Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AL8326 tablets

    Drug

    10mg/tablet, Oral administration, once daily.

  • placebo

    Drug

    Oral administration, once daily.

Treatment groups

243 Participants
are divided into 2 treatment groups
Group A: active group（AL8326）Experimental treatment 1 intervention
Group B: Control group（Placebo)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

The time between the date of randomization and the death of the subject from any cause.

Time frame
Cycle 1 Day 1 up to 3 years (each cycle is 28 days)

Secondary outcomes

1

Progression-free survival (PFS)

The period of time between the start of the subject's date of randomization and the first observation of disease progression (based on RECIST 1.1 criteria) or the occurrence of death due to any cause (the earlier of the two occurrences).

Time frame
Cycle 1 Day 1 up to 12 months(each cycle is 28 days)
2

Objective remission rate (ORR)

Proportion of subjects achieving CR and PR according to RECIST 1.1.

Time frame
12 months
3

Duration of remission (DOR)

Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause.

Time frame
12 months
4

Disease Control Rate (DCR)

Proportion of subjects achieving CR, PR, and SD.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Advenchen Laboratories Nanjing Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now