IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)
- Conditions
- NSCLC (Non-small-cell Lung Cancer)
- Interventions
- Drug: IBI310
- Registration Number
- NCT05118334
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab IBI310 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. IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab 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. IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab IBI310 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. IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab IBI310 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. IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab IBI310 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. IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab Sintilimab 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. IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab 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. IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method HRQoL Up to 2 years According to EORTC QLQ-C30
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)
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China