Strategy adjustments, independent of the safety and efficacy of the trial medication

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.

In 2015, there were near 787,000 patients diagnosed with lung cancer in China. And in the very same year, 631,000 lung cancer patients died of the disease. Lung cancer still causes most cancer related death in here. Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC) compared with small cell lung cancer (~15%) pathologically. NSCLC include squamous cell NSCLC, adenocarcinoma and large cell carcinoma. Although there are therapies developed to treat the condition, patients with advanced squamous-cell (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options in China. Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. As designed in the protocol, 360 eligible subjects would be randomized into two arms in a ratio of 2:1. 240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. Both of these arms will be treated with maintenance therapy after planed treatments. Our primary endpoint is overall survival, secondary endpoints are PFS, OSR, ORR, DOR, DCR and other efficacy and safety index.

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.