NCT07003321 A Trial of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
| NCT ID | NCT07003321 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-09-12 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18 to 80 years old; Both men and women are welcome; 2. Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens. 3. ECOG ratings of 0 or 1. 4. Expected survival period ≥ 12 weeks. 5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition. 6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits. Exclusion Criteria: 1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis 2. There have been significant severe infections and major surgeries in the past 4 weeks 3. Existence of previous or concurrent malignant tumors 4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication 5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery within 7 days prior to the first administration of medication
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07003321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07003321 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07003321 currently recruiting?
Yes, NCT07003321 is actively recruiting participants. Contact the research team at liju.zong@hengrui.com for enrollment information.
Where is the NCT07003321 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07003321 clinical trial?
NCT07003321 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 120 participants.