Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Ce… (NCT06522360) | Clinical Trial Compass
WithdrawnPhase 2
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
Stopped: 0 participants enrolled
0Started 2024-12-11
Plain-language summary
The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the disease compared with brigatinib alone. The safety of these combinations will also be studied.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
✓. Documented ALK re-arrangement as detected by: (1) FISH, (2) IHC, (3) tissue NGS, or (4) cfDNA NGS
✓. Subjects can be enrolled as (a) TKI naïve or (b) after/during 12 weeks of first line brigatinib treatment without disease progression or (c) after 4 weeks of first line alectinib, lorlatinib or ensartinib treatment without disease progression, those patients must be switched to brigatinib.
✓. Are postmenopausal for at least 1 year before the screening visit, OR
✓. Are surgically sterile, OR
✓. If they are of childbearing potential, agree to use a highly effective method of contraception from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
Exclusion criteria
✕. Postmenopausal (no menses in greater than or equal to 12 consecutive months).
✕. History of hysterectomy or bilateral salpingo-oophorectomy.
✕. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
✕. History of bilateral tubal ligation or another surgical sterilization procedure.
✕
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: Through study completion; an average of 1 year
. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.