SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
Provide a tumor tissue sample.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Disqualifiers
Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
Uncontrolled systemic disease as judged by the investigator.
Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
Trial design
Treatments tested in this trial
- SKB264+SKB118
Treatment groups
206 Participants
are divided into 1 treatment groupLocations
2Jilin Cancer Hospital Jilin City China
Shanghai East Hospital, Tongji University Shanghai China
Sponsors and collaborators
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov