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

NCT04542369 | Unknown Phase 2

• 1 other identifier: LungMate-006 (FK-LYIB-001)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Progression-free survival (PFS)

  up to 60 months

• Overall survival (OS)

  up to 63 months

• Health related quality of life (HRQol)

  up to 12 months

• Major pathologic response (MPR)

  up to 5 months

• Objective response rate (ORR)

  up to 4 months

Study Arms (1)

LS-SCLC

EXPERIMENTAL

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.

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

Interventions

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

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

LS-SCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;
• 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;
• With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
• Participants who are allergic to the test drug or any auxiliary materials;
• Have or currently have interstitial lung disease;
• Participants with active HIV;
• Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
• Pregnant or lactating women;
• Any conditions of malabsorption;
• Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
• Other factors that researchers think it is not suitable for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Peng Zhang, MD

CONTACT

+8613512185932; zhangpeng1121@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of science and education department

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: November 30, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

CN (1)