Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05837052

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

Led by Zhejiang University · Updated on 2023-07-17

49

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients voluntarily agree to participate and sign informed consent
  • Diagnosed NSCLC by cytology or histology, no prior anti-tumor treatments
  • Stage IIIB - IVA oligometastatic NSCLC: (a) IIIB - IIIC (T1-4N2-3) unsuitable or refusing upfront surgery/radiotherapy; (b) oligometastatic IV (T1-3N0-2) with up to 3 metastases, each ≤ 2 cm, suitable for radical resection/radiotherapy
  • After multidisciplinary team evaluation, upfront surgery not preferred but radical resection feasible after induction treatment
  • Age between 18 and 75 years, any gender
  • ECOG performance status 0-1
  • At least one measurable lesion per RECIST v1.1
  • Suspicious mediastinal lymph nodes require pathological diagnosis by biopsy or surgery
  • Lung function adequate for pneumonectomy (e.g., FVC, FEV1, TLC, FRC, DLco)
  • Adequate organ function including neutrophils ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, hemoglobin ≥ 90g/L, serum albumin ≥ 35g/L, thyroid hormone ≤ 1× ULN, bilirubin ≤ 1.5× ULN, ALT/AST ≤ 3× ULN, INR or PT ≤ 1.5× ULN, serum creatinine ≤ 1.5× ULN
  • Women of childbearing age and men with partners of childbearing age must use effective contraception during the trial
Not Eligible

You will not qualify if you...

  • Presence of sensitive EGFR mutations, EML4-ALK fusion, or other ALK gene alterations
  • Prior treatment with immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 antibodies)
  • Other primary cancers within past 3 years (except cured skin basal cell carcinoma or cervical carcinoma in situ)
  • Active hepatitis B or C infection
  • Active or history of autoimmune diseases
  • Use of immunosuppressive or systemic hormone therapy
  • Poorly controlled hypertension or cardiac function issues
  • Abnormal blood clotting (INR > 2.0, PT > 16s)
  • Arterial or venous thrombosis within 6 months before screening
  • Active infections
  • Congenital or acquired immune deficiency (e.g., HIV infection)
  • Other factors judged by researchers to affect study results or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhejiang University

Hangzhou, Zhejiang, China, 310058

Actively Recruiting

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Research Team

P

Peng Zhao, MD

CONTACT

J

Jian Hu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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