Last updated: March 21, 2024
Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd
Overall Status: Active - Not Recruiting
Phase
2/3
Condition
N/ATreatment
Adebrelimab + Pemetrexed + Carboplatin
Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin
Camrelizumab + Pemetrexed + Carboplatin
Clinical Study ID
NCT06335355
SHR-1316-307
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The participant voluntarily joins this clinical research study, understands theresearch procedures, and is capable of providing written informed consent by signingthe Informed Consent Form.
- At the time of signing the Informed Consent Form, participants must be between theages 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 theRECIST 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 arealso allowed.
- The participant must have adequate bone marrow and organ function.
Exclusion
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 witha history of leptomeningeal metastasis, or those currently presenting withleptomeningeal metastasis.
- Subjects with spinal cord compression that has not been radically treated by surgeryand/or radiotherapy.
- Subjects with inadequately controlled pain related to their tumor(s).
- Subjects with a history of or concurrent other malignancies, except for basal cellcarcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma,in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ followingmastectomy (allowing for hormonal treatment for non-metastatic prostate or breastcancer), and papillary thyroid cancer which have achieved complete remission for atleast 5 years prior to screening and do not require or are not expected to requirefurther treatment during the study period.
- Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior toinitiating the study treatment.
- Subjects whose toxicities and/or complications from previous interventions have notresolved 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 studytreatment is less than 4 weeks since the end of the last clinical study (last doseadministration), or less than five half-lives of that study drug, whichever isshorter.
- Subjects who have received systemic immunostimulant treatment within 4 weeks prior tostarting the study treatment.
- Subjects who have received systemic immunosuppressive treatment within 2 weeks priorto starting the study treatment.
- Subjects with any active, known, or suspected autoimmune disease.
- Subjects with severe heart disease.
- Subjects who have experienced arterial or venous thrombotic events within 3 monthsprior to starting the study treatment.
- Subjects with active syphilis infection.
- Subjects who have had a severe infection within 4 weeks prior to starting the studytreatment.
- Subjects who have previously undergone or are planning to undergo allogeneichematopoietic stem cell transplantation or organ transplantation.
- Subjects with a history of severe hypersensitivity reactions to other monoclonalantibodies.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant duringthe study period.
- Subjects with a history of substance abuse of psychoactive drugs, alcoholism, or drugaddiction.
- 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 withthe subject's rights, safety, health, or ability to provide informed consent,cooperate, and participate in the study, or interfere with the assessment of theinvestigational drug, interpretation of subject safety data, or study results.
Study Design
Total Participants: 401
Treatment Group(s): 3
Primary Treatment: Adebrelimab + Pemetrexed + Carboplatin
Phase: 2/3
Study Start date:
March 01, 2024
Estimated Completion Date:
October 31, 2030
Connect with a study center
Affiliated Tumor Hospital of Shandong First Medical University
Jinan, Shandong 250117
ChinaSite Not Available
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