Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials
About this trial
This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC). Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Study Population: Patients with histologically or cytologically confirmed diagnosis of locally advanced [(Stage IIIB/C not amenable for multimodality treatment) or metastatic (Stage IV) by American Joint Committee on Cancer (AJCC) v 7.0] ALK-positive NSCLC where ALK status is determined by the Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC test performed on the Ventana ULTRA or XT Platforms, FISH, PCR, or next generation sequencing (NGS), or circulating tumor DNA (ctDNA).
Either untreated and not currently requiring corticosteroid treatment, or on a stable or decreasing dose of ≤10 mg QD prednisone or equivalent; or
Local treatment has been completed with full recovery from the acute effects of radiation therapy or surgery prior to randomization, and if corticosteroid treatment for these metastases has been withdrawn for at least 4 weeks with neurological stability; or
In case of leptomeningeal disease (LMD) or carcinomatous meningitis (CM) if visualized on magnetic resonance imaging (MRI), or if baseline CSF positive cytology is available.
Disqualifiers
Spinal cord compression unless the patient has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks prior to randomization.
Major surgery within 4 weeks prior to randomization. Minor surgical procedures (e.g., port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Patients who complete whole brain irradiation within 4 weeks prior to randomization or palliative radiation therapy outside of the CNS within 48 hours prior to randomization will also not be included in the study.
Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes.
Trial design
Design model
Single group
Treatments tested in this trial
Loratinib
DrugContinuous daily PO dosing of lorlatinib 100mg QD.
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: CROWN Criteria (CC) Cohort、Compassionate use (CU) CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
Progression Free Survival (PFS) is defined as the time from start of lorlatinib treatment to the date of disease progression as defined by RECIST v1.1 per investigator review or death due to any cause, whichever occurred first.
Time frame
From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 3 years.2
Resistance mechanism of lorlatinib
Resistance mechanism of first-line lorlatinib treatment by tumor tissue, and peripheral blood ctDNA (circulating tumor Deoxyribonucleic acid) biomarkers including, but not limited to, ALK gene rearrangement and/or ALK kinase domain mutations as measured by next-generation sequencing (NGS);
Time frame
From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 3 years.Sponsors and contacts
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Source ClinicalTrials.gov