Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC
NCT07129161 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-08-19
Summary
This is a two-arm, randomized, multicenter phase II clinical study to evaluate the efficacy and safety of the Iparomlimab and Tuvonralimab combined with 2 or 4 cycles of chemotherapy as neoadjuvant therapy for resectable stage II-IIIB (N2 only) NSCLC.
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
- DRUG
-
4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 2 cycles (Platinum-based doublet chemotherapy)
Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w
- DRUG
-
4 cycles(Iparomlimab and Tuvonralimab 5mg/kg) + 4 cycles (Platinum-based doublet chemotherapy)
Iparomlimab and Tuvonralimab 5mg/kg:5mg/kg,q3W Platinum-based doublet chemotherapy:q3w
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-31
- Primary Completion
- 2026-10-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
More Related Trials
-
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
NCT04026412 ·Status: COMPLETED ·Phase: PHASE3
-
Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
NCT07349225 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Adebrelimab in Combination with Chemo with or Without Bevacizumab Neoadjuvant Therapy for Resectable NSCLC
NCT06775275 ·Status: RECRUITING ·Phase: PHASE2
-
Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer
NCT04506242 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
NCT02864251 ·Status: COMPLETED ·Phase: PHASE3
-
A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy
NCT04306042 ·Status: UNKNOWN
-
A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC
NCT07086326 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy and Biomarkers of the Second-line Treatment of Adebelizumab Combined With Irinotecan Liposome in Advanced Small Cell Lung Cancer
NCT07004712 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
NCT02659059 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
NCT04025879 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative
NCT04929041 ·Status: SUSPENDED ·Phase: PHASE2/PHASE3
-
Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)
NCT01454102 ·Status: COMPLETED ·Phase: PHASE1
-
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
NCT03663166 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
NCT06946797 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Accelerated Radio-Immunotherapy for Lung Cancer
NCT04577638 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC
NCT04324151 ·Status: RECRUITING
-
Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer
NCT07251582 ·Status: RECRUITING ·Phase: PHASE3
-
Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC
NCT02259621 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients
NCT04941417 ·Status: UNKNOWN ·Phase: PHASE2
-
Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer
NCT03158129 ·Status: COMPLETED ·Phase: PHASE2
-
Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer.
NCT03262779 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer
NCT06743581 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
NCT06241807 ·Status: RECRUITING ·Phase: PHASE2
-
Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
NCT03043599 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)
NCT07169708 ·Status: RECRUITING