- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026593
A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
July 17, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, NO.507,Zhengmin Road,Yangpu
- Shanghai Pulmonary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must have the ability to understand and voluntarily sign informed consent;
- Age: over 18 years old;
- Expected survival period ≥ 3 months;
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Lung Administration Lung Study Group, VALG staging);
- No prior systemic treatment for ES-SCLC;
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1;
- 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;
- Adequate hematologic and end organ function.
Exclusion Criteria:
- 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.
- 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.
- 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.
- Are expected to require any other antineoplastic therapy while in study (PCI is allowed).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sintilimab+EP
During each 21-day cycle, participants receive Sintilimab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
After the induction phase, participants will begin maintenance therapy with Sintilimab 200 mg intravenously (IV) Day 1 every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or other protocol-allowed reasons, whichever occurs first.
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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.
Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .
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Experimental: IBI110+Sintilimab+EP
During each 21-day cycle, participants receive IBI110 PR2D intravenously (IV) Day 1 PLUS Sintilimab 200 mg intravenously (IV) Day 1 PLUS etoposide 100 mg/m^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum (carboplatin titrated to an area under the plasma drug concentration-time curve [AUC] 5 IV on Day 1 OR cisplatin 75 mg/m^2 IV on Day 1).
After the induction phase, participants will begin maintenance therapy with IBI110 PR2D intravenously (IV) Day 1 PLUS Sintilimab 200 mg intravenously (IV) Day 1 every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or other protocol-allowed reasons, whichever occurs first.
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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.
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 .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS)
Time Frame: Up to 5 years
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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.
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Up to 5 years
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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
Time Frame: Up to 5 years
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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.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival(OS)
Time Frame: Up to 5 years
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OS: Defined as the time interval from ran domization to death.
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Up to 5 years
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Objective response rate(ORR)
Time Frame: Up to 5 years
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ORR: Defined as the number of cases achi eving CR, or PR, as a percentage of patien ts with evaluable efficacy.
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Up to 5 years
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Disease control rate(DCR);
Time Frame: Up to 5 years
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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.
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Up to 5 years
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Duration of response(DOR);
Time Frame: Up to 5 years
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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.
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Up to 5 years
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To assess the immunogenicity;
Time Frame: Up to 5 years
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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);
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Up to 5 years
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To assess the Area under the plasma concentration versus time curve(AUC) of IBI110+Sintilimab+EP
Time Frame: Up to 1 year
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Up to 1 year
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To assess the Peak Plasma Concentration(Cmax) of IBI110+Sintilimab+EP
Time Frame: Up to 1 year
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Up to 1 year
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To assess the half-life(t1/2) of IBI110+Sintilimab+EP
Time Frame: Up to 1 year
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Up to 1 year
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To assess the clearance(CL) of IBI110+Sintilimab+EP
Time Frame: Up to 1 year
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Up to 1 year
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To assess the volume of distribution(V) of IBI110+Sintilimab+EP
Time Frame: Up to 1 year
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Up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2021
Primary Completion (Actual)
February 16, 2023
Study Completion (Actual)
June 26, 2023
Study Registration Dates
First Submitted
August 16, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
Other Study ID Numbers
- CIBI110A201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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