Clinical trial · Observational
The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China
A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer (NSCLC) in China
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung Cancer (NSCLC) who received ALK-TKIs as first-line treatment. Approximately 800 patients with ALK-positive locally advanced or metastatic NSCLC will be enrolled in this study. This study has 3 parallel cohorts which are listed below. Patient-reported outcome data will be collected using the following instruments: EORTC QLQ-C30, EORTC QLQ-LC13, selected items from the PRO-CTCAE, EORTC-IL46.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-reported outcome | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort I
- description
- 400 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Alectinib
- interventionNames
- Other: Patient-reported outcome
- label
- Cohort II
- description
- 200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Lorlatinib
- interventionNames
- Other: Patient-reported outcome
- label
- Cohort III
- description
- 200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with other ALK-TKIs except for Alectinib and Lorlatinib
- interventionNames
- Other: Patient-reported outcome
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have signed the informed consent form (ICF) as per local regulations * Female or male aged 18 years or older * Ability to comply with the study protocol, in the judgment of the investigator * Life expectancy ≥ 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2 * Have a confirmed diagnosis of locally advanced or metastatic NSCLC on or after the date of local approval for ALK-TKIs as first-line monotherapy regimen for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study * ALK positive as determined by Ventana immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), reverse transcription polymerase chain reaction(RT-PCR) and next generation sequencing (NGS), documented prior to receiving treatment with an ALK inhibitor * Planned to receive, treatment for ALK-positive advanced NSCLC with ALK-TKIs * Able to be followed up at the participating site * Patients with advanced NSCLC who have asymptomatic central nervous system (CNS) metastases are eligible for inclusion Exclusion Criteria: * Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC * Patients participating in clinical trials within 28 days prior to initiation of study treatment * Pregnant, lactating, or breastfeeding women
References
Publications (0)
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