2025-521939-36-00招募中2 期
KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Percentage of Participants with a Dose Limiting Toxicity (DLT)
研究概览
简要总结
- To evaluate the safety and tolerability of investigational agent combinations
- To evaluate ORR per RECIST 1.1 as assessed by BICR
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 advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)
- •Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations
- •Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated
- •Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement
- •Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected
- •Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive
- •Has undetectable hepatitis C (HCV) viral load if HCV-infected
排除标准
- •Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- •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 intervention
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has a history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery or has ongoing surgical complications
- •Has HIV-infection with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- •Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
- •Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
- •Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- •Has received previous treatment with an agent targeting KRAS
- •Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before allocation/randomization
- •Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
结局指标
主要结局
Percentage of Participants with a Dose Limiting Toxicity (DLT)
Percentage of Participants with a Dose Limiting Toxicity (DLT)
Percentage of Participants who Experience at Least One Adverse Event (AE)
Percentage of Participants who Experience at Least One Adverse Event (AE)
Percentage of Participants who Discontinue Study Intervention Due to an AE
Percentage of Participants who Discontinue Study Intervention Due to an AE
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)
次要结局
- Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
- Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
- Overall Survival (OS)
- Area Under the Concentration-Time Curve (AUC) for MK-1084
- Maximum Concentration (Cmax) of MK-1084
- Trough Concentration (Ctrough) of MK-1084
研究者
Atsuko Ogino
Scientific
Merck Sharp & Dohme LLC
研究点 (4)
Loading locations...
相似试验
招募中
2 期
A clinical study of treatments for non-small cell lung cancer (MK-3475-01I)2024-518839-11-00Merck Sharp & Dohme LLC66
招募中
1/2 期
Study of MK-5684-based Therapies in Advanced Prostate Cancer2023-506288-33-00Merck Sharp & Dohme LLC127
招募中
3 期
A study to compare how well odronextamab combined with chemotherapy works and how safe it is against rituximab combined with chemotherapy, in patients with previously untreated diffuse large B-cell lymphoma2022-502785-25-00Regeneron Pharmaceuticals Inc.419
招募中
2 期
Substudy to test investigational agents in combination with pembrolizumab in PD-L1 positive treatment-naïve NSCLC in a rolling arm design2023-506933-32-00Merck Sharp & Dohme LLC38
招募中
1 期
An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.2023-505185-28-00F. Hoffmann-La Roche AG52