Locally Advanced or Metastatic Non-small Cell Lung Cancer
Conditions
Brief summary
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
Interventions
DRUGSHR2554; SHR-A2102
SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days
DRUGSHR2554; Adabelimumab
SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days
DRUGSHR2554; SHR-1701
SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age range of 18-75 years old (including both ends), gender not limited; 2. Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology 3. ECOG score is 0 or 1 4. Expected survival period ≥ 12 weeks 5. Has a good level of organ function 6. Patients voluntarily joined the study and signed informed consent
Exclusion criteria
1. Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc 2. Symptomatic or active central nervous system tumor metastasis 3. Previously or simultaneously suffering from other malignant tumors 4. Spinal cord compression that cannot be cured by surgery and/or radiotherapy 5. Accompanied by uncontrolled tumor related pain 6. Plan to receive any other anti-tumor treatment during this trial period 7. Receive other anti-tumor treatments within 4 weeks before the first medication 8. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration 9. Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study 10. Moderate to severe pleural effusion with clinical symptoms 11. Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication 12. Subjects who have experienced severe infections within 30 days prior to their first medication use 13. Administer attenuated live vaccine within 30 days before the first use of medication. 14. History of immunodeficiency 15. Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases 16. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past 17. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1 18. Untreated active hepatitis 19. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. 20. There are other serious physical or mental illnesses or laboratory abnormalities present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT | 21days after the first administration of each subject |
| AE | from Day1 to 30 days after last dose |
| Incidence and severity of serious adverse events (SAE) | from Day1 to 30 days after last dose |
| ORR | from first dose to disease progression or death, whichever comes first, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenic indicators: anti-SHR-A2102 antibody (ADA) | through study completion, an average of 2 years |
| overall survival (OS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Duration of response (DoR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| disease control rate (DCR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| progression free survival (PFS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
Countries
China
Contacts
Primary ContactXiaoxue Pi
Outcome results
None listed