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RECRUITINGPhase 2INTERVENTIONAL

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects

A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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 weakened immune system 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

SHR2554; SHR-A2102

SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days

DRUG

SHR2554; Adabelimumab

SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days

DRUG

SHR2554; SHR-1701

SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days

Locations (1)

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China