Clinical trial · Interventional
A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic 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
- 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 study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic 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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebelimab (SHR-1316) | Drug | — | UNRESOLVED |
| SHR-8068 | Drug | — | UNRESOLVED |
| SHR-A2102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A2102 in Combination with Adebrelimab and SHR-8068
- interventionNames
- Drug: SHR-A2102
- Drug: Adebelimab (SHR-1316)
- Drug: SHR-8068
Primary outcomes (3)
- measure
- Determination of Recommended Phase II dose (RP2D)
- timeFrame
- From first dose of study treatment until the end of Cycle 1（up to 21 days）
- measure
- Objective Response Rate (ORR)
- timeFrame
- From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
- description
- The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available