EUCTR2017-001832-21-IE进行中（未招募）1 期
A Phase III, Randomized, Double-blind Trial of Platinum DoubletChemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 786
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
- •1. Male/female participants who are at least 18 years of age on the day
- •of signing informed consent with previously untreated and pathologically
- •confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. Lymph node
- •disease requires pathologic confirmation, while T3 (rib destruction)
- •disease requires only radiographic documentation. A PET scan may be
- •utilized as a surrogate for pathologic staging of N1 lymph nodes for
- •participants with T2b and T4 tumors (the presence or absence of tumor
- •in the N1 lymph nodes will not change the actual stage by which the
- •participant is stratified). Similarly, biopsy confirmation of N2 disease is
- •not required for pathologically confirmed T3N1 tumors and T4N0-1
- •tumors, as knowledge of the N2 status will not change the stage.
- •2. Be able to undergo protocol therapy, including necessary surgery.
- •3. If male, agrees to the following during the intervention period and for
- •at least the time needed to eliminate each study intervention after the
- •last dose of study intervention. The length of time required to continue
- •contraception for each study intervention is as follows:
- •- Chemotherapy: 95 days
- •Refrains from donating sperm
- •PLUS either:
- •Abstains from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long-term and persistent basis) and agrees to
- •remain abstinent
- •Uses contraception unless confirmed to be azoospermic (vasectomized
- •or secondary to medical cause, documented from the site personnel's
- •review of the participant's medical records, medical examination, or
- •medical history interview) as detailed below:
- •*Uses a male condom plus partner use of an additional contraceptive
- •method when having penile-vaginal intercourse with a WOCBP who is
- •not currently pregnant. .
- •*Contraceptive use by men should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •studies. If the contraception requirements in the local label for any of
- •the study interventions is more stringent than the requirements above,
- •the local label requirements are to be followed
- •4. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •Not a WOCBP
- •A WOCBP and:
- •* Uses a contraceptive method that is highly effective (with a failure rate
- •of <1% per year), with low user dependency, or be abstinent from
- •heterosexual intercourse as their preferred and usual lifestyle (abstinent
- •on a long-term and persistent basis), during the intervention period and
- •for at least the time needed to eliminate each study intervention after
- •the last dose of study intervention and agrees not to donate eggs (ova,
- •oocytes) to others or freeze/store for her own use for the purpose of
- •reproduction during this period. The length of time required to continue
- •contraception for each study intervention is as follows:
- •-Chemotherapy: 180 days
- •-MK-3475: 120 days
- •The investigator should evaluate the potential for contraceptive method
- 另有 8 项未显示
排除标准
- •1. Has one of the following tumor locations/types:
- •- NSCLC involving the superior sulcus
- •- Large cell neuro-endocrine cancer (LCNEC)
- •- Sarcomatoid tumor
- •2. Has a history of (non-infectious) pneumonitis /interstitial lung
- •disease that required steroids or has current pneumonitis/interstitial
- •lung disease that requires steroids.
- •3. Has an active infection requiring systemic therapy.
- •4. Has had an allogenic tissue/solid organ transplant.
- •5. Has a known severe hypersensitivity (= Grade 3) to pembrolizumab,
- •its active substance and/or any of its excipients.
- •(Refer to the respective Investigator'sBrochure for a list of excipients.)
- •6. Has a known severe hypersensitivity (= Grade 3) to any of the study
- •chemotherapy agents and/or to any of their excipients.
- •7. 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.
- •8. Has a known history of human immunodeficiency virus (HIV)
- •infection. No HIV testing is required unless mandated by local health
- •9. Has a known history of Hepatitis B (defined as Hepatitis B surface
- •antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as
- •HCV RNA [qualitative] is detected) infection.
- •10. Has a known history of active tuberculosis (TB; Bacillus
- •tuberculosis).
- •11. Has a history or current evidence of any condition, therapy, or
- •laboratory abnormality that might confound the results of the trial,
- •interfere with the participant's participation for the full duration of the
- •trial, or is not in the best interest of the participant to participate, in the
- •opinion of the treating investigator.
- •12. Has known psychiatric or substance abuse disorders that would
- •interfere with cooperating with the requirements of the trial.
- •13. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2
- •agent or with an agent directed to another co inhibitory T-cell
- •receptor (eg, CTLA-4, OX-40, CD137).
- •14. Has received prior systemic anticancer therapy including
- •investigational agents for the current malignancy prior to
- •randomization/allocation.
- •15. Has received prior radiotherapy within 2 weeks of start of trial
- •treatment. Participants must have recovered from all radiation-related
- •toxicities, not require corticosteroids, and not have had radiation
- •pneumonitis.
- •16. Has received a live or live attenuated vaccine within 30 days prior to
- •the first dose of trial drug. Examples of live vaccines include, but are not
- •limited to, the following: measles, mumps, rubella, varicella/zoster
- •(chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and
- •typhoid vaccine. Seasonal influenza vaccines for injection are generally
- •killed virus vaccines and are allowed; however, intranasal influenza
- 另有 9 项未显示
研究者
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