Clinical Trial: NCT04836728
Phase II Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Tianjin Medical University Cancer Institute and Hospital |
| Information Provided By: | Tianjin Medical University Cancer Institute and Hospital |
| Last Update Posted: | 2025-03-13 |
Study Overview
Brief Summary
This prospective, multi-center, open-label, phase II, randomized controlled trial (CCICC-002b) is to evaluate the efficacy and safety of autologous cytokine-induced killer cell immunotherapy in combination with PD-1 inhibitor and platinum-containing chemotherapy in the first-line treatment of stage IV non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Multicenter, Open-label, Phase II Study of Platinum-Containing Chemotherapy and Sintilimab With or Without Autologous Cytokine-induced Killer Cell Immunotherapy in Stage IV Non-Small Cell Lung Cancer Subjects
Conditions
Non-small Cell Lung Cancer Metastatic, First-line Treatment
Intervention / Treatment
- Biological: CIK cells injection
- Drug: Sintilimab Injection
- Drug: Pemetrexed
- Drug: Albumin paclitaxel
- Drug: Carboplatin
Other Study ID Numbers
- E20210014
Start Date (Actual)
2021-03-31
Primary Completion Date (Actual)
2024-04-30
Study Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
156
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Tianjin Medical University Cancer Institute and Hospital |
| Information Provided By: | Tianjin Medical University Cancer Institute and Hospital |
| Last Update Posted: | 2025-03-13 |
Study Overview
Brief Summary
This prospective, multi-center, open-label, phase II, randomized controlled trial (CCICC-002b) is to evaluate the efficacy and safety of autologous cytokine-induced killer cell immunotherapy in combination with PD-1 inhibitor and platinum-containing chemotherapy in the first-line treatment of stage IV non-small cell lung cancer (NSCLC).
Official Title
A Randomized, Multicenter, Open-label, Phase II Study of Platinum-Containing Chemotherapy and Sintilimab With or Without Autologous Cytokine-induced Killer Cell Immunotherapy in Stage IV Non-Small Cell Lung Cancer Subjects
Conditions
Non-small Cell Lung Cancer Metastatic, First-line Treatment
Intervention / Treatment
- Biological: CIK cells injection
- Drug: Sintilimab Injection
- Drug: Pemetrexed
- Drug: Albumin paclitaxel
- Drug: Carboplatin
Other Study ID Numbers
- E20210014
Start Date (Actual)
2021-03-31
Primary Completion Date (Actual)
2024-04-30
Study Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
156
Study Type
Interventional
Phase
Phase 2