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

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (NCT07175220) is a Phase 2 interventional studying Locally Advanced or Metastatic Non-small Cell Lung Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced or Metastatic Non-small Cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Locally Advanced or Metastatic Non-small Cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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 weakened immune system 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07175220), the sponsor (Jiangsu HengRui Medicine Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07175220 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07175220?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07175220?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07175220. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07175220. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.