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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation (AL3810 + carboplatin + etoposide) | Experimental | 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. |
|
| AL3810+ carboplatin + etoposide | Experimental | 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. |
|
| Placebo+ carboplatin + etoposide | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL3810 | Drug | 5mgQD, 7.5mgQD, 10mgQD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II:adverse event(AE)/serious adverse event(SAE) | AE/SAE to find the recommended dose of AL3810 | From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Phase III:1.PFS | 1. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 | From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months |
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Inclusion Criteria:
exclusion criteria: main exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yixing Chen | Contact | + 86-(021)-2056 8989 | 8903 | yixing.chen@haihepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| C000595232 | E-3810 |
| C098534 | EC regimen |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| carboplatin + etoposide | Drug | Carboplatin and etoposide are background treatment. |
|
| Placebo | Drug | Placebo |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |