EUCTR2018-001316-29-NL进行中（未招募）1 期
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants - Ph2 Platform Trial of Novel Regimens vs. SoC in NSCLC
GlaxoSmithKline Research and Development Ltd.0 个研究点目标入组 105 人开始时间: 2018年12月6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
- 105
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
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1. Capable of giving signed informed consent/assent as described in Section 12.4 of protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •2. Male or female, aged 18 years or older at the time consent is obtained
- •3. Histologically or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous)
- •a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease:
- •i. A maximum of 1 line of platinum-containing chemotherapy regimen in the metastatic setting, and ii. A maximum of 1 line of PD(L)1 mAb containing regimen.
- •o PD(L)1 mAb received during a previous clinical trial may meet this requirement upon consultation with study medical monitor.
- •o Participants on the phase III PACIFIC trial (NCT02125461) experimental regimen (chemoradiotherapy followed by durvalumab) [Antonia, 2017] or received the PACIFIC regimen [chemoradiotherapy followed by PD(L)1] as part of SoC AND have relapsed within one year from the first dose of chemoradiotherapy would fulfill the protocol requirement for platinum-based chemotherapy treatment and PD-1 treatment.
- •This would be considered a single line of treatment for the purpose of PD(L)1 line of therapy stratification.
- •o PD(L)1 mAb can be administered with the platinum-based chemotherapy regimen and this would count as a single line of therapy.
- •o PD(L)1 mAb may be counted as a prior treatment if the agent is approved in at least 1 country for the treatment of cancer.
- •o Participants who have completed 2 years of pembrolizumab or another PD(L)1 mAb, discontinue from that therapy, experience disease progression, and are then retreated with PD(L)1, will be considered as
- •having had one line of PD(L)1 therapy.
- •o Adjuvant or neo-adjuvant systemic anticancer therapy will not count toward the 2 lines of therapy unless disease recurs during the first year following the start of adjuvant chemotherapy.
- •b. Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.
- •4. Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1 (see Appendix 12 of protocol for definition of a measurable lesion)
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
- •6. A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable. See Section 9.7.2 of protocol for further details on tumor tissue requirements.
- •7. Adequate organ function as defined in Table 6 in protocol
- •8. A male participant must agree to use a highly effective contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- •Note: If the participant is randomized to the SoC regimen only, then the duration of contraception is at least 3 days after the last dose of study treatment.
- •9. A female participant is eligible to participate if she is not pregnant (see Appendix 6 of protocol), not breastfeeding, a
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
- •a. Docetaxel at any time
- •b. Any of the investigational agents being tested in the current study, including experimental ICOS agonist
- •c. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
- •d. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1
- •or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
- •2. Received >2 prior lines of therapy for NSCLC, including participants with BRAF molecular alterations. (See inclusion criterion #3 for eligible lines of therapy guidance of protocol)
- •Note: Patients with known EGFR/ALK/ROS1 molecular alterations are excluded from participation in this study, however patients with known exon 20 EGFR molecular alteration may be considered for inclusion in this study, if no other therapeutic options are available locally.
- •3. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except as noted below:
- •- Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GSK Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
- •- Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
- •4. Central nervous system (CNS) metastases, with the following exception:
- •Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to first dose of study treatment.
- •Note: Participants with carcinomatous meningitis or leptomeningeal spread are excluded regardless of clinical stability.
- •5. Major surgery =28 days of first dose of study treatment.
- •6. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments. Note: Participants with controlled Type 1 diabetes mellitus (T1DM) are eligible.
- •7. Receiving systemic steroids (>10 mg oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
- •Note: Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) are permitted.
- •8. Prior allogeneic/autologous bone marrow or solid organ transplantation.
- •9. Receipt of any live vaccine within 30 days prior to first dose of study treatment.
- •Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus
- •Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally kil
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