2023-507776-42-00招募中3 期
A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 60
- 主要终点
- 1. Progression-free survival (PFS)
研究概览
简要总结
- To compare MK-1084 plus pembrolizumab with placebo plus pembrolizumab with respect to PFS assessed according to RECIST 1.1 by BICR
To compare MK-1084 plus pembrolizumab with placebo plus pembrolizumab with respect to OS
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- •Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- •Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
- •If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline
- •If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- •If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
排除标准
- •Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible.
- •Has known active central nervous system metastases and/or carcinomatous meningitis
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has active autoimmune disease that has required systemic treatment in the past 2 years
- •Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Is HIV-infected and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has history of allogenic tissue/solid organ transplant
- •Has not fully recovered from any effects of major surgical procedure
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- •Has known history of, or active, neurologic paraneoplastic syndrome
- •Has an active infection requiring systemic therapy, with exceptions
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- •Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
- •Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
- •Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
- •Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
研究组 & 干预措施
MK-1084, MK-1084
Test
干预措施: MK-1084 (Drug)
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Test
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion (Drug)
Placebo to MK-1084 50 mg, Placebo to MK-1084 25 MG
Placebo
干预措施: Placebo to MK-1084 50 mg (Drug)
Placebo to MK-1084 50 mg, Placebo to MK-1084 25 MG
Placebo
干预措施: Placebo to MK-1084 25 MG (Drug)
结局指标
主要结局
1. Progression-free survival (PFS)
1. Progression-free survival (PFS)
2. Overall survival (OS)
2. Overall survival (OS)
次要结局
- 1. Objective response rate (ORR)
- 2. Duration of response (DOR)
- 3. Number of participants who experience one or more Adverse Events (AEs)
- 4. Number of participants who discontinue study treatment due to an AE
- 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
- 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30
- 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30
- 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30
- 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13
- 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13
- 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30
- 12. TTD in the physical functioning (items 1-5) score, on the EORTC-QLQ-C30
- 13. TTD in the role functioning (items 6-7) score, on the EORTC QLQ-C30
- 14. TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30
- 15. TTD in the cough (item 31) score, on the EORTC QLQ-Lung Cancer version (LC13)
- 16. TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13
研究者
Azadeh Namakydoust
Scientific
Merck Sharp & Dohme LLC
研究点 (60)
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