IBI110 is an investigational drug under evaluation for treatment of small cell lung cancer. The purpose of the study was to assess the Efficacy and Safety of IBI110 in combination with Sintilimab and chemotherapy with untreated ES-SCLC.
This Phase II, multicenter, open-lable study is designed to evaluate the safety and efficacy of IBI110 (anti-lymphocyte activation gene 3 \[LAG-3\] monoclonal antibody) and sintilimab (anti-programmed death 1 \[PD-1\] antibody) in combination with intravenous (IV) cisplatin/carboplatin plus (+) etoposide (EP) in treatment naïve patients with extensive-stage small cell lung cancer (ES-SCLC) . Sixty eligible subjects will be enrolled and randomized in a 1:1 ratio to the experimental arm or the control arm. The experimental arm will be IBI110+ sintilimab + EP Q3W for 4 cycles, followed by IBI110+ sintilimab Q3W until disease progression. The control arm will be sintilimab + EP Q3W for 4 cycles, followed by sintilimab Q3W until disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Carboplatin will be administered after completion of Sintilimab by IV infusion to achieve an initial target AUC of 5 mg/mL/min on Day 1.
Cisplatin 75 mg/m\^2 will be administered after completion of Sintilimab by IV infusion on Day 1.
Etoposide 100 mg/m\^2 will be administered by IV infusion following carboplatin or cisplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Progression-Free Survival (PFS)
PFS is defined as the time interval from ra ndomization to the date of the first docu mented tumor progression, based on inve stigator assessments (per RECIST 1.1), or death due to any cause, whichever come s first.
Time frame: Up to 5 years
Incidence of Treatment-related Adverse Events(TRAE), Serious Adverse Events (SAEs) and Immune-related adverse events (irAE) nation with sintilimab and EP in untreated ES-SCLC
Evaluate the safety and tolerability profile of IBI110 + sintilimab and EP in untreated ES-SCLC . Adverse events per CTCAE v5.0 criteria guidelines will be used to assess this outcome.
Time frame: Up to 5 years
Overall Survival(OS)
OS: Defined as the time interval from ran domization to death.
Time frame: Up to 5 years
Objective response rate(ORR)
ORR: Defined as the number of cases achi eving CR, or PR, as a percentage of patien ts with evaluable efficacy.
Time frame: Up to 5 years
Disease control rate(DCR);
DCR: The percentage of cases that achiev ed remission (PR+CR) and stable disease (SD) after treatment accounted for the n umber of evaluable cases.
Time frame: Up to 5 years
Duration of response(DOR);
DOR: Defined as the time from the first d ocumented objective response to the first documented progressive disease or deat h of any cause, whichever occurs first.
Time frame: Up to 5 years
To assess the immunogenicity;
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Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .
IBI110 RP2D will be administered by IV infusion on Day 1 of each 21-day .
Immunogenicity: the immunogenicity: will be evaluated by determining the inciden ce of anti-drug antibodies (ADA) and furt her testing ADA-positive serum specimen s for neutralizing antibody (Nab);
Time frame: Up to 5 years
To assess the Area under the plasma concentration versus time curve(AUC) of IBI110+Sintilimab+EP
Time frame: Up to 1 year
To assess the Peak Plasma Concentration(Cmax) of IBI110+Sintilimab+EP
Time frame: Up to 1 year
To assess the half-life(t1/2) of IBI110+Sintilimab+EP
Time frame: Up to 1 year
To assess the clearance(CL) of IBI110+Sintilimab+EP
Time frame: Up to 1 year
To assess the volume of distribution(V) of IBI110+Sintilimab+EP
Time frame: Up to 1 year