Clinical trial · Interventional
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer
NCT06754930CI-TRIAL-00088644recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ametinib mesylate | Drug | — | UNRESOLVED |
| BP-102 | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| SHR-1316 | Drug | Adebrelimab | ALIAS |
| SHR-1826 | Drug | — | UNRESOLVED |
| SHR-8068 | Drug | — | UNRESOLVED |
| SHR-9839 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- interventionNames
- Drug: SHR-1826
- Drug: SHR-1316
- Drug: SHR-9839
- Drug: SHR-8068
- Drug: Ametinib mesylate
- Drug: BP-102
- Drug: Carboplatin
Primary outcomes (3)
- measure
- Recommended phase II dose (RP2D)
- timeFrame
- Screening up to study completion, an average of 1 year.
- measure
- Adverse events (AEs)
- timeFrame
- Screening up to study completion, an average of 1 year.
- measure
- Objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed NSCLC. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate organ function. 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Previous or co-existing malignancies. 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. Uncontrollable tumor-related pain. 5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing. 6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy. 8. With poorly controlled or severe cardiovascular disease. 9. Active hepatitis B and hepatitis C. 10. Patients with a history of immunodeficiency. 11. Severe infection 30 days before the first dose.
References
Publications (0)
Data not yet available
No reference posted for this study.