Clinical trial · Interventional
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
NCT04814056CI-TRIAL-00050986unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NRG1-fused Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib Dimaleate | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Afatinib treatment group
- description
- This is an open-label, sing-arm phase IV clinical study
- interventionNames
- Drug: Afatinib Dimaleate
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- Up to 12 months
- description
- ORR
Secondary outcomes (2)
- measure
- disease control rate (DCR)
- timeFrame
- Up to 12 months
- description
- DCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.