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

NCT ID: NCT07175220

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Queue A

Group Type EXPERIMENTAL

SHR2554; SHR-A2102

Intervention Type DRUG

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

Queue B

Group Type EXPERIMENTAL

SHR2554; Adabelimumab

Intervention Type DRUG

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

Queue C

Group Type EXPERIMENTAL

SHR2554; SHR-1701

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR2554; SHR-A2102

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

Intervention Type DRUG

SHR2554; Adabelimumab

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

Intervention Type DRUG

SHR2554; SHR-1701

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age range of 18-75 years old (including both ends), gender not limited;
2. Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
3. ECOG score is 0 or 1
4. Expected survival period ≥ 12 weeks
5. Has a good level of organ function
6. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria

1. 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
2. Symptomatic or active central nervous system tumor metastasis
3. Previously or simultaneously suffering from other malignant tumors
4. Spinal cord compression that cannot be cured by surgery and/or radiotherapy
5. Accompanied by uncontrolled tumor related pain
6. Plan to receive any other anti-tumor treatment during this trial period
7. Receive other anti-tumor treatments within 4 weeks before the first medication
8. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
9. 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
10. Moderate to severe pleural effusion with clinical symptoms
11. Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
12. Subjects who have experienced severe infections within 30 days prior to their first medication use
13. Administer attenuated live vaccine within 30 days before the first use of medication.
14. History of immunodeficiency
15. Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
16. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
17. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
18. Untreated active hepatitis
19. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
20. There are other serious physical or mental illnesses or laboratory abnormalities present
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaoxue Pi

Role: CONTACT

0518-82342973

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHR2554-203-LC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase I Study of SPH1188-11 in NSCLC
NCT03231475 WITHDRAWN PHASE1