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

NCT05837052 | Recruiting Phase 2

• 1 other identifier: CTHLX10
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Lung Non-Small Cell Carcinoma

Keywords

Unresectable NSCLC; Serplulimab; Conversion treatment

Outcome Measures

Primary Outcomes (2)

• 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

• the 1-year progression-free survival (PFS) rate

  the proportion of patients who are progression-free after pneumonectomy

  up to one year

Secondary Outcomes (5)

• the rate of R0 resection

  immediately after the surgery

• Progression-free survival (PFS)

  up to five years

• Overall survival (OS)

  up to five years

• the rate of major pathological response (MPR)

  up to 16 weeks

• the rate of pathological complete response (pCR)

  up to 16 weeks

Study Arms (1)

Serplulimab plus chemotherapy

EXPERIMENTAL

Patients with unresectable NSCLC will receive 3-4 cycles of serplulimab plus chemotherapy as the conversion treatment (serplulimab 300mg d1 q3w; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for adenocar- cinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), 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. Maintenance treatment with PD-1 antibody q3w will continue up to 12 months or disease progression after surgery.

Procedure: serplulimab plus chemotherapy as conversion treatment

Interventions

serplulimab plus chemotherapy as conversion treatment PROCEDURE

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.

Serplulimab plus chemotherapy

Eligibility Criteria

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

You may qualify if:

• Patients should voluntarily join this study and sign the informed consent form
• NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)
• 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)
• 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)
• Age from 18 to 75 years old, both male and female
• ECOG score 0-1
• According to the RECIST v1.1 , patients should have at least one measurable lesion
• 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
• According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
• 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
• 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

You may not qualify if:

• Patients who meet any of the following conditions will not be enrolled in this study:
• NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes
• Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody
• Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)
• Patients with active hepatitis B/C
• Patients with any active autoimmune diseases or a history of autoimmune diseases
• Patients who are using immunosuppressive agents or require systemic hormone therapy
• Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function
• Patients with abnormal coagulation function (INR\>2.0, PT\>16s)
• Arterial/venous thrombotic events occurred before screening within 6 months
• Patients with active infection
• Patients with congenital or acquired immune dysfunction (such as HIV infection)
• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 310058, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Weijia Fang, MD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Zhao, MD

CONTACT

+86-18767186629; zhaop@zju.edu.cn

Jian Hu, MD

CONTACT

+86-18767186629; dr_hujian@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: May 15, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)