Clinical trial NCT05026593: A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Official title: A Randomized, Multicenter, Open-Label, Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of IBI110 in Combination With Sintilimab Plus Etoposide and Platinum or Carboplatin in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SCLC
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients must have the ability to understand and voluntarily sign informed consent;
2. Age: over 18 years old;
3. Expected survival period ≥ 3 months;
4. Histologically or cytologically confirmed ES-SCLC (according to the Veterans Lung Administration Lung Study Group, VALG staging);
5. No prior systemic treatment for ES-SCLC;
6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1;
7. At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Eval -uation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria;
8. Adequate hematologic and end organ function.

Exclusion Criteria:

1. Have been previously exposed to any antibody or drug of immune-mediated therapy, including but not limited to LAG-3, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1 antibodies.
2. Have received systemic treatment with Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first administration of study drug.
3. Have active or uncontrolled central nervous system (CNS) metastases and/or spinal cord compression and/or carcinomatous meningitis, or history of leptomeningeal carcinoma. Subjects with a history of radiotherapy or surgery for brain metastases and asymptomatic CNS metastases at the time of screeing are eligible if they meet all of the following criterias: have measurable lesions outside the CNS; do not have midbrain, pons, meninges, medulla oblongata or spinal cord metastases; do not have evidence of new or enlarged brain metastases after treatment for brain metastases, and corticosteroids and anticonvulsants treatments have been discontinued for at least 14 days prior to the study treatment. Subjects with asymptomatic brain metastases can be included if the brain metastases have been treated with radiotherapy and above mentioned criterias are all met.
4. Are expected to require any other antineoplastic therapy while in study (PCI is allowed).
5. Have received administration of live attenuated vaccines within 4 weeks prior to the first administration of study drug or anticipation that such a live attenuated vaccine will be required during the study.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
measure: 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
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: Up to 5 years
measure: Objective response rate(ORR)
timeFrame: Up to 5 years
measure: Disease control rate(DCR);
timeFrame: Up to 5 years
measure: Duration of response(DOR);
timeFrame: Up to 5 years
measure: To assess the immunogenicity;
timeFrame: Up to 5 years
measure: To assess the Area under the plasma concentration versus time curve(AUC) of IBI110+Sintilimab+EP
timeFrame: Up to 1 year
measure: To assess the Peak Plasma Concentration(Cmax) of IBI110+Sintilimab+EP
timeFrame: Up to 1 year
measure: To assess the half-life(t1/2) of IBI110+Sintilimab+EP
timeFrame: Up to 1 year
measure: To assess the clearance(CL) of IBI110+Sintilimab+EP
timeFrame: Up to 1 year
measure: To assess the volume of distribution(V) of IBI110+Sintilimab+EP
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References: