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

NCT04814056 | Unknown Phase 4

• 1 other identifier: BI-IIT-AFATINIB-I
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NRG1-fused Non-small Cell Lung Cancer

Keywords

Locally advanced (stage IIIB) or metastatic (stage IV); have previously received platinum-based doublet chemotherapy and developed disease progression subsequently

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR

  Up to 12 months

Secondary Outcomes (2)

• disease control rate (DCR)

  Up to 12 months

• progression-free survival (PFS)

  Up to 12 months

Study Arms (1)

Afatinib treatment group

EXPERIMENTAL

This is an open-label, sing-arm phase IV clinical study

Drug: Afatinib Dimaleate

Interventions

Afatinib Dimaleate DRUG

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.

Also known as: GIOTRIF®

Afatinib treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yongfeng Yu, Master

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongfeng Yu, Master

CONTACT

18017321559; yuyongfeng212@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 24, 2021
• Study Start: June 1, 2021
• Primary Completion: September 29, 2023
• Study Completion: January 31, 2024
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)