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

NCT ID: NCT05837052

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-12-30

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.

Detailed 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.

Conditions

Unresectable Lung Non-Small Cell Carcinoma

Study Design

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

Study Groups

Serplulimab plus chemotherapy

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.

Group Type: EXPERIMENTAL

serplulimab plus chemotherapy as conversion treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Weijia Fang, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weijia Fang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Zhao, MD

Role: CONTACT

zhaop@zju.edu.cn

+86-18767186629

Jian Hu, MD

Role: CONTACT

dr_hujian@zju.edu.cn

+86-18767186629

Facility Contacts

Lulu Liu

Role: primary

weijiafang@zju.edu.cn

Other Identifiers

CTHLX10

Identifier Type: -

Identifier Source: org_study_id