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

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05118334

Collaborator

(none)

Enrollment

Location

Arms

19.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
NSCLC (Non-small-cell Lung Cancer)	Drug: Sintilimab Drug: IBI310	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Nov 24, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab 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 (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: IBI310 (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.
Experimental: IBI310 (anti-CTLA-4) 1mg/kg(Q3W4cycles)in combination with Sintilimab The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W4cycles,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 (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: IBI310 (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.
Experimental: IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab 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 (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: IBI310 (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.
Experimental: IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab 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 (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: IBI310 (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.

Outcome Measures

Primary Outcome Measures

Objective Response Rate(ORR) [Up to 2 years]
Investigator evaluated ORR per RECIST V1.1
Treatment Emergent Adverse Event (TEAE) [Up to 2 years]
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) [Up to 2 years]
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 [Up to 2 years]
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) [Up to 2 years]
Defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;
Overall Survival (OS) [Up to 2 years]
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) [Up to 2 years]
Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
Time to Response (TTR) [Up to 2 years]
Defined as the time from randomization to the first documented and confirmed objective response (CR or PR)
HRQoL [Up to 2 years]
According to EORTC QLQ-C30

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Jilin University	Changchun	Jilin	China	130021

Sponsors and Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Innovent Biologics (Suzhou) Co. Ltd.

ClinicalTrials.gov Identifier:

NCT05118334

Other Study ID Numbers:

CIBI310H201

First Posted:

Nov 11, 2021

Last Update Posted:

Feb 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Feb 15, 2022