A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation
NCT06936644 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2025-04-20
Summary
A multicenter, single-arm Phase II study to evaluate the efficacy and safety of fulzerasib (IBI351) in combination with ivonescimab (AK-112) in first-line treatment of advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
Conditions
- KRAS G12C Lung Cancer
Interventions
- DRUG
-
IBI351+AK112
The advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation will receive the combination of fulzerasib (IBI351) with ivonescimab (AK-112) in first-line treatment
Sponsors & Collaborators
- collaborator OTHER
-
Akesobio
collaborator INDUSTRY -
Shanghai Chest Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2027-04-30
- Completion
- 2028-03-30
More Related Trials
-
Phase I Multicenter Trial Combining Nivolumab, Ipilimumab and Hypo-fractionated Radiotherapy for Pretreated Advanced Stage Non-small Cell Lung Cancer Patients
NCT03509584 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
NCT04647344 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC
NCT07086326 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer
NCT03866993 ·Status: COMPLETED ·Phase: PHASE3
-
AK112 in Advanced Non-Small Cell Lung Cancer
NCT05499390 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
KRAS-Targeted Vaccine With Chemoimmunotherapy, Nivolumab and Ipilimumab for Patients With NSCLC
NCT05254184 ·Status: RECRUITING ·Phase: PHASE1
-
Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%
NCT07215962 ·Status: ACTIVE_NOT_RECRUITING
-
Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC
NCT05400577 ·Status: WITHDRAWN ·Phase: PHASE2
-
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation
NCT07012031 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
NCT05920356 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer
NCT05088967 ·Status: TERMINATED ·Phase: PHASE1
-
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
NCT06343402 ·Status: RECRUITING ·Phase: PHASE1
-
AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT05904379 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/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
-
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
-
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
NCT01218516 ·Status: COMPLETED ·Phase: PHASE2
-
Iparomlimab and Tuvonralimab Combined With 2 or 4 Cycles of Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC
NCT07129161 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Chemotherapy Combined with ICIs in First-line Alectinib Failed Patients with ALK-rearranged NSCLC
NCT04997382 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
NCT05118854 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ivarmacitinib in Advanced Solid Tumors: A Prospective, Two-Cohort, Two-Phase Exploratory Study in Patients Discontinued Due to Immune Intolerance
NCT07313202 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
NCT03472053 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets
NCT07234877 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Study to Evaluate KOS-1584 in Patients With Advanced or Metastatic Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
NCT00651508 ·Status: COMPLETED ·Phase: PHASE2
-
Chemoradiotherapy of NSCLC Stage IIIB
NCT00198432 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer
NCT01820325 ·Status: TERMINATED ·Phase: PHASE1