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This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Induction phase:participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase:participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first. | Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is defined as the time from the initiation of maintenance therapy to the date of death from any cause. | Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months) |
| Objective Response Rate (ORR) |
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Inclusion Criteria for the Induction Phase:
Exclusion Criteria for the Induction Phase:
Inclusion Criteria for the Maintenance Phase:
Exclusion Criteria for the Maintenance Phase:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Liu, MD | Contact | +0086 186 8838 0929 | mingliu128@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| chengzhi Zhou, MD | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Guangzhou medical university | Recruiting | Guangzhou | Guangdong | 51000 | China |
Individual participant data (IPD) will not be shared
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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 |
|---|---|
| C568606 | PM 01183 |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Lurbinectedin | Drug | Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase. |
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| Carboplatin | Drug | Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
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| Etoposide | Drug | Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
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Objective response rate (ORR) is defined as the proportion of participants with a complete response(CR) or partial response(PR) according to RECIST v1.1. |
| up to approximately 24 months |
| Duration of Response (DOR) | Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. | up to approximately 24 months |
| Percentage of Participants With Adverse Events | Percentage of participants with adverse events | up to approximately 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |