A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer - MK7684A-008

Merck Sharp & Dohme (MSD)0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 28

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

•1. Has histologically or cytologically confirmed diagnosis of ES-SCLC in need
•of first-line therapy.
•2. Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American
•Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules
•that are too extensive or have tumor/nodal volume that is too large to be
•encompassed in a tolerable radiation plan.
•3. Is male or female, at least 18 years of age at the time of providing
•documented informed consent.
•4. Male participants are eligible to participate if they agree 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 after
•the last dose of the intervention is as follows:
•- Etoposide, cisplatin, or carboplatin: 95 days
•- Blinded study intervention: no contraception measures
•Refrain from donating sperm
•PLUS either:
•Be abstinent from heterosexual intercourse as their preferred and usual
•lifestyle (abstinent on a long-term and persistent basis) and agree to remain
•Must agree to use contraception unless confirmed to be azoospermic as
•detailed below:
•- Agree to use a male condom plus partner use of an additional contraceptive
•method when having penile-vaginal intercourse with a WOCBP who is not currently
•- 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.
•5. A female participant is eligible to participate if she is not pregnant or
•breastfeeding, and at least one of the following conditions applies:
•Is not a WOCBP
•Is a WOCBP and using a contraceptive method that is highly effective, with
•low user dependency, or be abstinent from heterosexual intercourse as their
•preferred and usual lifestyle (abstinent on a longterm 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 after the last dose of the intervention is as follows:
•- Etoposide, cisplatin, or carboplatin: 180 days
•- Blinded study intervention: 5 months
•The investigator should evaluate the potential for contraceptive method failure
•in relationship to the first dose of study intervention.
•- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours
•before the first dose of study intervention.
•- If a urine test cannot be confirmed as negative, a serum pregnancy test is
•required. In such cases, the participant must be excluded from participation if
•the serum pregnancy result is positive.
•- Additional requirements for pregnancy testing during and after study
另有 2 项未显示

排除标准

•1. Is considered a poor medical risk due to a serious, uncontrolled medical
•disorder or nonmalignant systemic disease. Examples include, but are not
•limited to, uncontrolled major seizure disorder, unstable spinal cord
•compression, or severe or life-threatening superior vena cava
•2. Has received prior treatment (systemic therapy including investigational
•agents, curativeintent radiotherapy, or curative-intent surgical resection) for
•3. Is expected to require any other form of antineoplastic therapy for SCLC
•while on study.
•4. Has received a live or live-attenuated vaccine within 30 days before the
•first dose of study intervention. Administration of killed vaccines are allowed.
•5. Has received an investigational agent or has used an investigational device
•within 4 weeks prior to the first dose of study administration.
•6. 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 the first dose of study
•medication.
•7. Has a known additional malignancy that is progressing or has required active
•treatment within the past 3 years.
•8. Has known active CNS metastases and/or carcinomatous meningitis.
•Participants with brain metastases may participate only if they satisfy all of
•the following:
•Completed treatment (eg, whole brain radiation treatment, stereotactic
•radiosurgery, or equivalent) at least 14 days before the first dose of study
•intervention
•Have no evidence of new or enlarging brain metastases confirmed by
•posttreatment repeat brain imaging (preferably using the same modality)
•performed at least 4 weeks after treatment and within the screening period, and
•Are neurologically stable without the need for steroids at least 7 days
•before the first dose of study intervention as per local site assessment.
•9. Has a history of severe hypersensitivity reaction (>=Grade 3) to any study
•intervention and/or any of its excipients (refer to the IB and/or approved
•product label(s) for a list of excipients).
•10. 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.
•11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that
•required steroids or has current pneumonitis/interstitial lung disease.
•12. Has a known history of, or active, neurologic paraneoplastic syndrome.
•13. Has an active infection requiring systemic therapy.
•14. Has a known history of HIV infection. No HIV testing is required unless
•mandated by local health authority.
•15. Has a known history of Hepatitis B (defined as HBsAg reactive) or known
•active Hepatitis C virus (defined as HCV RNA [qualitative] is detected)
•16. Has a history or current evidence of any condition, therapy, or laboratory
•abnormality that might confound the results of the study, interfere with the
•participant's participation for the full duration of the study, or is not in
•the best interest of the participant to partici

研究者

发起方

Merck Sharp & Dohme (MSD)

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