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This is a non-randomized, open-label, single-center, phase II trial to evaluate the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy as first-line treatment in patients limited-stage SCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LS-SCLC Surgery | Experimental | Induction therapy: TQB2450 1200mg, d1+carboplatin (AUC5) , d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 4 cycles. Surgery (decided by MDT) Maintenance therapy: Etoposide,100 mg/m2 , d1-3 + Carboplatin,AUC5 (ivgtt, q3w,Two cycles) + TQB24501200mg, d1 (ivgtt, q3w, 1 Year) or progression disease, or other discontinuation criteria (intolerant toxicity, no more clinical benefit, receiving another anti-tumor regimen [except radiotherapy], withdrawal of informed consent or death). |
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| LS-SCLC Radiotherapy | Experimental | Induction therapy: TQB2450 1200mg, d1+carboplatin (AUC5) , d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 4 cycles. Radiotherapy (decided by MDT) Maintenance therapy: Etoposide,100 mg/m2 , d1-3+Carboplatin,AUC5 (ivgtt, q3w,Two cycles)+TQB24501200mg, d1(ivgtt, q3w, 1 Year) or progression disease, or other discontinuation criteria (intolerant toxicity, no more clinical benefit, receiving another anti-tumor regimen [except radiotherapy], withdrawal of informed consent or death). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 | Drug | Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year) |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the inductive/neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed. | up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | It refers to the time from the first administration of TQB2450 in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression. | up to 60 months |
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Inclusion Criteria:
The patient shall sign the Informed Consent Form.
Aged 18 ≥ years.
Histological or cytological diagnosis of SCLC by needle biopsy, and extensive stage or limited stage (local advanced) confirmed by imageological examinations.
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
Life expectancy is at least 12 weeks.
At least 1 measurable lesion according to RECIST 1.1.
Patients with good function of other main organs (liver, kidney, blood system, etc.):
Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Zhang, MD | Contact | +8613512185932 | zhangpeng1121@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
The researchers will consider whether IPD is available to other researchers only after the paper is published
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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 |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy in treating limited-stage small-cell lung cancer
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| TQB2450 | Drug | Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year) |
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| Progression-free survival (PFS) | It refers to the time from the first administration of TQB2450 in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression. | up to 60 months |
| Disease-free survival (DFS) | It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring). | up to 60 months |
| Overall survival (OS) | It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | up to 63 months |
| Major pathologic response (MPR) | MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery. | up to 5 months |
| Safety: frequency of severe adverse events | The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first. | up to 18 months |
| Health related quality of life (HRQol) | The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality. | up to 12 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 |