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

NCT07175220 | Recruiting Phase 2

• 1 other identifier: SHR2554-203-LC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Locally Advanced or Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• DLT

  21days after the first administration of each subject

• AE

  from Day1 to 30 days after last dose

• Incidence and severity of serious adverse events (SAE)

  from Day1 to 30 days after last dose

• ORR

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

Secondary Outcomes (5)

• Immunogenic indicators: anti-SHR-A2102 antibody (ADA)

  through study completion, an average of 2 years

• Duration of response (DoR)

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

• disease control rate (DCR)

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

• progression free survival (PFS)

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

• overall survival (OS)

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

Study Arms (3)

Queue A

EXPERIMENTAL

Drug: SHR2554; SHR-A2102

Queue B

EXPERIMENTAL

Drug: SHR2554; Adabelimumab

Queue C

EXPERIMENTAL

Drug: SHR2554; SHR-1701

Interventions

SHR2554; SHR-A2102 DRUG

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

Queue A

SHR2554; Adabelimumab DRUG

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

Queue B

SHR2554; SHR-1701 DRUG

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

Queue C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiaoxue Pi

CONTACT

0518-82342973; Xiaoxue.pi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

CN (1)