Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04322578

Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC

Led by Hunan Province Tumor Hospital · Updated on 2024-06-04

120

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to explore the efficacy and safety of Crizotinb or Standard Chemotherapy in Met exon 14 skipping Advanced Non-small Cell Lung Cancer

CONDITIONS

Official Title

Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and agree to the clinical trial requirements by signing informed consent
  • Age 18 years or older
  • Confirmed locally advanced or metastatic non-small cell lung cancer without prior systemic treatment
  • MET exon 14 skipping confirmed by an accredited laboratory
  • ECOG performance status of 0 or 1
  • Predicted survival of at least 12 weeks
  • Adequate bone marrow and organ function
  • Presence of measurable lesions based on RECIST 1.1 criteria
  • Stable brain metastases allowed
Not Eligible

You will not qualify if you...

  • Received prior systemic therapy for locally advanced or metastatic disease
  • Treatment with EGFR or VEGFR antibodies within 4 weeks before starting study drug
  • Radiation therapy within 14 days prior to first dose or unresolved radiation toxicity
  • Use of strong CYP1A2, CYP3A inhibitors or inducers within 1-2 weeks before first dose
  • Presence of spinal cord compression or meningeal metastasis
  • History of other cancers within past 2 years
  • Severe adverse events from prior treatments greater than grade 1 (except hair loss)
  • Stroke or brain hemorrhage within 6 months prior to first dose
  • Severe or uncontrolled systemic diseases including hypertension and active bleeding
  • Persistent or active infections including hepatitis B, hepatitis C, HIV, or COVID-19
  • Heart diseases or abnormalities
  • History of interstitial lung disease or related lung conditions requiring steroids
  • Severe nausea, vomiting, gastrointestinal diseases, swallowing problems, or absorption issues
  • Live vaccine administration within 2 weeks before first medication
  • Pregnant or breastfeeding women
  • Allergy to study drugs or their components
  • 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

Yongchang Zhang

Changsha, Hunan, China, 410013

Actively Recruiting

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Research Team

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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