Clinical Study of PD-1 Antibody (BGB-A317) Plus Chemotherapy (Cisplatin and Etoposide) for Limited Stage Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04542369|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer||Drug: BGB-A317 Plus Chemotherapy (Cisplatin and Etoposide)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of PD-1 Antibody (BGB-A317) Plus Chemotherapy (Cisplatin and Etoposide) for Limited Stage Small Cell Lung Cancer|
|Estimated Study Start Date :||January 31, 2021|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||November 30, 2025|
Induction therapy: BGB-A317 200mg, qd, ivgtt, 2-4 cycles; cisplatin 75mg/m2, d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 2-4 cycles. Maintenance therapy: BGB-A317 200mg, qd, ivgtt, thereafter until 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).
Drug: BGB-A317 Plus Chemotherapy (Cisplatin and Etoposide)
Inductive/neoadjuvant therapy: BGB-A317 + EP Maintenance/adjuvant therapy: BGB-A317
- Safety: frequency of severe adverse events [ Time Frame: up to 18 months ]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.
- Progression-free survival (PFS) [ Time Frame: up to 60 months ]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.
- Overall survival (OS) [ Time Frame: up to 63 months ]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.
- Health related quality of life (HRQol) [ Time Frame: up to 12 months ]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.
- Major pathologic response (MPR) [ Time Frame: up to 5 months ]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.
- Objective response rate (ORR) [ Time Frame: up to 4 months ]
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.
- Disease-free survival (DFS) [ Time Frame: up to 60 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542369
|Contact: Peng Zhang, MDfirstname.lastname@example.org|