Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
Recruiting · NCT07175220 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SHR2554; AdabelimumabSHR2554; SHR-1701SHR2554; SHR-A2102
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age range of 18-75 years old (including both ends), gender not limited;
- Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
- ECOG score is 0 or 1
- Expected survival period ≥ 12 weeks
- Has a good level of organ function
- Patients voluntarily joined the study and signed informed consent
Exclusion criteria
- 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
- Symptomatic or active central nervous system tumor metastasis
- Previously or simultaneously suffering from other malignant tumors
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy
- Accompanied by uncontrolled tumor related pain
- Plan to receive any other anti-tumor treatment during this trial period
- Receive other anti-tumor treatments within 4 weeks before the first medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
- 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
- Moderate to severe pleural effusion with clinical symptoms
- Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
- Subjects who have experienced severe infections within 30 days prior to their first medication use
- Administer attenuated live vaccine within 30 days before the first use of medication.
- History of immunodeficiency
- Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
- History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
- AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
- Untreated active hepatitis
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- There are other serious physical or mental illnesses or laboratory abnormalities present
Where it is running
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China