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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benmelstobart in combination with anlotinib and chemotherapy | Experimental | Patients who met the enrollment criteria were first treated with benmelstobart in combination with anlotinib and carboplatin/cisplatin and etoposide for 4 cycles, and for non-progressing patients were evaluated by the investigator to receive maintenance therapy with benmelstobart in combination with anlotinib, which was continued until clinical benefit was lost or toxicity was intolerable or efficacy was evaluated to be PD, or continuation of the medication was deemed unsuitable by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benmelstobart | Drug | Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The time from treatment to the first documented progressive disease (PD) assessed by the investigator according to RECIST 1.1 or death for any reason. Evaluated every 2 cycles/6 weeks on treatment and every 3 months in follow-up. | Approximately 7 months from treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from treatment to death due to any cause. Follow-up visits were made every 3 months after the end of treatment. | Approximately 14 months from treatment. |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
1. Patients with pathologically confirmed extensive stage small cell lung cancer (VALG stage).
2. No prior systemic therapy for extensive-stage small cell lung cancer;
3. Patients who have received prior radiotherapy for limited-stage SCLC must have received radical therapy with a treatment-free interval of at least 6 months between the end of chemotherapy, radiotherapy, or radiochemotherapy and the diagnosis of extensive-stage SCLC (counting the time of completion of the last cycle of chemotherapy/time of completion of the last dose of radiotherapy);
4. The presence of a Measurable lesions as defined by the RECIST 1.1 criteria, where a previously irradiated lesion shows definite progression after radiotherapy and where this previously irradiated lesion is not the only lesion;
5. 18-75 years of age or older; ECOG score: 0-1; expected survival ≥ 3 months.
6. Adequate hematology and organ function, i.e., the following criteria are met:
a) Hematology (no transfusion of blood or blood products within 14 days, not corrected with G-CSF and other hematopoietic stimulating factors): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1,500/mm3); ii. Platelet count (PLT) ≥ 100 × 109/L (100,000 /mm3); iii. Hemoglobin (HB) ≥ 80 g/L.
b) Renal: i. Creatinine clearance* (CrCl) calculated ≥ 50 mL/min; ii. Urine Protein < 2+ or 24 hour (h) urine protein quantification < 1.0 g.
c) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. serum albumin (ALB) ≥ 28 g/L.
d) Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
e) Cardiac Function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
7, Subjects voluntarily enrolled in this study and signed an informed consent form, complied well and cooperated with the follow-up.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Anlotinib | Drug | Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week. During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events. |
|
| Carboplatin or cisplatin | Drug | Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV. |
|
| Etoposide | Drug | Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV. |
|
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR), assessed by the investigator according to RECIST 1.1.
| Approximately 12 weeks after the last participant begin study treatment. |
| Duration of Response (DOR) | The time from the first response (Complete Response (CR) or Partial Response (PR)) to disease progression (PD) assessed by the investigator according to RECIST 1.1 or death for any reason. | Approximately 7 months from treatment. |
| Disease Control Rate (DCR) | Percentage of participants who achieved Complete Response (CR), Partial Response (PR) or Stable Disease (SD), assessed by the investigator according to RECIST 1.1. | Approximately 12 weeks after the last participant begin study treatment. |
| Safety (Adverse Events (AEs)) | Type and severity of adverse events according to CTCAE v5.0; calculation of the incidence of adverse events and their incidence by system. | From enrollment until 30 days after the end of treatment. |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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