EUCTR2018-004843-22-ES进行中（未招募）1 期
A Phase 3 Study of Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) - Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 1L ES SCLC
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc0 个研究点目标入组 699 人开始时间: 2019年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 699
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 documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or incisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample
- •2. Have extensive stage disease defined as Stage IV (T any, N any, M 1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
- •3. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology review. Lesions that appear measurable, but have undergone palliative irradiation, cannot be target lesions
- •4. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
- •5. Have an ECOG Performance Status of 0 to 1 assessed within 7 days prior to the administration of study intervention
- •6. Have a life expectancy of at least 3 months
- •7. Have adequate organ function; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention
- •8. Be at least 18 years of age at the time of signing the informed consent
- •9. A male participant must agree to use contraception during the treatment period and for at least 180 days following the last dose of pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy
- •10. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- •- Not a woman of childbearing potential (WOCBP)
- •- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 180 days following the last dose of pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy
- •11. Has (or legally acceptable representative if applicable) provided written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
- •Additional Criteria Applicable to Maintenance Phase Only – Prior to Randomization
- •12. Have a CR/PR or stable disease of their SCLC after completion of the study-specified Induction Phase, as determined by central imaging review
- •13. Have an ECOG score of 0 or 1
- •14. All AEs (except alopecia, Grade 2 fatigue, and endocrine-related AEs Grade =2 requiring treatment or hormone replacement) resolved to Grade =1 or baseline following Induction Phase treatment
- •15. Have adequate organ function
- •16. Are not taking medications or vaccinations specifically prohibited in the Exclusion Criteria
- •17. Are not pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting from the pre-randomization visit through 180 days after the last dose of study intervention
- •18. Have not withdrawn consent to continue treatment
- •19. Continue to derive clinical benefit from study participation according to investigator’s discretion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for thi
排除标准
- •1. Has received prior systemic therapy for the treatment of SCLC
- •2. Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study
- •3. Has a known history of interstitial lung disease. Lymphangitic spread of the SCLC is not exclusionary
- •4. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •5. Has a known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis
- •6. Has had major surgery within 3 weeks of starting study intervention or has not recovered from any effects of any major surgery
- •7. Has a known additional malignancy that is progressing or requires active treatment
- •8. Has a known hypersensitivity to the components or excipients of cisplatin, carboplatin, etoposide, or olaparib
- •9. 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
- •10. Has 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) is not considered a form of systemic treatment
- •11. Has a known history of, or active, neurologic paraneoplastic syndrome
- •12. Has severe hypersensitivity (Grade =3) to pembrolizumab and/or any of its excipients
- •13. Has 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 hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus RNA [qualitative] is detected) infection
- •16. Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis)
- •17. Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible
- •18. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 180 days after the last dose of study intervention
- •19. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
- •20. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
- •21. Has 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
- •22. 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 ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome
- •23. Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption)
- •24. Has received a live vaccine w
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