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

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Chest Hospital
• Treatments: Afatinib

Criteria

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.