EUCTR2018-004721-88-PL进行中（未招募）1 期
A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
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
- 735
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
- •- Have a histologically or cytologically confirmed diagnosis squamous NSCLC. Patients with mixed histology (eg, adenosquamous) are allowed if there is squamous component in the specimen
- •- Have stage IV (T any, N any, M1a, M1b, or M1c as per AJCC 8th edition) squamous NSCLC
- •- Have measurable disease based on RECIST 1.1, as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- •- Has (or legally acceptable representative) provided documented
- •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 trial without participating in
- •Future Biomedical Research
- •- Has a CR/PR or stable disease of their NSCLC as determined by central
- •imaging review after completion of study-specified Induction Phase
- •- Have an ECOG performance status score of 0 or 1 as assessed at Prerandomization
- •visit (most recent assessment within this visit).
- •- All AEs (with the exception of alopecia, Grade 2 fatigue, and Grade =2
- •endocrine-related AEs requiring treatment or hormone replacement. For
- •anemia and creatinine clearance, the guidelines provided in Table 3 may
- •be followed) resolved to Grade =1 or baseline following Induction Phase
- •- Have adequate organ function, as indicated by the laboratory values in
- •Table 3 above.
- •- Are not taking medications or vaccinations specifically prohibited
- •- 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.
- •- Have not withdrawn consent to continue treatment.
- •- Continue to derive clinical benefit from study participation according to
- •investigator's discretion
- •- 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
- •- Have provided archival tumor tissue sample or newly obtained core or incisional 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
- •- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
- •- Have a life expectancy of at least 3 months
- •- Has adequate organ function; all screening laboratory tests should be performed within 10 days prior to initiation of study treatment
- •- Be =18 years of age on day of signing informed consent
- •- Male participants are eligible to participate if they agree to the
- •following during the intervention period for at least 180 days after the
- •last dose of study intervention:
- •Refrain from donating sperm
- •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 [Appendix 5]), as detailed
- •Agree to use male condom plus partner use of an additional
排除标准
- •- Non-squamous histology NSCLC
- •- Additional malignancy progressing or progressed within the past 3 years requiring active treatment
- •- Central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases, and also are off steroids 3 days prior to dosing with study medication
- •- Autoimmune disease that has required systemic treatment in the past 2 years
- •- Immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or other immunosuppressive therapy within 7 days prior to first dose
- •- History of (noninfectious) pneumonitis requiring systemic steroids, interstitial lung disease
- •- Known history of active tuberculosis, HIV infection, HBV infection, or active HCV infection
- •- Current pneumonitis
- •- Prior treatment with olaparib or any other PARP inhibitor
- •- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agent directed to another stimulatory or co-inhibitory T cell receptor
- •- Prior systemic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
- •- Receiving either strong or moderate inducers or inhibitor of CYP3A4 that cannot be discontinued for the duration of the study
研究者
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