A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC

Unresectable Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837052
• Other study ID #: CTHLX10
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: July 2023
• Source: Zhejiang University
• Contact: Peng Zhao, MD
• Phone: +86-18767186629
• Email: zhaop[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.

Description:

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer. The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients should voluntarily join this study and sign the informed consent form

2. NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)

3. Patients with IIIB - IVA oligometastatic NSCLC : (a) IIIB - IIIC stage (T1-4N2-3):

patients are not suitable or refuse to receive upfront surgical resection or radiotherapy; (b) oligometastatic stage IV (T1-3N0-2): radical resection/radiotherapy is feasible for metastatic lesions (the number of metastases being up to 3, and the maximum diameter of metastases being up to 2cm)

4. After evaluation by MDT, upfront surgical resection is not the preferred treatment, but after induction systemic treatments, radical resection of the primary tumor is feasible, and radical resection/radiotherapy is feasible for extrathoracic metastases (if any)

5. Age from 18 to 75 years old, both male and female

6. ECOG score 0-1

7. According to the RECIST v1.1 , patients should have at least one measurable lesion

8. For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy

9. According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy

10. The function of important organs should meet the following requirements: absolute count of neutrophils = 1.5 × 109/L; Platelets = 100 × 109/L; Hemoglobin = 90g/L; Serum albumin = 35g/L; Thyroid hormone (TSH) = 1 × ULN; Serum bilirubin = 1.5 × ULN; ALT and AST = 3 × ULN; International standardized ratio (INR) = 1.5 or prothrombin time (PT) = 1.5 × ULN; Serum creatinine = 1.5 × ULN

11. Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period Exclusion Criteria:

Patients who meet any of the following conditions will not be enrolled in this study:

1. NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes

2. Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody

3. Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)

4. Patients with active hepatitis B/C

5. Patients with any active autoimmune diseases or a history of autoimmune diseases

6. Patients who are using immunosuppressive agents or require systemic hormone therapy

7. Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function

8. Patients with abnormal coagulation function (INR>2.0, PT>16s)

9. Arterial/venous thrombotic events occurred before screening within 6 months

10. Patients with active infection

11. Patients with congenital or acquired immune dysfunction (such as HIV infection)

12. According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Unresectable Lung Non-Small Cell Carcinoma

Intervention

Procedure:
• serplulimab plus chemotherapy as conversion treatment
Patients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.

Locations

Country	Name	City	State
China	Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of NSCLC converting to resectable tumors	the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy	up to 16 weeks
Primary	the 1-year progression-free survival (PFS) rate	the proportion of patients who are progression-free after pneumonectomy	up to one year
Secondary	the rate of R0 resection	the proportion of R0 resection in patients who receive pneumonectomy	immediately after the surgery
Secondary	Progression-free survival (PFS)	The duration from the date of initial treatment to the date of disease progression or death due to any cause	up to five years
Secondary	Overall survival (OS)	The duration from the date of initial treatment to the date of death due to any cause	up to five years
Secondary	the rate of major pathological response (MPR)	the proportion of patients who achieve MRP among those receiving pneumonectomy	up to 16 weeks
Secondary	the rate of pathological complete response (pCR)	the proportion of patients who achieve pCR among those receiving pneumonectomy	up to 16 weeks