RecruitingPhase 2NCT07175220

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

200 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria20

  • 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

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


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07175220


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