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NCT07175220RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
9 Sept 2025
Start date
9 Oct 2025
Primary completion date
Oct 2028
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Diseases
Lung cancer
NCT number
NCT07175220

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 9 Oct 2025 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously or simultaneously suffering from other malignant tumors
  • Spinal cord compression that cannot be cured by surgery and/or radiotherapy
  • 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
  • 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.
  • AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1

Other illness

  • 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
  • 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
  • Untreated active hepatitis

Lab values

  • There are other serious physical or mental illnesses or laboratory abnormalities present

Other

  • Symptomatic or active central nervous system tumor metastasis
  • Accompanied by uncontrolled tumor related pain
  • Plan to receive any other anti-tumor treatment during this trial period
  • Moderate to severe pleural effusion with clinical symptoms
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.