Clinical trial

A Randomized, Open-label, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

ID

Name

CIBI110C201

Description

The main purpose of this study is to evaluate the neoadjuvant therapy efficacy of IBI110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pCR) rate in stage IIB (primary tumor \> 4 cm ) to IIIB (N2 only) subjects with radically resectable NSCLC.

Trial arms

Trial start

2021-12-02

Estimated PCD

2021-12-31

Trial end

2023-12-25

Status

Terminated

Phase

Early phase I

Treatment

IBI110

R2PD d1 IV every 3 weeks

Arms:

IBI110+sintilimab

sintilimab

200mg d1 IV every 3 weeks

Arms:

IBI110+sintilimab, sintilimab

Size

6

Primary endpoint

pCR

Approximately 21 to 28 days after operation

Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)

up to 90 days after the last administration

Number of participants with abnormality in vital signs

up to 90 days after the last administration

Number of participants with abnormality in hematology parameters

up to 90 days after the last administration

Number of participants with abnormality in clinical chemistry parameters

up to 90 days after the last administration

Number of participants with abnormality in clinical chemistry parameters

up to 90 days after the last administration

Number of participants with abnormality in routine urinalysis parameters

up to 90 days after the last administration

Number of participants with abnormality in ECG parameters

up to 90 days after the last administration

Eligibility criteria

Inclusion Criteria: 1. Have NSCLC that has been classified as stage IIB (primary tumor \> 4 cm), IIIA, or IIIB (N2 only) per the 8th edition of TNM staging system of International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC). 2. Subjects with non-squamous NSCLC should undergo genetic testing to confirm the absence of epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements; 3. Eligible for radical resection (R0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery; 4. Have at least one measurable lesion per RECIST v1.1 criteria; 5. Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Exclusion Criteria: 1. Have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy. 2. Have been previously exposed to immune-mediated therapies, including but not limited to LAG-3 antibody drugs, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

Updated at

2024-01-16

1 organization

2 products

1 indication

Organization

Innovent Biologics (Suzhou)

Product

Product

Indication