SHR2554 combined with other cancer drugs for advanced non-small cell lung cancer

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

This study tests whether SHR2554 tablets given with other anti-cancer treatments are safe and can shrink tumors in adults with locally advanced or metastatic non-small cell lung cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07175220 on ClinicalTrials.gov

What this trial studies

This phase II, open-label interventional study enrolls adults (18–75 years) with pathologically confirmed locally advanced unresectable or metastatic NSCLC and ECOG 0–1. Participants receive oral SHR2554 combined with one of several partner anti-tumor agents (for example SHR-A2102, adabelimumab, or SHR-1701) and are monitored for safety, tolerability, and objective tumor response by imaging at scheduled visits. Key exclusions include symptomatic or active central nervous system metastases, other active malignancies, inability to swallow or malabsorption issues, recent anti-cancer therapy within 4 weeks, uncontrolled tumor-related pain, or spinal cord compression not amenable to treatment. Primary endpoints include safety, tolerability, and objective response rate with routine lab tests and radiographic assessments to track responses and adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with pathologically confirmed locally advanced unresectable or metastatic NSCLC, ECOG 0–1, adequate organ function, expected survival of at least 12 weeks, and ability to take oral medication who consent to participate.

Not a fit: Patients with poor performance status (ECOG ≥2), symptomatic or active brain metastases, other concurrent malignant tumors, recent anti-cancer therapy, or inability to swallow oral drugs are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, these combinations could increase tumor response rates and provide new treatment options for people with advanced NSCLC.

How similar studies have performed: Combining epigenetic or targeted agents with immunotherapies or other systemic therapies has shown early signals of activity in NSCLC, but SHR2554-specific clinical data are currently limited.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xiaoxue Pi

Conditions: Locally Advanced or Metastatic Non-small Cell Lung Cancer