SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer
Squamous-cell Non-Small-cell Lung Cancer
About this trial
This is an interventional treatment trial for Squamous-cell Non-Small-cell Lung Cancer focused on measuring Non-small cell lung cancer, Squamous cell carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients should be voluntarily sign the written informed consent.
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
- 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.
- 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.
- Progression after EGFR-TKIs in patients with driver gene mutation.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Exclusion Criteria:
- Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
- Patient who is allergic to taxane.
- 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.
- Previously treated with docetaxel.
- The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell < 90% in a mixed carcinoma.
Sites / Locations
- Shanghai Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Placebo Comparator
SCT-I10A plus Docetaxel
Placebo puls docetaxel
Maintenance therapy of SCT-I10A
Maintenance therapy of Placebo
SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles
Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: SCT-I10A 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: Placebo 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.