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Recruiting NCT07175220

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

Phase II Interventional Locally Advanced or Metastatic Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR2554; SHR-A2102, SHR2554; Adabelimumab, SHR2554; SHR-1701.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • 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

Primary outcome measures

  • DLT [Time frame: 21days after the first administration of each subject]
  • AE [Time frame: from Day1 to 30 days after last dose]
  • Incidence and severity of serious adverse events (SAE) [Time frame: from Day1 to 30 days after last dose]
  • ORR [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
Secondary outcome measures (5)
  • Immunogenic indicators: anti-SHR-A2102 antibody (ADA) [Time frame: through study completion, an average of 2 years]
  • Duration of response (DoR) [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • disease control rate (DCR) [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • progression free survival (PFS) [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • overall survival (OS) [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07175220 · SHR2554-203-LC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗