EUCTR2018-003824-35-PL进行中（未招募）1 期
A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) with or without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants with Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006) - LEAP-006
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
- 714
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
- •Participant must:
- •1. Have a histologically or cytologically confirmed diagnosis of Stage IV
- •(American Joint Committee on Cancer [AJCC], version 8 or current
- •version) nonsquamous NSCLC.
- •2. Have confirmation that EGFR , ALK , or ROS1 directed therapy is not
- •indicated as primary treatment (documentation of absence of tumor
- •activating EGFR mutations AND absence of ALK and ROS1 gene
- •rearrangements OR presence of a KRAS mutation).
- •3. Have measurable disease per RECIST 1.1.
- •4. Have provided archival tumor tissue sample or newly obtained core or
- •excisional biopsy of a tumor lesion not previously irradiated. FFPE tissue
- •blocks are preferred to slides. Newly obtained biopsies are preferred to
- •archived tissue. Formalin fixed specimens after the participant has been
- •diagnosed with metastatic disease are preferred. Biopsies obtained prior
- •to receipt of adjuvant/neoadjuvant chemotherapy are permitted if
- •recent biopsy is not feasible.
- •5. Be male or female =18 years of age inclusive, at the time of signing
- •the informed consent form (ICF).
- •6. Have a life expectancy of at least 3 months.
- •7. Have an ECOG performance status of 0 or 1 within 7 days prior to the
- •first dose of study intervention but before randomization.
- •8. Male participants are eligible to participate if they agree to the
- •following during the intervention period and for at least 7 days after the
- •last dose of lenvatinib/matching placebo and up to 180 days after the
- •last dose of chemotherapeutic agents:
- •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:
- •- 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. Note: Men with a pregnant or
- •breastfeeding partner must agree to remain abstinent from penilevaginal
- •intercourse or use a male condom during each episode of penilevaginal
- •penetration.
- •9. 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 post pembrolizumab and 30
- •days post-lenvatinib/matching placebo, and up to 180 days post last
- •dose of chemotherapeutic agents, whichever occurs last. The
- •investigator should evaluate the potential for contraceptive method
- •failure (ie, noncompliance, recently initiated) in relationship to the first
- 另有 10 项未显示
排除标准
- •If participant:
- •1. Has known untreated central nervous system (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 [the repeat imaging must be performed during the screening
- •period]), clinically stable, and have not required steroids for at least 14
- •days prior to the first dose of study intervention.
- •2. Has a history of (noninfectious) pneumonitis that required systemic
- •steroids or current pneumonitis/interstitial lung disease.
- •3. Radiographic evidence of intratumoral caviations, encasement, or
- •invasion of a major blood vessel. Additionally, the degree of proximity to
- •major blood vessels should be considered for exclusion because of the
- •potential risk of severe hemorrhage associated with tumor
- •shrinkage/necrosis after lenvatinib therapy. (In the chest, major blood
- •vessels include the main pulmonary artery, the left and right pulmonary
- •arteries, the 4 major pulmonary veins, the superior or inferior vena cava,
- •and the aorta).
- •4. 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
- •5. Has an active autoimmune disease that has required systemic
- •treatment in the 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, etc.) is allowed.
- •6. Has a diagnosis of immunodeficiency or is receiving chronic systemic
- •steroid therapy (doses exceeding 10 mg daily of prednisone equivalent)
- •or any other form of immunosuppressive therapy within 7 days prior the
- •first dose of study intervention.
- •7. Has had an allogeneic tissue/solid organ transplant.
- •8. Has a known history of human immunodeficiency virus (HIV)
- •infection. HIV testing is not required unless mandated by the local health
- •9. Has a known history of Hepatitis B (defined as Hepatitis B surface
- •antigen [HBsAg] reactive or HBV DNA detected) or known active
- •Hepatitis C virus (defined as HCV RNA [qualitative] detected or HCV
- •antibody reactive, if HCV RNA is not the local SOC) infection. No testing
- •for Hepatitis B or Hepatitis C is required unless mandated by the local
- •health authority.
- •10. Has a history of a gastrointestinal condition or procedure that in the
- •opinion of the investigator may affect oral drug absorption.
- •XML File Identifier: qJEPQMeTdBEKTWomcEoCeCFnIco=
- •11. Has active hemoptysis (at least 0.5 tsp of bright red blood) within 2
- •weeks prior to the first dose of study intervention.
- •12. Has significant cardiovascular impairment within 12 months prior to
- •the first dose of study intervention, including history of congestive heart
- •failure greater than New York Heart Association (NYHA) Class II,
- •unstable angina, myocardial infarction, cerebrovascular accident
- •(CVA)/stroke, or cardiac arrhythmia associated with hemodynamic
- •instability.
- 另有 7 项未显示
研究者
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