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A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Primary Purpose

SCLC

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Carboplatin

Cisplatin

Etoposide

Sintilimab

IBI110

About this trial

This is an interventional treatment trial for SCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sintilimab+EP

IBI110+Sintilimab+EP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Overall Survival(OS)

OS: Defined as the time interval from ran domization to death.

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.

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.

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.

To assess the immunogenicity;

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);

To assess the Area under the plasma concentration versus time curve(AUC) of IBI110+Sintilimab+EP

To assess the Peak Plasma Concentration(Cmax) of IBI110+Sintilimab+EP

To assess the half-life(t1/2) of IBI110+Sintilimab+EP

To assess the clearance(CL) of IBI110+Sintilimab+EP

To assess the volume of distribution(V) of IBI110+Sintilimab+EP

Full Information

NCT ID

NCT05026593

First Posted

August 16, 2021

Last Updated

July 17, 2023

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05026593

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

February 16, 2023 (Actual)

Study Completion Date

June 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sintilimab+EP

Arm Type

Active Comparator

Arm Description

Arm Title

IBI110+Sintilimab+EP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin 75 mg/m^2 will be administered after completion of Sintilimab by IV infusion on Day 1.

Intervention Type

Drug

Intervention Name(s)

Etoposide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .

Intervention Type

Drug

Intervention Name(s)

IBI110

Intervention Description

IBI110 RP2D will be administered by IV infusion on Day 1 of each 21-day .

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

Up to 5 years

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Overall Survival(OS)

Description

OS: Defined as the time interval from ran domization to death.

Time Frame

Up to 5 years

Title

Objective response rate(ORR)

Description

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

Title

Disease control rate(DCR);

Description

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

Title

Duration of response(DOR);

Description

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

Title

To assess the immunogenicity;

Description

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

Title

To assess the Area under the plasma concentration versus time curve(AUC) of IBI110+Sintilimab+EP

Time Frame

Up to 1 year

Title

To assess the Peak Plasma Concentration(Cmax) of IBI110+Sintilimab+EP

Time Frame

Up to 1 year

Title

To assess the half-life(t1/2) of IBI110+Sintilimab+EP

Time Frame

Up to 1 year

Title

To assess the clearance(CL) of IBI110+Sintilimab+EP

Time Frame

Up to 1 year

Title

To assess the volume of distribution(V) of IBI110+Sintilimab+EP

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Shanghai Pulmonary Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

NO.507,Zhengmin Road,Yangpu

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

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