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OncoMatch/Clinical Trials/NCT06247605

A Phase IIII Study of AL8326 in Small Cell Lung Cancer

Is NCT06247605 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies AL8326 tablets for small cell lung carcinoma.

Phase 3RecruitingAdvenchen Laboratories Nanjing Ltd.NCT06247605Data as of Jun 2026Location: China

Treatment: AL8326 tabletsThis 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.

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Extracted eligibility criteria

Treatments studied

Other

AL8326 tablets

Cancer type

Small Cell Lung Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Must have received: platinum-based chemotherapy — first-line

including first-line platinum-based therapy

Cannot have received: (AL8326)

Having previously used AL8326 tablets

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L (1500/mm3), platelets ≥ 80 × 10^9/L, hemoglobin ≥ 9.0 g/dL

Kidney function

Serum creatinine ≤ 1.5 × ULN and estimated creatinine clearance rate ≥ 60 ml/min by Cockcroft-Gault formula

Liver function

serum total bilirubin ≤ 1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN (no liver mets), ≤ 5 × ULN (with liver mets)

Cardiac function

Left ventricular ejection fraction (LVEF) > 50% at screening

adequate organ and bone marrow function and meets the following laboratory criteria: ... see details above

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06247605 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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