Clinical trial · Interventional
SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)
A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.
- 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 a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced 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 |
|---|---|---|---|
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SMET12 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma
- description
- toripalimab:3mg/kg, Q2W; SMET12:60μg,Q2W; Pemetrexed Disodium 500mg/m2 d+Carboplatin AUV=5 d1 Q3W,administered for 2\~4 cycles
- interventionNames
- Drug: SMET12
- type
- EXPERIMENTAL
- label
- Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma
- description
- toripalimab:3mg/kg, Q2W; SMET12:60μg,Q2W; paclitaxel 100mg/m2 d1,d8,d15+cisplatin 75mg/m2 d1 Q3W, administered for 2\~4 cycles
- interventionNames
- Drug: SMET12
- type
- EXPERIMENTAL
- label
- Subjects resistant to first-line treatment contain immune checkpoint inhibitors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures. 2\. Age ≥ 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry ≥ \[+\]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period \> 3 months). 4\. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival ≥ 3 months. 7. Adequate organ function . Exclusion Criteria: * 1\. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy. 4\. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator. 6\. Fertile individuals unable to maintain effective contraception during the trial. 7\. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors. 9\. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .
References
Publications (1)
- DERIVEDLin J, Chen S, Li M, Weng L, Xu H, Wang Q, Zhang J, Lin D, Wang H, Liu Q, He Z. Efficacy and safety of SMET12 in combination with toripalimab and chemotherapy in advanced non-small-cell lung cancer patients tested positive for EGFR protein who are treatment-naive or harbor acquired resistance to standard therapy: a phase 2, multi-cohort clinical trial. Front Immunol. 2026 Jan 8;16:1706961. doi: 10.3389/fimmu.2025.1706961. eCollection 2025. PMID 41583476