NSCLC
Conditions
Brief summary
The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with Iruplinalkib or planned to receive Iruplinalkib treatment in real-world clinical practice.
Interventions
None listed
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed patients with locally-advanced or metastatic ALK-positive non-small cell lung cancer. * Currently receiving, or planned to receive treatment with Iruplinalkib. * Subjects had imaging reports of chest and abdominal enhanced CT and brain MRI within 42 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer. * Subjects had routine and biochemical reports within 30 days prior to the first dose of Iruplinalkib as 1L treatment for locally-advanced or metastatic ALK-positive non-small cell lung cancer.
Exclusion criteria
* Patients who had previously been treated with ALK-TKI, but who had previously only been treated with ALK-TKI as neoadjuvant and/or adjunctive treatment could be enrolled. * Mental disorder or inability to cooperate with examination or follow-up. * Women known to be pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse drug reactions in the overall population | At enrollment and every 3 months thereafter (up to 3 years) |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of greater than or equal to grade 3 AEs, SAEs, AEs resulting in dose reduction/interruption/discontinuation, AESIs, and AEs resulting in death in the overall population | At enrollment and every 3 months thereafter (up to 3 years) |
| Real-world progression-free survival (rwPFS) for 1L treatment with Iruplinalkib | From the first administration of Iruplinalkib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 3 years). |
| Time to treatment failure (TTF) for 1L treatment with Iruplinalkib | From the first administration of Iruplinalkib to the date of first documentation of discontinuation of Iruplinalkib due to any cause (up to 3 years). |
| Event to first follow-up treatment or death (TFST) for 1L treatment with Iruplinalkib | From the first administration of Iruplinalkib to the date of first documentation of initiation of next line of treatment, or death due to any cause, whichever occurs first (up to 3 years). |
Contacts
Primary ContactCaiCun Zhou, PhD
Backup ContactWei Li, PhD
Outcome results
None listed