Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations (NCT06519110) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
60 participantsStarted 2024-08-10
Plain-language summary
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.Age is 18 years or older, and the patient can be male or female;
* 2.Histologically or cytologically confirmed advanced non-small cell lung cancer, cholangiocarcinoma, cervical cancer, and salivary gland cancer patients; those who have failed to respond to ≤2 lines of standard treatment (disease progression after treatment or intolerable toxic side effects of treatment), or have no standard treatment options, or are unable to receive standard treatment;
* 3.Previously underwent second-generation sequencing testing with evidence of HER2 mutation, otherwise, the patient must provide sufficient tissue samples for second-generation sequencing testing in the study's central laboratory, with tissue samples being the primary source; if tissue slices or samples that meet the requirements cannot be obtained, blood samples may be provided for testing.
* 4.According to the RECIST v1.1 criteria (see Appendix 1), there must be at least one measurable lesion; if the only lesion is one that has previously received local treatment (such as radiotherapy, ablation, interventional treatment, etc.), there must be clear radiological evidence of disease progression;
* 5.Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
* 6.Predicted survival is 3 months or more;
* 7.Bone marrow reserve must meet the following laboratory value criteria: Absolute neutrophil count (ANC) is ≥1.5 × 10\^9/L; Platelet count (PLT) is ≥90 × 10\^9/L; Hemoglobin (Hb) is ≥90 g…
What they're measuring
1
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Timeframe: Throughout the study for approximately 3.5 years