not need to be tested for EGFR mutation status.
  • •Participants with nonsquamous histology and unknown or indeterminate EGFR
  • •status are excluded.
  • •b. ALK translocations that are sensitive to available targeted inhibitor
  • •therapy. All participants with nonsquamous histology must have been tested for
  • •ALK fusion mutation status using a tissue-based test; use of an approved test
  • •is strongly encouraged. Participants with squamous histology do not need to be
  • •tested for ALK mutation status. Participants with nonsquamous histology and
  • •with unknown or indeterminate ALK status are excluded.
  • •c. Any other known genomic aberrations or oncogenic driver mutations for which
  • •a locally approved targeted therapy is available for first-line treatment of
  • •locally advanced or metastatic NSCLC.
  • •2. Has had major surgery within 4 weeks of the first dose of study intervention
  • •or has received lung radiation therapy of >30 Gy (for any purpose, including
  • •palliatively) within 6 months prior to the first dose of study intervention.
  • •3. Has received prior therapy with any immune-checkpoint inhibitors, including
  • •antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other
  • •checkpoint pathways.
  • •4. Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime.
  • •5. Has an invasive malignancy or history of invasive malignancy other than the
  • •disease under study within the last 5 years, except as noted below:
  • •a. Participants may be enrolled in the study with a history of any other
  • •invasive malignancy for which the participant was definitively treated, from
  • •which the participant has been disease-free for at least 2 years, and which, in
  • •the opinion of the principal investigator and sponsor/medical monitor, is not
  • •expected to affect the evaluation of the effects of the study intervention on
  • •the currently targeted malignancy.
  • •b. Participants with curatively treated basal cell carcinoma of the skin,
  • •superficial bladder cancer, squamous cell carcinoma of the skin, in situ
  • •cervical cancer, and/or in situ breast cancer may be enrolled in the study.
  • •6. Has known symptomatic, untreated, or actively progressing brain metastases.
  • •a. Participants with non-leptomeningeal brain metastases who have received
  • •prior therapy for brain metastases and have radiographically stable CNS disease
  • •(typically determined with 2 brain scans collected at least 4 weeks apart) may
  • •participate, provided they are neurologically stable (i.e., any neurologic
  • •symptoms that developed either as a result of the brain metastases or their
  • •treatment must have returned to baseline or resolved) for at least 2 weeks
  • •before randomization and have been off corticosteroids for at least 3 days
  • •prior to the date of randomization.
  • •b. Any leptomeningeal

研究者

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