Clinical trial · Interventional
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer
A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategy adjustments, independent of the safety and efficacy of the trial medication
Summary
Brief summary (as posted)
This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.
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 |
|---|---|---|---|
| Squamous-cell Non-Small-cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| SCT-I10 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- SCT-I10A plus Docetaxel
- description
- SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles
- interventionNames
- Drug: SCT-I10
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Placebo puls docetaxel
- description
- Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles
- interventionNames
- Drug: Docetaxel
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Maintenance therapy of SCT-I10A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients should be voluntarily sign the written informed consent. 2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition. 3. At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated could be considered as a target lesion only in the condition that progression occurred at the time of 3 months after the end of radiotherapy. 4. Previously treated with one platinum based regimen (including platinum and endostar regimen) and progression occur during or after treatment or unbearable treatment related adverse events. 5. Progression after EGFR-TKIs in patients with driver gene mutation. 6. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. Exclusion Criteria: 1. Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug. 2. Patient who is allergic to taxane. 3. Previously treated with any of the antibodies targeted on PD-1, PD-L1, PD-2, CD137, CTLA-4, T cell, co-stimulation or drugs targeted on the checkpoint signal pathway. 4. Previously treated with docetaxel. 5. The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell \< 90% in a mixed carcinoma.
References
Publications (1)
- DERIVEDHan B, Wu L, Yang R, Wu H, Li W, Yu Y, Zhang M, Sun H, Chu T, Zhong F, Fang Y, Wu R, Bian T, Guo X, Sun M, Zhang Y, Liu L, Liu X, Pan Y, Jiang O, Wei Z, Lin H, Guo W, Fang J, Wang J, Ding C, Hu Y, Ye F, Zhuang W, Ye S, Wang L, Huang Z, Liu C, Yang L, Wang J, Xie L. Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial. Transl Lung Cancer Res. 2025 Apr 30;14(4):1231-1241. doi: 10.21037/tlcr-24-1042. Epub 2025 Apr 16. PMID 40386729