Clinical trial · Interventional
Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
NCT06434103CI-TRIAL-00107570withdrawnPhase 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
Why stopped (as posted): Sponsor's Strategy Adjustment
Summary
Brief summary (as posted)
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
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 |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1921;Adebrelimab;SHR-8068;carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
- interventionNames
- Drug: SHR-A1921;Adebrelimab;SHR-8068;carboplatin
Primary outcomes (2)
- measure
- DLT
- timeFrame
- 21 days after the first dose
- measure
- ORR based on RECIST v1.1 assessment.
- timeFrame
- All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Secondary outcomes (2)
- measure
- Adverse event
- timeFrame
- All informed subjects signed informed consent from the beginning to the end of the safety follow-up period, up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up; 2. Aged 18-75 at the time of signing the informed consent; 3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy; 4. At least one measurable lesion consistent with RECIST v1.1; 5. ECOG PS score: 0-1; 6. The organ function level is good; Exclusion Criteria: 1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.; 2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms; 3. Previous or co-existing malignant neoplasms; 4. The presence of any active or known autoimmune disease; 5. Have clinical symptoms or diseases of the heart that are not well controlled; 6. People with past or current interstitial pneumonia/interstitial lung disease; 7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies; 8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;
References
Publications (0)
Data not yet available
No reference posted for this study.