Status:
UNKNOWN
To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
NRG1-fused Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (...
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/me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04814056
Start Date
June 1 2021
End Date
January 31 2024
Last Update
April 1 2021
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China