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New treatment option for Advanced Non-Small Cell Lung Cancer
Official title Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07415005
What this study is testing
What is Lorlatinib?
Lorlatinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced non-small cell lung cancer.
Also referred to as Lorbrena.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all the following criteria to be included in this study:
- 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
- people 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...
- Candidate for local consolidation therapy in the opinion of the treating physician.
You likely can't join if
- people who meet any of the following criteria will be excluded from this study:
- Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in...
- Previously received any prior TKI, including ALK-targeted TKIs. Note: on-going first line alectinib, brigatinib, lorlatinib and ensartinib use as...
- Previously received more than 1 cycle of chemotherapy +/-immunotherapy for locally advanced or metastatic disease.
- Symptomatic CNS metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not...
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and...
See the full eligibility criteria
Who can join
- people must meet all the following criteria to be included in this study:
- 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
- people 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...
- 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
- Hemoglobin (Hb) at least 9 g/dL (or 5.69 mmol/L) at baseline
- Serum creatinine ≤ 1.5 × ULN or ≥ 45mL/minute creatinine clearance for people with creatinine levels \> 1.5 × the institutional ULN
- Serum total bilirubin less than or equal to ≤ 1.5 × ULN or direct bilirubin ≤ ULN for people with total bilirubin levels \> 1.5 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN except for people with liver metastases for whom ALT and AST should be ≤ 5× ULN
- International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of...
- Activated PTT (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulant
- Female patients of childbearing potential must have a negative pregnancy test documented at time of screening.
- Female patients who:
- 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...
- 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.
- 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...
- 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
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lorlatinib administration.
- Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 milliseconds (msec) in males or ≤470 msec in females.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- people who meet any of the following criteria will be excluded from this study:
- Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients...
- Previously received any prior TKI, including ALK-targeted TKIs. Note: on-going first line alectinib, brigatinib, lorlatinib and ensartinib use as specified in the Inclusion criteria is allowed.
- Previously received more than 1 cycle of chemotherapy +/-immunotherapy for locally advanced or metastatic disease.
- Symptomatic CNS metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted.
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
- The presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis at screening.
- Have a known or suspected hypersensitivity to lorlatinib or its excipients.
- Have malabsorption syndrome or other gastrointestinal (GI) illness or condition that could affect oral absorption of the study drug.
- Have uncontrolled hypertension. Patients with hypertension as defined by current standard of practice should be under treatment on study entry to control blood pressure.
- Received radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.
- Had major surgery within 30 days of enrollment. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.
- Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following: a) Myocardial infarction within 6 months before enrollment. b) Unstable angina within 6...
- Had a cerebrovascular accident within 6 months before first dose of study drug.
- Have an ongoing or active infection, including the requirement for intravenous antibiotics.
- people should not receive other anti-cancer agents (e.g., chemotherapy, immunotherapy, biologic therapy, and/or hormone therapy other than for replacement or appetite stimulant) while on treatment in this study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lorlatinib.
- Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.
- Pregnant women are excluded from this study because lorlatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.