Clinical trial · Interventional
A Trial of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Study on Efficacy and Safety of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-4508 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Part A/B/C
- description
- PartA:HRS-4508 tablet+SHR-A1811 PartB:HRS-4508 tablet+ Adebrelimab Injection PartC:HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection
- interventionNames
- Drug: HRS-4508 tablet
Primary outcomes (5)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 2 month
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 2 month
- measure
- Determine dose recommendation (RP2D)
- timeFrame
- 6month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 to 75 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
References
Publications (0)
Data not yet available