Clinical trial NCT05088967: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: pCR
timeFrame: Approximately 21 to 28 days after operation
measure: Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in vital signs
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in hematology parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in clinical chemistry parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in clinical chemistry parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in routine urinalysis parameters
timeFrame: up to 90 days after the last administration
measure: Number of participants with abnormality in ECG parameters
timeFrame: up to 90 days after the last administration
Secondary outcomes:
measure: EFS （Event Free Survival）
timeFrame: up to 3 years
measure: major pathological response (MPR) rate
timeFrame: Approximately 21 to 28 days after operation
measure: radical resection (R0 resection) rate
timeFrame: Approximately 21 to 28 days after operation
measure: ORR （Objective Response rate,）
timeFrame: Within 7 days before surgery
measure: OS （Overall Survival）
timeFrame: up to 3 years
measure: Immunogenicity
timeFrame: From date of randomization to 30 days after last dose of the drug
measure: maximum concentrations (Cmax )
timeFrame: from first administration of IBI110 to 3 days before the operation
measure: the area under the drug plasma concentration-time curve (AUC)
timeFrame: from first administration of IBI110 to 3 days before the operation
measure: half-life (t1/2)
timeFrame: from first administration of IBI110 to 3 days before the operation
measure: clearance (CL)
timeFrame: from first administration of IBI110 to 3 days before the operation
measure: volume of distribution (V).
timeFrame: from first administration of IBI110 to 3 days before the operation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: