A Study of Alectinib versus Pemetrexed or Docetaxel in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

-Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive
-Patient had received two prior systemic lines of therapy for advanced or metastatic disease, which must have included one line of platinum-based chemotherapy and one line of crizotinib (progression on or intolerability to crizotinib)
-Prior CNS or leptomeningeal metastases allowed if asymptomatic.
-Patients with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
-Measurable disease (by Response Evaluation Criteria in Solid Tumors v1.1) prior to the administration of study treatment
-Age >=18 years old
-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2
-Adequate hematologic and renal function
-Life expectancy of at least 12 weeks
-For all females of childbearing potential, a negative pregnancy test must be obtained prior to randomization and within 3 days before starting study treatment
-For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug (in addition, refer to the local label for pemetrexed and docetaxel)
-For men: agreement to remain abstinent or use a contraceptive method that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the last dose of study drug (in addition, refer to the local label for pemetrexed and docetaxel)

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

-Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection or in situ carcinoma of the cervix)
-Patients who have received any previous ALK inhibitor other than crizotinib
-Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection
-Patients with liver disease
-National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
-History of organ transplant
-Patients with baseline QTc >470 milliseconds or symptomatic bradycardia
-Pregnant or lactating women
-Known HIV positivity or AIDS-related illness
-Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 8/26/2024

A Study of Alectinib versus Pemetrexed or Docetaxel in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer

Recruitment & Eligibility

Study & Design

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