Advanced Lung Cancer
Conditions
Brief summary
This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
Interventions
BIOLOGICALIBI939
IBI939 injection
BIOLOGICALSintilimab
Sintilimab injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1 5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements. 6. Histologically or cytologically confirmednon-small cell lung cancer
Exclusion criteria
1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine; 2. Received the last anti-tumor therapy 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 6 months | Proportion of subjects with complete response(CR) or partial response(PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) | 24 hours | — |
| Trough concentration (Cmin) | 24 hours | — |
| Clearance (CL), 12. volume of distribution (V) | 24 hours | — |
| adverse event | 3 months | — |
| Progression-free survival(PFS) | 6 months | The time from randomization to the first occurrence of objective disease progression or death |
| Area under the plasma concentration-time curve (AUC) | 24 hours | — |
| Disease Control Rate(DCR) | 6 months | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). |
| Duration of Response (DoR) | 6 months | The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death. |
| Time to Objective Response(TTR) | 6 months | Time from randomization to first objective tumor response (CR or PR). |
| Half-life (t1/2) | 24 hours | — |
| Overall Survival(OS) | 6 months | The time from randomization to death due to any cause. |
Countries
China
Outcome results
None listed