Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC
Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
ORR assessed by the investigator per RECIST v1.1
Time frame: Up to 24months
Safety reflected by AE
Time frame: Up to 24months
Secondary Endpoints
DOR assessed by the investigator per RECIST v1.1
DCR assessed by the investigator per RECIST v1.1
TTR assessed by the investigator per RECIST v1.1
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form. 2. Age ≥ 18 years old, ≤ 75 years old, male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy. 6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria. 7. Recently archived or fresh tumor tissue samples are available. 8. Have good organ function. 9. Have no current birth plans and agree to contraception during the trial. Exclusion Criteria: 1. Presence of any small cell carcinoma component in histopathology. 2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-p…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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