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A multicenter single-arm phase II interventional study to evaluate the activity and safety of the combination of Platinum-Pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib
EU CTIS ID: 2023-506714-43-00
What this study is testing
To compare PFS between patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3.2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained, and documented according to the local regulatory requirements
- Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC
- For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 14 weeks after the last dose of study drugs
- Age at the time of signing the informed consent at least 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC. ALK positivity can be determined by fluorescence in situ hybridization assay (FISH), immunohistochemistry (IHC) or DNA-based next-generation sequencing (NGS)
You likely can't join if
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol
- Diagnosis of any secondary malignancy within the last 3 years, except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
- Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination
- Presence of toxicities contraindicating the continuation of therapy with Lorlatinib
- Concomitant use of potent CYP3A4/5 inducers
See the full eligibility criteria
Who can join
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained, and documented according to the local regulatory requirements
- Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC
- For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 14 weeks after the last dose of study drugs
- Age at the time of signing the informed consent at least 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC. ALK positivity can be determined by fluorescence in situ hybridization assay (FISH), immunohistochemistry (IHC) or DNA-based next-generation sequencing (NGS)
- Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI)
- patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies. If a patient has already received platinum (e.g. in adjuvant setting), the eligibility for PT-pem chemotherapy treatment is at the Investigator discretion
- Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as: • Absence of CNS metastasis • CNS metastasis stable on Lorlatinib and/or stereotactic brain irradiation (SBRT) • Prior radiotherapy must have been completed within 4 weeks of study entry; SBRT must have been completed at least 4 weeks before study entry; and whole-brain radiotherapy at least 4 weeks before study entry. • Patients with previously treated brain metastases are eligible provided they have been clinically stable for at least 4 weeks with no evidence of new or expanding brain metastases
- Adequate organ function (kidney, bone marrow and liver): - Hematology • Absolute Neutrophil Count (ANC) ≥1.5 x 109 / L • Platelets ≥100 x 109 / L • Hemoglobin ≥10 g/dL (≥6.2 mmol/L) - Hepatic function • Total bilirubin <1.25x UNL. In presence of a documented history of Gilbert syndrome the total bilirubin level must be <3.0x UNL • AST and ALT ≤1.5x UNL. If the liver has tumor involvement AST and ALT must be ≤5x UNL • Alkaline phosphatase ≤2.5x UNL - Renal Function • <1.25x ULN creatinine • Creatinine clearance ≥45 ml/min (according to Cockroft-Gault, if creatinine is above UNL)
- If feasible, fresh tissue biopsy demonstrating ALK translocation still present (obtained ≤ 3 months before study enrolment), assessed by local laboratory
What rules you out
- Known hypersensitivity reaction to one of the compounds or substances used in this protocol
- Diagnosis of any secondary malignancy within the last 3 years, except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
- Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination
- Presence of toxicities contraindicating the continuation of therapy with Lorlatinib
- Concomitant use of potent CYP3A4/5 inducers
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.