KCT0009147
Not yet recruiting
未知
A phase 2 trial to assess efficacy and safety of T-DXd in HER2-mutant advanced lung cancer patients with asymptomatic brain metastases.
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 27
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 20 or more than 20 years\-old
- •2\. Histologically confirmed, locally advanced and unresectable NSCLC not amenable to treatment with curative intent (surgery or chemoradiotherapy) or recurrent or de novo\-metastatic non\-squamous NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology) locally advanced or metastatic non\-squamous NSCLC (Participants with mixed histology are eligible if adenocarcinoma is the predominant histology).
- •3\. Activating HER2\-mutation documented by NGS in tissue or plasma (include activating HER2 mutation in exon 19 or 20, i.e. , Exon 20: A775\_G776insYVMA insertion/duplication; point mutations, L755S and G776C; transmembrane and the juxtamembrane domains G660D, R678Q, E693K and Q709Ldocumented mutation) regardless of HER2 expression.
- •HER2 expression on tissue based on IHC (IHC 1\+, 2\+, or 3\+)
- •4\. Asymptomatic brain metastases at baseline without local therapy for brain metastasis or stable brain metastasis after local therapy (WBRTx, SRS, GKS etc), which is defined as patients who are not requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- •5\. Prior failure on any systemic chemotherapy platinum\-based chemotherapy
- •6\. Measurable disease according to RECIST version 1\.1Response Assessment in Neuro\-Oncology Criteria (RANO)
- •7\. LVEF \= 50% within 28 days before randomization/enrollmentfirst dose .
- •8\. Eastern Cooperative Oncology Group performance status (ECOG PS) 0\-1\.
- •9\. Adequate organ and bone marrow function within 14 days before randomization/enrolmentfirst dose as described in Table 1 below. All parameters must meet the inclusion criteria on the same day, and must be the most recent results available.
Exclusion Criteria
- •1\. Active brain metastases that require intervention
- •2\. Leptomeningeal metastases
- •3\. Systemic antitumor therapy within 28 days(Targeted therapy, \= 2 weeks or 5 half\-lives) before initiation of T\-DXd
- •4\. Radiation therapy(excluding palliative stereotactic radiation therapy to chest) or gamma\-knife surgery within 2weeks before initiation of T\-DXd
- •5\. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results.
- •6\. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with untreated but clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment/randomization.
- •7\. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade \= 2 or baseline
- •8\. Patients with a medical history of myocardial infarction (MI) within 6 months before enrolment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV),
- •9\. History of (non\-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •10\. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.(Using for prophylactic antibiotics is allowed.)
Outcomes
Primary Outcomes
Not specified
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