IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)

NCT05118334 | Completed Phase 1

• 1 other identifier: CIBI310H201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)

Conditions

NSCLC (Non-small-cell Lung Cancer)

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate(ORR)

  Investigator evaluated ORR per RECIST V1.1

  Up to 2 years

• Treatment Emergent Adverse Event (TEAE)

  Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;

  Up to 2 years

• Severe Adverse Event (SAE)

  Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;

  Up to 2 years

Secondary Outcomes (6)

• DOR

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Time to Response (TTR)

  Up to 2 years

Study Arms (4)

IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab

EXPERIMENTAL

The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Drug: Sintilimab; Drug: IBI310

IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab

EXPERIMENTAL

The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W\*4cycles,and then Sintilimab 200 mg IV, Q3W single until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Drug: Sintilimab; Drug: IBI310

IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab

EXPERIMENTAL

The test group will be treated with IBI310 1mg/kg IV, Q6W+ Sintilimab 200 mg IV, Q3Wuntil progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Drug: Sintilimab; Drug: IBI310

IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab

EXPERIMENTAL

The test group will be treated with IBI310 0.5mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Drug: Sintilimab; Drug: IBI310

Interventions

Sintilimab DRUG

(IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W)until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab

IBI310 DRUG

(IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W) until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab; IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab

Eligibility Criteria

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

You may not qualify if:

• Had tumors other than NSCLC within the past 5 years.
• Had allogeneic organ or stem cell transplantation.
• The presence of uncontrolled life-threatening illness
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
• HIV positive.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Other treatment contraindications.
• Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
• Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
• Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

Sponsors & Collaborators

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

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• Zhao Y, Chen X, Yao J, Long J, Mao Y, Wu D, Zang A, Zhao J, Liu Z, Meng R, Chen Y, Luo Y, Guo Q, Li L, Cui J. A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non-small-cell lung cancer who have progressed after anti-PD-1/L1 therapy. Cancer Med. 2024 Feb;13(3):e6855. doi: 10.1002/cam4.6855. Epub 2024 Jan 12.

  PMID: 38214075 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: November 12, 2021
• Primary Completion: July 31, 2022
• Study Completion: February 17, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)