Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05549037

Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC

Led by Hunan Province Tumor Hospital · Updated on 2025-02-19

210

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to explore time-of-day of administration of immunochemotherapy on the efficacy for treatment naive advanced non-small cell lung cancer.

CONDITIONS

Official Title

Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand the trial and provide signed informed consent
  • Age 18 years or older
  • Confirmed advanced non-small cell lung cancer by biopsy or cytology with local progression or metastasis
  • Negative for EGFR, ALK, and ROS1 mutations
  • ECOG performance status of 0 or 1
  • Expected survival of at least 12 weeks
  • Adequate bone marrow and organ function
  • Measurable tumor lesions according to RECIST 1.1
  • Stable brain metastases allowed
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for advanced or metastatic disease
  • Treatment with chemotherapy or targeted antibodies within 4 weeks before study drug
  • Radiation therapy within 14 days before study drug or unresolved radiation toxicity
  • Spinal cord compression or meningeal metastasis
  • Other cancers within 2 years
  • Severe side effects from prior treatments above grade 1 (except hair loss)
  • Stroke or brain hemorrhage within 6 months
  • Severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding
  • Active infections such as hepatitis B, hepatitis C, HIV, or COVID-19
  • Heart diseases or abnormalities
  • Past or active interstitial lung disease or immune-related pneumonia
  • Severe nausea, vomiting, swallowing difficulties, or poor drug absorption
  • Live vaccines within 2 weeks before starting study drug
  • Pregnant or breastfeeding women
  • Allergy to study drugs or ingredients
  • Any other conditions deemed unsuitable by the investigator

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

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

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Research Team

Y

Yongchang C Zhang, MD

CONTACT

Y

Yongchang Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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