A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or … (NCT06335355) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients
China401 participantsStarted 2024-03
Plain-language summary
Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.
. At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.
. Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.
. At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .
. The participant is expected to have a life expectancy of at least 12 weeks.
. Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines adebrelimab, SHR-8068, and chemotherapy — can you explain what each of these drugs does and why adding SHR-8068 to an immunotherapy-plus-chemo regimen might matter for non-squamous non-small cell lung cancer specifically?
2Since this is a Phase II/Phase III trial that hasn't started recruiting yet, what does that mean for how much safety and effectiveness data will exist by the time I might be able to enroll, and how does that compare to what's already known about standard treatments for my diagnosis?
3The trial is measuring response rate in Phase II and overall survival in Phase III — given where I am in my treatment journey, would it make more sense to wait for more mature survival data from this study, or is there a reason to consider it earlier?
4Because the trial isn't recruiting yet, is it worth putting my name on a list to be notified when it opens, and how long do you think it might realistically be before it starts enrolling patients?
5Are there currently approved standard-of-care options for my type of non-squamous non-small cell lung cancer that I should try first, and if so, how would participating in this trial fit alongside or after those treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The participant must have adequate bone marrow and organ function.
Exclusion criteria
. Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.
. Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.
. Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
. Subjects with inadequately controlled pain related to their tumor(s).
. Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.
. Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.
. Subjects whose toxicities and/or complications from previous interventions have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) Grade ≤1.
. Subjects participating in another clinical study or whose initiation of study treatment is less than 4 weeks since the end of the last clinical study (last dose administration), or less than five half-lives of that study drug, whichever is shorter.