Pilot Study of PD-1inhibitor (Tislelizumab) Plus Chemotherapy as Neoadjuvant Therapy for Limited-Stage Small-Cell Lung Cancer

NCT ID: NCT04542369

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2025-11-30

Brief 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.

Conditions

Small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)

Intervention Type: DRUG

Inductive/neoadjuvant therapy: Tislelizumab + EP Maintenance/adjuvant therapy: Tislelizumab + EP

Interventions

Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)

Inductive/neoadjuvant therapy: Tislelizumab + EP Maintenance/adjuvant therapy: Tislelizumab + EP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The patient shall sign the Informed Consent Form.

2. Aged 18 ≥ years.

3. Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage (local advanced) confirmed by imageological examinations.

4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.

5. Life expectancy is at least 12 weeks.

6. At least 1 measurable lesion according to RECIST 1.1.

7. 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.

8. No systemic metastasis;

9. Expected to be completely resected;

10. Good cardiopulmonary function and can tolerate surgical treatment;

11. 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.

12. 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).

Exclusion Criteria

1. Participants who have received any systemic anti-cancer treatment for SCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;

2. Participants with cancer other than SCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;

3. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;

4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;

5. Participants who are allergic to the test drug or any auxiliary materials;

6. Have or currently have interstitial lung disease;

7. Participants with active HIV;

8. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;

9. Pregnant or lactating women;

10. Any conditions of malabsorption;

11. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;

12. Other factors that researchers think it is not suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Peng Zhang

Director of science and education department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Zhang, MD

Role: CONTACT

zhangpeng1121@outlook.com

+8613512185932

Facility Contacts

Peng Zhang, PhD

Role: primary

zhangpeng1121@tongji.edu.cn

021-55672180

Other Identifiers

LungMate-006 (FK-LYIB-001)

Identifier Type: -

Identifier Source: org_study_id