RecruitingPhase 2NCT04136535

Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC

A Multicenter, Randomized, Phase II Study of Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Advanced or Locally-advanced Osimertinib-resistant Non-squamous Non-small Cell Lung Cancer (ALTER-L031)


Sponsor

Fudan University

Enrollment

105 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the efficacy and safety of Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin versus Pemetrexed and Carboplatin for advanced or locally-advanced Osimertinib-resistant non-squamous non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called anlotinib to standard chemotherapy (pemetrexed and carboplatin) improves outcomes for people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation (EGFR) and has stopped responding to a drug called osimertinib. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic non-squamous NSCLC confirmed by tissue biopsy - Your cancer has the EGFR mutation and has progressed (worsened) on osimertinib - Your tumor can be measured on imaging - Your life expectancy is at least 3 months and overall health is good - Your blood counts and organ function (kidney, liver) are within acceptable levels **You may NOT be eligible if...** - You have small cell lung cancer or mixed adenosquamous lung cancer - You have active brain metastases (cancer that has spread to the brain and is not controlled) - Uncontrolled high blood pressure - You have serious heart disease or clotting/bleeding problems - You have had major surgery in the past 4 weeks or a major infection - You are pregnant or breastfeeding - You have had significant recent bleeding (coughing up blood) 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

DRUGPemetrexed

Pemetrexed,500mg/m²,ivgtt ,d1,q3w

DRUGCarboplatin

Carboplatin,AUC 5.0,ivgtt,d1,q3w,

DRUGAnlotinib

Anlotinib ,12 mg,po,qd,d1-14,q3w;


Locations(1)

Caner hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Uninon Medical college

Shenzhen, shenzhen, China

View Full Details on ClinicalTrials.gov

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NCT04136535


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