A Trial of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-4508 tablet.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug HRS-4508 tablet
PartA ：HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB：HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC：HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose
Primary outcome measures
- Dose limiting toxicity (DLT) [Time frame: 2 month]
- Maximum tolerated dose (MTD) [Time frame: 2 month]
- Determine dose recommendation (RP2D) [Time frame: 6month]
- The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Time frame: 1 years]
- Objective response rate (ORR) [Time frame: 1 year]
Secondary outcome measures (5)
- Blood concentrations of HRS-4508 and SHR-A1811 [Time frame: 12 weeks]
- Duration of response (DoR) [Time frame: 1 year]
- Disease control rate (DCR) [Time frame: 1 year]
- Progression free survival (PFS) [Time frame: 1 year]
- Overall survival (OS) [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- Age: 18 to 75 years old; Both men and women are welcome;
- Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens.
- ECOG ratings of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
- Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.
Exclusion criteria
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- There have been significant severe infections and major surgeries in the past 4 weeks
- Existence of previous or concurrent malignant tumors
- Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Shanghai Chest Hospital — Shanghai
- Zhejiang Tumor Hospital — Hangzhou
Identifiers
NCT: NCT07232849 · HRS-4508-202-LC