Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

About this trial

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Eligibility criteria

Qualifiers

Voluntarily participate and sign the informed consent form.

Age ≥ 18 years old, ≤ 75 years old, male or female.

Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Expected survival ≥ 3 months.

Disqualifiers

Presence of any small cell carcinoma component in histopathology.

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-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ.

Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.

During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.

Trial design

Treatments tested in this trial

  • JSKN016
  • Carboplatin
  • Furmonertinib Mesylate
  • Ivonescimab
  • Docetaxel
  • Tislelizumab
  • Pembrolizumab

Treatment groups

288 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.