Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer (NCT07415005) | Clinical Trial Compass
RecruitingPhase 2
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
United States30 participantsStarted 2026-04-24
Plain-language summary
This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.
Who can participate
Age range18 Years
SexALL
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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 lorlatinib treatment without disease progression or (c) ≤4 weeks of first line alectinib, brigatinib or ensartinib treatment without disease progression, those patients must be switched to lorlatinib.
✓. Candidate for local consolidation therapy in the opinion of the treating physician.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
✓. Males or females ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lorlatinib in combination with other agents in patients \<18 years of age, children are excluded from this study.
✓. Adequate organ function laboratory values, defined as:
✓. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L or at least 1000/mm3 .Platelet count at least 75,000/mm3 or at least 75 x 109/L
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).
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
✕. History of bilateral tubal ligation or another surgical sterilization procedure.
✕. 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.
✕0. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
✕. Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
✕. Agree to completely abstain from heterosexual intercourse