A Phase IIII Study of AL8326 in Small Cell Lung Cancer
ConditionSmall Cell Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvenchen Laboratories Nanjing Ltd.
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.
Eligibility criteria
Qualifiers
All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;
Age ≥ 18 years, male or female;
Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies *);
At least one measurable tumor lesion according to RECIST 1.1 **;
Disqualifiers
Known uncontrollable hypersensitivity to AL8326 similar compounds;
Having previously used AL8326 tablets;
Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);
Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;
Trial design
Treatments tested in this trial
- AL8326 tablets
- placebo
Treatment groups
243 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov