Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 \*\*;

• Expected survival time of at least 12 weeks;

• ECOG (PS) score of 0 to 2;

• Subject has adequate organ and bone marrow function and meets the following laboratory criteria:

‣ Blood routine test (without red blood cell or platelet transfusion or hematopoietic factor drug correction within 14 days before screening): absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (1500/mm3), platelets ≥ 80 × 10\^9/L; hemoglobin ≥ 9.0 g/dL;

⁃ Liver function: serum total bilirubin ≤ 1.5 × ULN (upper limit of normal), except for patients with Gilbert 's syndrome (persistent or recurrent hyperbilirubinemia, manifested as unconjugated bilirubin elevation in the absence of hemolysis or pathological evidence of liver); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for patients without liver metastasis, and ALT and AST ≤ 5 × ULN for patients with liver metastasis;

⁃ Renal function: Serum creatinine ≤ 1.5 × ULN and estimated standard cendogenous creatinine clearance rate ≥ 60 ml/min by Cockcroft-Gault formula, Ccr (ml/min) = \[(140-age) × body weight (kg)\]/\[72 × Scr (mg/dl)\], calculated for females × 0.85;

⁃ Coagulation function: international normalized ratio (INR) ≤ 1.5;

⁃ Left ventricular ejection fraction (LVEF) \> 50% at screening. 8.1) Female: For female subjects of childbearing potential, they must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically approved method of contraception (condom, sponge, gel, diaphragm, IUD, oral or injectable contraceptive, subcutaneous implant, etc.) during and for 3 months after treatment; they must be non-pregnant and lactating. Female subjects are considered fertile if they are menopausal but have not reached post-menopausal status (menopause of 12 consecutive months or more, with no cause other than menopause) and have not undergone sterilization (removal of ovaries and/or uterus). Their sexual partner agrees to use a medically licensed method of contraception during the subject's treatment and for 3 months after completion; 2) Males: surgical sterilization or agreement to use medically licensed contraception during and for 3 months after the end of treatment; their sexual partners agree to use medically licensed contraception during and for 3 months after the end of the subject's treatment;

∙ 9\. Capable and willing to comply with protocol requirements during the study and subsequent procedures.

Locations
Other Locations
China
JILIN Cancer Hospital
RECRUITING
Changchun
Contact Information
Primary
yingyin Li
anne@advenchen.com.cn
+8657188683590
Backup
Huaqing He
huaqingh@advenchen.com.cn
+8615205140516
Time Frame
Start Date: 2023-10-26
Estimated Completion Date: 2029-07
Participants
Target number of participants: 243
Treatments
Experimental: active group(AL8326)
Oral AL8326 (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles).
Placebo_comparator: Control group(Placebo)
Oral placebo (28-day cycle, once daily) until confirmation of disease progression, intolerable toxicity or death, voluntary withdrawal from the study, for a total of no more than 12 months (approximately 13 cycles).
Sponsors
Leads: Advenchen Laboratories Nanjing Ltd.

This content was sourced from clinicaltrials.gov

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