Neoadjuvant PD-1 Inhibitor (Tislelizumab) Plus Chemotherapy in Patients With Limited-stage Small-cell Lung Cancer: an Open-lable, Single-arm, Phase 2 Trial

Who is this study for? Patients with limited stage small cell lung cancer
What treatments are being studied? BGB-A317+Chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II, non-randomized, open-label, single-center study to evaluate the efficacy and safety of neoadjuvant PD-1 inhibitor (Tislelizumab) + chemotherapy (cisplatin/carboplatin + etoposide) followed by radical surgery and adjuvant Tislelizumab immunotherapy as first-line treatment in patients limited-stage SCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The patient shall sign the Informed Consent Form.

• Aged 18 ≥ years.

• Histological or cytological diagnosis of SCLC by needle biopsy, and 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.):

‣ ANC count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L#hemoglobin

‣ ≥90 g/L;

⁃ the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \< 1.5 times of upper limit of normal (ULN);

⁃ partial thromboplastin time (APTT) ≤1.5×ULN;

⁃ total bilirubin ≤1.5×ULN;

⁃ alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.

• No systemic metastasis;

• Expected to be completely resected;

⁃ Good cardiopulmonary function and can tolerate surgical treatment;

⁃ Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Tislelizumab (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 Tislelizumab (whichever is later).

Locations
Other Locations
China
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Contact Information
Primary
Peng Zhang, MD
zhangpeng1121@outlook.com
+8613512185932
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 15
Treatments
Experimental: LS-SCLC
Induction therapy: Tislelizumab 200mg, i.v., q3w, 4 cycles; cisplatin 75mg/m2, d1-3 or carboplatin AUC5, d1+ etoposide 100mg/m2, q3w, 4 cycles.~Regional therapy: Candidates for complete resection will receive surgery otherwise they will receive radiotherapy.~Adjuvant therapy: Patients received surgery will receive adjuvant Tislelizumab plus platinum-etoposide therapy for four cycles.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pulmonary Hospital, Shanghai, China

This content was sourced from clinicaltrials.gov

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