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

NCT ID: NCT04672369

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-06
• Study Completion Date: 2023-06-01

Brief Summary

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.

Conditions

Advanced Lung Cancer

Study Design

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

Study Groups

IBI939 in combination with Sintilimab

Group Type: EXPERIMENTAL

IBI939

Intervention Type: BIOLOGICAL

IBI939 injection

Sintilimab

Intervention Type: BIOLOGICAL

Sintilimab injection

sintilimab

Group Type: ACTIVE_COMPARATOR

Sintilimab

Intervention Type: BIOLOGICAL

Sintilimab injection

Interventions

IBI939

IBI939 injection

Intervention Type: BIOLOGICAL

Sintilimab

Sintilimab injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Cheng

Role: PRINCIPAL_INVESTIGATOR

Jilin Province Cancer Hospital

Locations

Jilin Province Cancer Hospital

Jilin, , China

Countries

China

Other Identifiers

CIBI939A102(Ib)

Identifier Type: -

Identifier Source: org_study_id