A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 240 人开始时间: 2021年4月19日最近更新: 2024年5月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 240

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

•1. Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8).
•2. Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy.
•3. Has PD on treatment with one prior anti-PD-1/PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
•4. Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease.
•5. Has measurable disease based on RECIST 1.1, as determined by the local site assessment.
•6. Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
•7. Is male or female, =18 years of age at the time of providing documented informed consent.
•8. Has a life expectancy of at least 3 months.
•9. Has an ECOG Performance Status of 0 to 1 assessed within 7 days prior to randomization.
•10. Male participants randomized to docetaxel are eligible to participate if they agree to the following during the intervention period and for at least 180 days after the last dose of docetaxel:
•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 abstinent.
•Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
•o 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 pregnant.
•o Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
•11. 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 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 120 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
•A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention.
•A WOCBP randomized to docetaxel is eligible to participate if she is using a contraceptive method that is highly effective with low user dependency or is abstinent from heterosexual intercourse as her preferred and usual lifestyle and agrees not to donate or freeze/store eggs during the intervention period and for at least 180 days after the last dose of docetaxel.
•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.
•The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to de

排除标准

•1. Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study intervention.
•2. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
•3. Has received docetaxel as monotherapy or in combination with other therapies.
•4. Has received previous treatment with another agent targeting the TIGIT receptor pathway.
•5. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
•6. Has received radiotherapy within 2 weeks of start of study intervention.
•7. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
•8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
•9. Has severe hypersensitivity (=Grade 3) to docetaxel or MK-7684A and/or any of its excipients.
•10. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment and is allowed.
•11. 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 before the first dose of study intervention.
•12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
•13. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
•14. Has an active infection requiring systemic therapy.
•15. Has a known history of HIV infection.
•16. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
•17. 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 participate, in the opinion of the treating investigator.
•18. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.
•19. If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
•20. Has had an allogenic tissue/solid organ transplant.

研究者

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

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