Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06371482

Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01)

Led by Hebei Medical University Fourth Hospital · Updated on 2024-06-17

58

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer.

CONDITIONS

Official Title

Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation and signed informed consent
  • Age 18 to 75 years, any gender
  • Confirmed limited-stage small cell lung cancer without distant metastasis
  • Immunohistochemical results available
  • Chemotherapy includes cisplatin or carboplatin combined with etoposide
  • ECOG performance status of 0 or 1
  • Weight over 40 kg
  • Expected survival of at least 6 months
  • At least one measurable lesion suitable for repeated assessment by CT or MRI
  • No previous immunotherapy
  • Adequate blood counts, liver, kidney, heart, lung function, and coagulation within specified limits
  • Female participants must be postmenopausal or have a negative pregnancy test if premenopausal
Not Eligible

You will not qualify if you...

  • Distant organ metastases excluding supraclavicular lymph nodes
  • Prior chest radiotherapy
  • Contraindications to etoposide-platinum chemotherapy
  • Active or history of autoimmune disease or recent immunosuppressive drug use
  • Prior or current PD-1/PD-L1 immunotherapy or participation in other interventional studies
  • Recent anti-tumor or long-term systemic immunotherapy or hormone therapy within 4 weeks
  • Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
  • Immune deficiencies such as HIV, active hepatitis B or C, or active tuberculosis
  • Active infection or unexplained fever over 38.5°C within 2 weeks before screening
  • Other serious illnesses or conditions that may interfere with study participation 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

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050011

Actively Recruiting

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Research Team

W

Wenbin Shen, PhD

CONTACT

H

Hesong Wang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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