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

NCT ID: NCT05026593

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2023-06-26

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.

Conditions

SCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

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

Intervention Type: DRUG

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

IBI110

Intervention Type: DRUG

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

Interventions

Carboplatin

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

Cisplatin

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

Intervention Type: DRUG

Etoposide

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

Sintilimab

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

Intervention Type: DRUG

IBI110

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CIBI110A201

Identifier Type: -

Identifier Source: org_study_id