A Multicenter, Open-label, Single-arm, Expanded Access Protocol of AMG 510 (INN Sotorasib) for the Treatment of Subjects in Selected European Countries with Previously Treated Locally Advanced and Unresectable or Metastatic Non-small Cell Lung Cancer with KRAS p.G12C Mutation - AMG 510 (INN Sotorasib) Expanded Access Protocol in Selected European Countries

AMGEN INC.0 个研究点目标入组 638 人开始时间: 2021年6月7日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
•- Age >= 18 years.
•- Pathologically documented, locally-advanced, and unresectable or metastatic non-small cell lung cancer.
•- Have documentation of KRAS p.G12C mutation per local testing guidelines or a screening for another Amgen sotorasib study.
•- Subject has exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy, PD-1/PD-L1 immunotherapy, and docetaxel (unless contraindicated).
•- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
•*Please refer to protocol for the full list
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 375
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 263

•- Mixed small-cell lung cancer and NSCLC histology
•- Subjects with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to study day 1
•Other Medical Conditions
•- Subjects with active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C virus (HCV) (positive HCV RNA)
•- Subjects with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible
•- HBV carriers or those subjects receiving antiviral therapy for HBV or HCV are not eligible to participate
•- Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
•- Current active malignancy other than NSCLC with the exception of those with a negligible risk of metastases or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal cell carcinoma, cutaneous squamous cell carcinoma, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
•- Leptomeningeal disease
•*Please refer to the protocol for the full list

发起方

AMGEN INC.