NCT04136535

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin use 4 cycles,then continue pem and anlotinib until PD Pemetrexed and Carboplatin use 4 cycles,then continue pem until PD TO see the different of PFS and OS and safety between the two group

Conditions

• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed，500mg/m²，ivgtt ，d1，q3w
DRUG	Carboplatin	Carboplatin，AUC 5.0，ivgtt，d1，q3w，
DRUG	Anlotinib	Anlotinib ，12 mg，po，qd，d1-14，q3w；

Timeline

• Start date: 2021-11-18
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-10-23
• Last updated: 2025-07-22

Locations

1 site across 1 country: China