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
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
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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