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NCT06868732PHASE1RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
Advanced Non-small Cell Lung Cancer
Interventions
JSKN016, Carboplatin, Furmonertinib Mesylate, Ivonescimab
Enrollment
288 participants
Primary completion
Jun 2028
Study completion
Dec 2028
First posted
Mar 2025
Last updated
Mar 2026

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov