Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Non-small Cell Lung Cancer

Treatments: Drug: Adebrelimab；platinum-based chemotherapy; Drug: SHR-8068；Adebrelimab; Drug: SHR-8068；adebrelimab and platinum-based chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05416775

SHR-8068-II-201-NSCLC

Details and patient eligibility

About

To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

168 participants in 3 patient groups

SHR-8068 in combination with adebrelimab

Experimental group

Treatment:

Drug: SHR-8068；Adebrelimab

SHR-8068 in combination with adebrelimab and platinum-based chemotherapy

Experimental group

Treatment:

Drug: SHR-8068；adebrelimab and platinum-based chemotherapy

Adebrelimab in combination with platinum-based chemotherapy

Experimental group

Treatment:

Drug: Adebrelimab；platinum-based chemotherapy