A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer

Merck Sharp & Dohme LLC0 个研究点目标入组 1,005 人开始时间: 2019年4月24日最近更新: 2024年5月6日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme LLC
入组人数: 1,005

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Have a histologically confirmed or cytologically confirmed diagnosis of nonsquamous NSCLC.
•2. Have stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer (AJCC) 8th Edition) nonsquamous NSCLC.
•3. Have confirmation that EGFR, ALK, or ROS1-directed therapy is not indicated (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements, OR presence of a K-Ras mutation).
•4. Have measurable disease, based on RECIST 1.1, as determined by the local site investigator/radiology assessment. Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
•5. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
•6. Have a life expectancy of at least 3 months.
•7. Have an ECOG performance score of 0 or 1 assessed within 7 days prior to the administration of study intervention.
•8. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
•9. Have adequate organ function. All screening laboratory tests should be performed within 10 days prior to the first dose of study intervention.
•10. Be at least 18 years of age at the time of signing the informed consent.
•11. Male participants 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 study intervention:
•- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent
•- Agree to use contraception, unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
•-Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
•12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
•a) Is not a WOCBP
•b) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate <1% per year), 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 180 days 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 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 urine pregnancy test as required by local regulations) within 24 hours (72 hours for serum) before the first dose of study intervention.
•13. Have (or legally acceptable representative) provided documented informed consent/assent for the study. The partic

排除标准

•1. Has predominantly squamous cell histology NSCLC.
•2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
•3. Has known active central nervous system metastases and/or carcinomatous meningitis.
•4. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
•5. Participant has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
•6. Has 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.
•7. 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 intervention.
•8. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
•9. Has an active infection requiring systemic therapy.
•10. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required, unless mandated by local health authority.
•11. Has a known history of hepatitis B or known active hepatitis C virus infection.
•12. Has a known history of active tuberculosis.
•13. Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
•14. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
•15. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
•16. Before the first dose of study intervention:
•a. Has received prior systemic cytotoxic chemotherapy for metastatic disease.
•b. Has received antineoplastic biological therapy (eg, erlotinib, crizotinib, cetuximab) for metastatic disease.
•c. Had major surgery (<3 weeks prior to study intervention) or has not recovered from any effects of any major surgery.
•17. Has received prior therapy with olaparib or with any other PARP inhibitor.
•18. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
•19. Is expected to require any other form of antineoplastic therapy while on study.
•20. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
•21. Has received a live or live attenuated vaccine within 30 days prior to the first dose of study drug.
•22. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, other than an aspirin dose =1.3 g per day, for a 5-day period (an 8-day period for long-acting agents, such as piroxicam).
•23. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
•24. Received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor or recombinant erythropoietin) within 28 days prior to the first dose of study intervention.
•25. Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.
•26. Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.
•27. Is current

研究者

发起方

Merck Sharp & Dohme LLC

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