Clinical trial NCT06335355: A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients
Official title: A Phase II/III, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11/KEAP1/KRAS Mutations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Non-squamous Non-small Cell Lung Cancer
Lead sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.
4. At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .
5. The participant is expected to have a life expectancy of at least 12 weeks.
6. Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.
7. The participant must have adequate bone marrow and organ function.

Exclusion Criteria:

1. Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.
2. Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.
3. Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
4. Subjects with inadequately controlled pain related to their tumor(s).
5. 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.
6. Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.
7. 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.
8. 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.
9. Subjects who have received systemic immunostimulant treatment within 4 weeks prior to starting the study treatment.
10. Subjects who have received systemic immunosuppressive treatment within 2 weeks prior to starting the study treatment.
11. Subjects with any active, known, or suspected autoimmune disease.
12. Subjects with severe heart disease.
13. Subjects who have experienced arterial or venous thrombotic events within 3 months prior to starting the study treatment.
14. Subjects with active syphilis infection.
15. Subjects who have had a severe infection within 4 weeks prior to starting the study treatment.
16. Subjects who have previously undergone or are planning to undergo allogeneic hematopoietic stem cell transplantation or organ transplantation.
17. Subjects with a history of severe hypersensitivity reactions to other monoclonal antibodies.
18. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
19. Subjects with a history of substance abuse of psychoactive drugs, alcoholism, or drug addiction.
20. Subjects whom the investigator believes have any medical condition (such as pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric conditions, or social circumstances that could potentially interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate, and participate in the study, or interfere with the assessment of the investigational drug, interpretation of subject safety data, or study results.

Primary outcomes:
measure: Investigator-assessed Objective Response Rate (Phase One)
timeFrame: about 3 years
measure: Overall Survival (Phase Two)
timeFrame: about 3.5 years
Secondary outcomes:
measure: The incidence and severity of Adverse Events (AEs) (Phases One and Two)
timeFrame: about 4.5 years
measure: Duration of Response (DoR) based on Investigator Assessment (Phases One and Two)
timeFrame: about 6.5 years
measure: Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two)
timeFrame: about 6.5 years
measure: Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two)
timeFrame: about 6.5 years
measure: Overall Survival (OS) (Phase One)
timeFrame: about 3.5 years
measure: Objective Response Rate (ORR) based on Investigator Assessment (Phase Two)
timeFrame: about 4.5 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Affiliated Tumor Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: