IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)
NCT ID: NCT05118334
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2021-11-12
2023-02-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC
NCT04945421
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
NCT03545971
Safety and Tolerability Evaluation of Sintilimab in Combination With Radiation in Stage IV NSCLC Patients
NCT03812549
Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
NCT03607539
A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer
NCT04672356
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with 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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
2. Had allogeneic organ or stem cell transplantation.
3. The presence of uncontrolled life-threatening illness
4. 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.
5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
6. HIV positive.
7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
8. Severe, uncontrolled medical conditions and infections.
9. At the same time using other test drugs or in other clinical trials.
10. Refusal or inability to sign informed consent to participate in the trial.
11. Other treatment contraindications.
12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Hospital of Jilin University
Changchun, Jilin, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIBI310H201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.