NL-OMON56356招募中2 期
A Randomized, Open-Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone In Participants with Advanced Nonsmall Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (COSTAR Lung) - 213410 - COSTAR Lung
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participant is >=18 years old
- •2. Participant has histologically or cytologically proven advanced or
- •metastatic NSCLC,
- •and only squamous or nonsquamous cell carcinoma.
- •3. Participant has received no more than 2 prior lines of therapy for advanced
- •or metastatic disease, which must only include a platinum-based doublet
- •chemotherapy regimen and an anti-PD-(L)1 antibody. Participants previously
- •treated with targeted therapies, including angiogenesis inhibitors are not
- •a. Two components of treatment must have been received in the same line or as
- •lines of therapy as follows:
- •A maximum of 1 line of therapy containing a platinum-based chemotherapy in the
- •metastatic setting
- •A maximum of 1 line of therapy containing an anti-PD-(L)1 antibody
- •4. Participant has measurable disease, that is, presenting with at least 1
- •measurable lesion
- •per RECIST v1.1
- •5. Participant has documented radiological disease progression on prior
- •platinum-based
- •chemotherapy and on prior anti-PD-(L)1 therapy according to RECIST v1.1.
- •6. Participant agrees to submit an archival FFPE tumor tissue specimen that was
- •on or after diagnosis of metastatic disease from location(s) not irradiated
- •prior to biopsy.
- •7. Participant has documented PD-L1 status by the 22C3 pharmDx assay
- •(Agilent/Dako), the SP263 assay (Roche) or a LDT with published evidence of
- •concordance with the 22C3 pharmDx assay. If a prior PD-L1 result by this
- •testing methods is not available at the time of Screening, the participant must
- •submit archival or fresh tumor tissue to be tested locally using 1 of these
- •testing methods, or, if not available, centrally, using the 22C3 pharmDx assay.
- •8. Participant has an ECOG performance status score of 0 or 1.
- •9. Participant has a life expectancy of at least 3 months and is anticipated to
- •be able to complete 4 cycles of docetaxel treatment.
- •10. Participant has adequate organ function as defined in the protocol.
- •11. Participant has recovered to Grade <=1 from any prior treatment-related
- •toxicities at the time of randomization. A participant with Grade 2 alopecia is
- •an exception to this criterion and may qualify for this study.
- •12. Contraceptive use by male and female participants should be consistent with
- •local regulations regarding the methods of contraception for those
- •participating in clinical
排除标准
- •1. Participant has been previously treated with an anti-PD-(L)1 or anti-PD-L2
- •agent that resulted in permanent discontinuation due to an AE.
- •2. Participant has been previously treated with an anti-TIM-3 or anti-CTLA-4
- •agent or docetaxel.
- •3. Participant has a documented sensitizing EGFR, ALK, or ROS-1 mutation.
- •Participants
- •whose tumors have not been tested for these driver mutations and therefore who
- •have unknown driver mutation status are not eligible. Participants with
- •squamous histology do not need to be tested for these driver mutations.
- •4. Participant had radiological or clinical disease progression <=8 weeks after
- •initiation of prior
- •anti-PD-1 or anti-PD-L1 antibody. The clinical disease progression should have
- •been confirmed by a subsequent radiological scan.
- •5. Participant has received radiation to the lung that is >30 Gy within 6
- •months prior to the
- •first dose of study treatment.
- •6. Participant has completed palliative radiotherapy within 7 days prior to the
- •first dose of
- •study treatment.
- •7. Participant is ineligible if any of the following hepatic characteristics
- •are present:
- •a. Alanine aminotransferase (ALT >2.5×ULN
- •b. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
- •>1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP)
- •c. Bilirubin >1×ULN
- •d. Current active liver or biliary disease
- •8. Participant has a corrected QT interval (QTc) >450 msec
- •9. Participant has had major surgery within 3 weeks prior to the first dose of
- •study treatment or has not adequately recovered from any AEs (Grade <=1) and/or
- •complications from any major surgery.
- •10. Participant has an additional malignancy or a history of prior malignancy,
- •with the exception of adequately treated basal or squamous skin cancer,
- •cervical carcinoma in situ, or bladder carcinoma in situ without evidence of
- •disease, or had a malignancy treated with curative intent and with no evidence
- •of disease recurrence for 5 years since the initiation of that therapy.
- •11. Participant has known new or progressive brain metastases and/or
- •leptomeningeal
- •metastases.
- •12. Participant has tested positive for the following at screening or within 3
- •months before the first dose of the study treatment:
- •a. presence of hepatitis B surface antigen
- •b. presence hepatitis C antibody in the absence of an RNA test voor hepatitis C
- •13. Participant has an active infection requiring systemic therapy within 1
- •week prior to the anticipated first dose of study treatment.
- •14. Participant has known HIV (positive for HIV-1 or HIV-2 antibodies).
- •15. Participant has active autoimmune disease that required systemic treatment
- •in the past 2 years, is immunocompromised in the opinion of the Investigator,
- •or is receiving systemic immunosuppressive treatment.
- •17. Participant has symptomatic ascites or pleural effusion.
- •18. Participant has current interstitial lung disease, current pneumonitis, or
- 另有 6 项未显示
研究者
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