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| ID | Type | Description | Link |
|---|---|---|---|
| NeoSCLC-001 | Other Identifier | Beijing Chest Hospital, Capital Medical University |
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This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoCIT | Experimental | Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab |
|
| neoCT | Active Comparator | Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | administered via Intravenous (IV) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) Rate | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to 3 months following completion of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response (MPR) Rate | MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy. | Up to 3 months following completion of neoadjuvant treatment |
| Event-Free Survival (EFS) |
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Inclusion Criteria:
Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
The age range was 18 to 75 years, with no gender restriction.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
Life expectancy was estimated to be at least 3 months.
No previous anti-tumor treatment specifically for SCLC was administered.
According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.
Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:
Patients of childbearing potential must agree to use contraception.
Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Shi, MD | Contact | +8613488787767 | shiliang@ccmu.edu.cn |
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The researchers will consider whether IPD is available to other researchers only after the paper is published
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| Carboplatin injection |
| Drug |
administered via IV injection |
|
| Cisplatin injection | Drug | administered via IV injection |
|
| Etoposide injection | Drug | administered via IV injection |
|
EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. |
| up to 5 years |
| Overall Survival (OS) | OS is defined as the time from enrollment until death from any cause. | up to 5 years |
| Objective response rate (ORR) | The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed. | Up to 1 months following completion of neoadjuvant treatment |
| 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 6 months |
| 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 |
|---|---|
| C000707970 | tislelizumab |
| 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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