This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients

Haihe Biopharma

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Extensive-stage Small Cell Lung Cancer

Treatments: Drug: carboplatin + etoposide; Drug: Placebo; Drug: AL3810

Study type: Interventional

Funder types: Industry

Identifiers

NCT04254471

AL3810-301

Details and patient eligibility

About

Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.

Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.

Enrollment: 313 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Signed Informed Consent Form
• Male or female, 18 ~75years of age
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
• Histologically or cytologically confirmed ES-SCLC
• No prior treatment for ES-SCLC
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function.
• Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.

exclusion criteria: main exclusion criteria

• Histologically confirmed mixed small cell lung cancer.
• Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
• Uncontrolled hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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313 participants in 3 patient groups, including a placebo group

Dose escalation (AL3810 + carboplatin + etoposide)

Experimental group

Description:

Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.

Treatment:

Drug: AL3810

Drug: carboplatin + etoposide

AL3810+ carboplatin + etoposide

Experimental group

Description:

Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.

Treatment:

Drug: AL3810

Drug: carboplatin + etoposide

Placebo+ carboplatin + etoposide

Placebo Comparator group

Description:

Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.

Treatment:

Drug: Placebo

Drug: carboplatin + etoposide