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

Primary Purpose

NSCLC (Non-small-cell Lung Cancer)

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Sintilimab

IBI310

About this trial

This is an interventional treatment trial for NSCLC (Non-small-cell Lung Cancer)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria:

Aged ≥18 years;
ECOG 0 ~ 1;
Histologically /cytologically confirmed R/M NSCLC;
Adequate organ and bone marrow function;
Expected survival ≥12 weeks;
Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria:

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.

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR)

Investigator evaluated ORR per RECIST V1.1

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;

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;

Secondary Outcome Measures

DOR

Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;

Progression Free Survival (PFS)

Defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;

Overall Survival (OS)

Defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced NSCLC

Disease Control Rate (DCR)

Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD

Time to Response (TTR)

Defined as the time from randomization to the first documented and confirmed objective response (CR or PR)

HRQoL

According to EORTC QLQ-C30

Full Information

NCT ID

NCT05118334

First Posted

November 1, 2021

Last Updated

February 22, 2023

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05118334

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 12, 2021 (Actual)

Primary Completion Date

July 31, 2022 (Actual)

Study Completion Date

February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC (Non-small-cell Lung Cancer)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

(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.

Intervention Type

Drug

Intervention Name(s)

IBI310

Intervention Description

(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.

Primary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Description

Investigator evaluated ORR per RECIST V1.1

Time Frame

Up to 2 years

Title

Treatment Emergent Adverse Event (TEAE)

Description

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;

Time Frame

Up to 2 years

Title

Severe Adverse Event (SAE)

Description

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;

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

DOR

Description

Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;

Time Frame

Up to 2 years

Title

Progression Free Survival (PFS)

Description

Defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;

Time Frame

Up to 2 years

Title

Overall Survival (OS)

Description

Defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced NSCLC

Time Frame

Up to 2 years

Title

Disease Control Rate (DCR)

Description

Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD

Time Frame

Up to 2 years

Title

Time to Response (TTR)

Description

Defined as the time from randomization to the first documented and confirmed objective response (CR or PR)

Time Frame

Up to 2 years

Title

HRQoL

Description

According to EORTC QLQ-C30

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: Aged ≥18 years; ECOG 0 ~ 1; Histologically /cytologically confirmed R/M NSCLC; Adequate organ and bone marrow function; Expected survival ≥12 weeks; Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration; Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1). Exclusion Criteria: 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.

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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