A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

Study Overview

• Status: Completed
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Biological: IBI939; Biological: Sintilimab

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • Jilin Province Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed the Informed Consent Form;
2. Male or female ≥ 18 and≤75 years of age;
3. Life expectancy ≥ 12 weeks;
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
6. Histologically or cytologically confirmednon-small cell lung cancer

Exclusion Criteria:

1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI939 in combination with Sintilimab	Biological: IBI939; IBI939 injection; Biological: Sintilimab; Sintilimab injection
Active Comparator: sintilimab	Biological: Sintilimab; Sintilimab injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR)	Proportion of subjects with complete response(CR) or partial response(PR).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event		3 months
Progression-free survival(PFS)	The time from randomization to the first occurrence of objective disease progression or death	6 months
Overall Survival(OS)	The time from randomization to death due to any cause.	6 months
Disease Control Rate(DCR)	Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).	6 months
Duration of Response (DoR)	The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death.	6 months
Time to Objective Response(TTR)	Time from randomization to first objective tumor response (CR or PR).	6 months
Area under the plasma concentration-time curve (AUC)		24 hours
Maximum concentration (Cmax)		24 hours
Trough concentration (Cmin)		24 hours
Clearance (CL), 12. volume of distribution (V)		24 hours
Half-life (t1/2)		24 hours

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Investigators: Principal Investigator: Ying Cheng, Jilin Province Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CIBI939A102(Ib)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No