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

NCT05026593 | Completed Phase 1

• 1 other identifier: CIBI110A201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

SCLC

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 5 years

Secondary Outcomes (10)

• Overall Survival(OS)

  Up to 5 years

• Objective response rate(ORR)

  Up to 5 years

• Disease control rate(DCR);

  Up to 5 years

• Duration of response(DOR);

  Up to 5 years

• To assess the immunogenicity;

  Up to 5 years

Study Arms (2)

Sintilimab+EP

ACTIVE COMPARATOR

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.

Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Sintilimab

IBI110+Sintilimab+EP

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Drug: Sintilimab; Drug: IBI110

Interventions

Carboplatin 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.

IBI110+Sintilimab+EP; Sintilimab+EP

Cisplatin DRUG

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

IBI110+Sintilimab+EP; Sintilimab+EP

Etoposide 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.

IBI110+Sintilimab+EP; Sintilimab+EP

Sintilimab DRUG

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

IBI110+Sintilimab+EP; Sintilimab+EP

IBI110 DRUG

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

IBI110+Sintilimab+EP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, NO.507,Zhengmin Road,Yangpu, China

Location

MeSH Terms

Interventions

Carboplatin; Cisplatin; Etoposide; sintilimab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 30, 2021
• Study Start: September 7, 2021
• Primary Completion: February 16, 2023
• Study Completion: June 26, 2023
• Last Updated: July 19, 2023

Record last verified: 2022-07

Locations

CN (1)