Treatment of advanced non-small cell lung cancer with SHR-8068 and adebrelimab

An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

This study is testing a new combination of two drugs, SHR-8068 and adebrelimab, to see if they can help people with advanced non-small cell lung cancer who haven't had success with standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, adebrelimab
• Locations: 18 sites (Hefei, Anhui and 17 other locations)
• Trial ID: NCT05416775 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of SHR-8068 in combination with adebrelimab for patients with advanced non-small cell lung cancer (NSCLC). It also assesses the efficacy of this combination alongside platinum-based chemotherapy. Participants will be monitored for their response to treatment and any adverse effects. The study aims to provide a new therapeutic option for patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced NSCLC who have failed standard treatments and have specific tumor characteristics.

Not a fit: Patients with certain genetic mutations or untreated brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with advanced NSCLC who have limited alternatives.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting advanced NSCLC with combination therapies.

Eligibility criteria

Inclusion Criteria:

1. Age 18\~75 years old, both male and female
2. Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
3. Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS \<50% as confirmed by central laboratory
4. At least one measurable lesion based on RECIST v1.1 criteria
5. ECOG PS score: 0-1 points
6. Expected survival period ≥ 3 months
7. Good levels of organ function
8. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
2. Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
3. Uncontrolled pleural, pericardial, or ascites with clinical symptoms
4. Severe bone damage caused by tumor bone metastasis
5. Suffering from other malignant tumors in the past 3 years or at the same time
6. Presence of any active or known autoimmune disease
7. Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
8. Have clinical symptoms or diseases of the heart that are not well controlled
9. Serious infection occurred within 1 month before the first dose
10. Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function
11. With active pulmonary tuberculosis
12. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
13. Known history of inflammatory bowel disease
14. Inoculated with live attenuated vaccine within 28 days before the first dose
15. Known allergic reaction to other monoclonal antibodies
16. Received \>30 Gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose Received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE ≤1 degree
17. According to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.

Where this trial is running

Hefei, Anhui and 17 other locations

• Anhui Chest Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Anhui Provincial Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• West China Hospital Of Sichuan University — Chengdu, Chengdu, China (Not_yet_recruiting)
• Cancer Hospital Affiliated to Chongqing University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital of Jiangnan University — Wuxi, Jiangsu, China (Not_yet_recruiting)
• North Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• Affiliated Tumor Hospital of Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• Yunnan Cancer Hospital — Kunming, Yunan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Xin Xu

Conditions Advanced Non-small Cell Lung Cancer