Small Cell Lung Carcinoma
Conditions
Brief summary
This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.
Interventions
DRUGpaclitaxel
80mg/m\^2,iv,Q4W
DRUGIBI318
300mg,iv,Q4W
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed the Informed Consent Form; 2. Male or female ≥ 18 and≤75 years of age; 3. Life expectancy ≥ 12 weeks; 4. Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging; 5. At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression.
Exclusion criteria
1. Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy; 2. Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug; 3. Received any investigational agent within 4 weeks prior to the first dose of study drug; 4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose; 5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 6. Pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 3 months | The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity. |
| Objective remission rate | 12 months | Proportion of subjects with complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to response (TTR) | 12 months | Time from randomization to first objective tumor response (CR or PR). |
| Continuous remission time (DOR) | 12 months | For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death. |
| Overall survival (OS) | 12 months | Defined as the time from randomization to death due to any cause. |
| Progression-free survival (PFS) | 12 months | Defined as the time from randomization to the first occurrence of objective disease progression or death. |
| Disease Control Rate (DCR) | 12 months | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). |
Countries
China
Outcome results
None listed