NCT04814056

To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion

An Open-Labeled, Single-Arm Clinical Study to Evaluate the Efficacy of Afatinib in Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With NRG1-Fusion

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.

Detailed description

This is an open-label, sing-arm clinical study,which will recruit about 15 patients in China. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment. Target Patient Population:Locally advanced (stage IIIB) or metastatic (stage IV) NRG1-fused non-small cell lung cancer patients, who have previously received platinum-based doublet chemotherapy and developed disease progression subsequently. Test Drug, Dosage and Medication Regimen:Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D. Evaluations of Study:The data to be collected include demographic characteristics of the patients, information necessary to determine whether the patients are qualified (including medical history, features of previous and current diseases and NRG1 fusion status in tumor tissue), and efficacy and safety data in terms of objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

Conditions

• NRG1-fused Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Afatinib Dimaleate	Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-09-29
• Completion: 2024-01-31
• First posted: 2021-03-24
• Last updated: 2021-04-01

Locations

1 site across 1 country: China