CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 126 target
Drug / intervention
Loratinibdrug
Likely dose
Loratinib 100mgfrom record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed ALK-positive NSCLC (Stage IIIB/C not amenable for multimodality treatment or Stage IV)
  • ✓ALK status determined by Ventana ALK (D5F3) IHC, FISH, PCR, NGS, or ctDNA
  • ✓At least 1 extracranial measurable target lesion per RECIST v. 1.1 not previously irradiated
  • ✓Age ≥18 years
Key exclusion· 19
  • ✕Prior systemic treatment for advanced/metastatic NSCLC including ALK TKIs, angiogenesis inhibitors, immunotherapy, or chemotherapy (prior treatment for earlier stages allowed if >12 months prior)
  • ✕Spinal cord compression unless good pain control and neurological stabilization for ≥4 weeks prior to randomization
  • ✕Major surgery within 4 weeks prior to randomization
  • ✕Radiation therapy within 2 weeks prior to randomization, whole brain irradiation within 4 weeks prior, or palliative CNS radiation within 48 hours prior

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06092086
NCT06092086Phase 2RecruitingUpdate OverdueUpdated 32mo ago · Completion was 11mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in The First-Line Treatment of Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer

Guangdong Association of Clinical Trials·interventional·Posted Oct 23, 2023·Updated Oct 23, 2023

In Brief

A Phase 2 clinical trial evaluating Loratinib for ALK Positive Non-small Cell Lung Cancer. Currently recruiting, targeting 126 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALK Positive Non-small Cell Lung Cancer
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027202820292030
First PostedOct 23, 2023
Enrollment StartAug 18, 2023
Primary CompletionAug 1, 2025
Study CompletionAug 1, 2030
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 2.7 years ago

Interventions

Loratinibdrug

Continuous daily PO dosing of lorlatinib 100mg QD.