NCT03656094Unknown2 期
Chemotherapy Plus Pembrolizumab After Progression With Previous PD-1/PD-L1 Inhibitors in Patients With Advanced Non-small Cell Lung Cancer: Placebo-controlled Randomized Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
After progression to previous PD-1/L1 inhibitors (pembrolizumab, nivolumab, or atezolizumab), physicians' choice chemotherapy plus pembolizumab (or placebo) will be administered (3 weeks per cycle) until disease progression or unacceptable toxicity.
详细描述
Previous PD-1/PD-L1 inhibitors should be 2nd or 3rd line therapy for advanced NSCLC. There should be no systemic therapy after previous PD-1/PD-L1 therapy, before the enrollment to this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male /female participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed diagnosis of
- •Histologically confirmed non-small cell carcinoma
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
- •Received one or two cytotoxic chemotherapy for advanced NSCLC including at least one platinum-doublet
- •Has received prior therapy with an anti-PD-1, anti-PD-L1 agents (monotherapy) and progression to last PD-1/PD-L1 inhibitors. The last PD-1/PD-L1 inhibitor should be administered 6 weeks before the study enrollment, and no other systemic therapy should be done between the interval.
- •At least one measurable lesion Have measurable disease based on RECIST 1.
- •Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Available data for PD-L1 IHC results (any of one tested by 22C3, SP263, or SP142) irrespective of expression level.
- •EGFR and ALK wild type
排除标准
- •A WOCBP who has a positive urine pregnancy test within 72 hours prior to [randomization/allocation] (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation].
- •Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
- •Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- •Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- •Has received a live vaccine within 30 days prior to the first dose of study drug. 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 killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to the first dose of study treatment.
- •Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- •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 to the first dose of study drug.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, well differentiated thyroid carcinoma, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- •Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. Patients with oligo (≤5) brain metastasis with size less than 1cm can be enrolled without prior radiotherapy, if the tumors are regarded as asymptomatic and stable, based on follow-up brain MRIs checked intervals of at least 3 months. However, all patients with previously non-irradiated brain metastases should have brain MRI checked within 4 weeks before starting administration of study drugs.
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any PD-1/PD-L1 inhibitors.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. 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 not considered a form of systemic treatment.
- •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a known history of Human Immunodeficiency Virus (HIV)
- •Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
研究组 & 干预措施
Pembrolizumab plus chemotherapy
Experimental
Pembrolizumab (200 mg) plus chemotherapy (physicians' choice among docetaxel, pemetrexed, or vinorelbine) every 3 weeks
干预措施: Pembrolizumab plus chemotherapy (Drug)
Placebo plus chemotherapy
Active Comparator
Placebo plus chemotherapy (physicians' choice among docetaxel, pemetrexed, or vinorelbine) every 3 weeks
干预措施: Placebo plus chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 60 moths
Time interval from enrollment to disease progression or death
次要结局
- Toxicity by CTCAE(60 months)
- Overall survival (OS)(60 months)
- Objective Response Rate (ORR)(up to 60 months)
研究者
Jong-Mu Sun
Associate professor
Samsung Medical Center
研究点 (1)
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