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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NRG1-fused Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Afatinib Dimaleate

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).

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital
      • Contact: Yongfeng Yu, Master; Phone Number: 18017321559

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure.
• Aged 18 years or older.
• Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens.
• The patient has received platinum-based doublet chemotherapy previously.
• ECOG performance status score is 0~2.
• The patient has sufficient bone marrow and organ functionality, which can be proved by complete blood cell count, blood biochemistry and urine biochemistry tests at baseline.
• The patient has measurable lesion(s).
• The female patient of childbearing age must adopt appropriate contraceptive measures and are not allowed to breastfeed a child.
• The male patient must voluntarily use contraceptives.

Exclusion Criteria:

• The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions.
• The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3.
• The patient has been found with symptomatic metastatic tumor of central nervous system (CNS).
• The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy.
• The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Afatinib treatment group; This is an open-label, sing-arm phase IV clinical study

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.; Other Names: GIOTRIF®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate (ORR)	ORR	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control rate (DCR)	DCR	Up to 12 months
progression-free survival (PFS)	PFS	Up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 29, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Locally advanced (stage IIIB) or metastatic (stage IV); have previously received platinum-based doublet chemotherapy and developed disease progression subsequently
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: BI-IIT-AFATINIB-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No