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NCT Number: NCT07175220

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Li Zhang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR2554; SHR-A2102

Drug

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

SHR2554; Adabelimumab

Drug

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

SHR2554; SHR-1701

Drug

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

Primary outcomes

  1. DLT

    Time frame: 21days after the first administration of each subject

  2. AE

    Time frame: from Day1 to 30 days after last dose

  3. Incidence and severity of serious adverse events (SAE)

    Time frame: from Day1 to 30 days after last dose

  4. ORR

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary outcomes

  1. Immunogenic indicators: anti-SHR-A2102 antibody (ADA)

    Time frame: through study completion, an average of 2 years

  2. Duration of response (DoR)

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  3. disease control rate (DCR)

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  4. progression free survival (PFS)

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  5. overall survival (OS)

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoxue Pi

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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 dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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