Evaluating a new treatment for advanced non-small cell lung cancer
Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study
This study is testing a new treatment for advanced non-small cell lung cancer to see if it is safe and effective for patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | adebelimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06589778 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and efficacy of SHR-A2102 in combination with adebelimab and SHR-8068 in patients suffering from locally advanced or metastatic non-small cell lung cancer. It consists of two phases: the first phase focuses on determining the safety and tolerability of the treatment, while the second phase aims to evaluate its effectiveness. The study is multicenter and open-label, allowing for a diverse patient population to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with unresectable locally advanced or metastatic non-small cell lung cancer.
Not a fit: Patients with active brain metastases or those who have received anti-tumor therapy within the last four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.
How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and targeted treatments in lung cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. Age 18\~70 years old. 3. Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer. 4. At least one measurable lesion per RECIST v1.1 criteria. 5. ECOG PS score: 0-1. Exclusion Criteria: 1. Active or symptomatic brain metastases. 2. Previous diagnosis of any other malignancy. 3. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion. 4. Received anti-tumor therapy 4 weeks prior to initiation of study treatment. 5. Uncontrolled tumor-related pain. 6. Subjects with severe cardiovascular and cerebrovascular diseases.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xin Xu
- Email: xin.xu@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.