RecruitingPhase 1Phase 2NCT05271916

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

An Open Label, Multicenter, Phase I/IIB Study of Dacomitinib Plus Anlotinib for Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) 21-L858R Mutations.


Sponsor

Shanghai Chest Hospital

Enrollment

140 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining two targeted drugs — dacomitinib and anlotinib — as a first treatment for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation (EGFR L858R). **You may be eligible if...** - You are 18–75 years old - You have advanced or metastatic NSCLC with the EGFR L858R mutation in exon 21 - You have not yet received any systemic treatment for advanced NSCLC - You have measurable disease by imaging - Your performance status is good (ECOG 0–1) - Brain metastases are allowed if stable or controlled **You may NOT be eligible if...** - You have received prior chemotherapy or targeted therapy for advanced NSCLC - You have a different EGFR mutation (not L858R) - Your brain metastases are uncontrolled - Your organ function (liver, kidneys, blood) is inadequate - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDacomitinib+Anlotinib

The dose of each drug in the combination Decomitinib and Anlotinib will be escalated or de-escalated until the recommended phase II dose (RP2D) is reached. Patients will then be treated with RP2D orally once a day.

DRUGDacomitinib

Dacomitinib orally on a continuous daily basis at a starting dose of 45 mg once a day until progressive disease.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT05271916


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