To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Ce… (NCT04814056) | Clinical Trial Compass
UnknownPhase 4
To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion
China15 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 o…