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New treatment option for Non-small Cell Lung Cancer
Official title SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT05351788
What this study is testing
What is SKB264?
SKB264 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;
- Histologically and cytologically confirmed NSCLC;
- Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic...
- Provide fresh or archival tumor tissue for biomarker testing and analysis;
- Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;
You likely can't join if
- Presence of small cell lung carcinoma (SCLC) components in histological pathology;
- History of other malignancies;
- Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;
- Presence of active central nervous system (CNS) metastases;
- Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade...
- Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment, including any of the following:
See the full eligibility criteria
- Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;
- Histologically and cytologically confirmed NSCLC;
- Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2...
- Provide fresh or archival tumor tissue for biomarker testing and analysis;
- Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks;
- Adequate organ and bone marrow function
- For female patients of childbearing age and male patients with partners of childbearing age, they must use effective medical contraception during the study treatment period and for 6 months after the last dose of study...
- Each patient must voluntarily agree to participate in the study, sign the informed consent form, and comply with the protocol-specified visits and relevant procedures.
- Presence of small cell lung carcinoma (SCLC) components in histological pathology;
- History of other malignancies;
- Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;
- Presence of active central nervous system (CNS) metastases;
- Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade important blood vessels during the subsequent study to cause fatal major...
- Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment, including any of the following:
- Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;
- Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or...
- Certain viral infections including active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); or positive syphilis antibody...
- Known active tuberculosis;
- Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Pregnant or lactating women;
- Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc
- Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.