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 range18 Years – 75 Years
SexALL
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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.
✓. 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.