Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05271916

First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

Led by Shanghai Chest Hospital · Updated on 2023-04-19

140

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.

CONDITIONS

Official Title

First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Signed informed consent
  • Histologically confirmed unresectable, inoperable, locally advanced, recurrent, or metastatic stage IIIB or IV NSCLC
  • Presence of EGFR activating mutation (exon 19 deletion and L858R in exon 21 for Phase I; L858R in exon 21 only for Phase IIb)
  • At least one measurable disease by RECIST 1.1 criteria
  • Patients with controlled or stable brain metastases
  • ECOG performance status 0-1 and life expectancy of at least 3 months
  • No prior systemic therapy for advanced NSCLC, including traditional Chinese medicine treatments
  • Able to follow study procedures and take oral medications
  • Adequate bone marrow, liver, kidney, and cardiac function as specified
Not Eligible

You will not qualify if you...

  • Small cell lung cancer or squamous cell carcinoma with cavitation
  • Concurrent EGFR T790M mutation, unknown mutation status, or other mutation types
  • Diagnosis of other malignancies within the past 5 years or current other malignancies
  • Pre-existing meningeal metastases
  • History of hemoptysis, hematochezia, or bloody sputum
  • Tumor invasion of or adjacent to major vessels
  • Uncontrolled or significant systemic diseases including active infection, thyroid dysfunction, uncontrolled hypertension, unstable angina, heart failure, recent myocardial infarction, or severe arrhythmia
  • Diseases or conditions that prevent use of investigational drug or affect study results
  • Gastrointestinal disorders preventing oral medication intake or requiring IV nutrition
  • Pregnant or lactating females
  • Allergy to any study drug ingredient

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

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

B

Bo 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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