NSCLCPhase 2NCT07670013
SKB264 Plus Glecirasib in Advanced KRAS G12C-Mutant NSCLC: A Phase II Study
A Phase 2 study testing SKB264 and Goleirex in people with NSCLC, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SKB264 and Goleirex
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent form (ICF).
- Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.
- Expected survival time of ≥3 months.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with unresectable locally advanced stage (Stage ⅢB/ⅢC), metastatic or recurrent stage (Stage Ⅳ) that is not eligible for radical concurrent chemoradiotherapy, in accordance with the 8th edition of the TNM --Staging System for Lung Cancer by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
- Confirmed KRAS G12C mutation-positive by a qualified laboratory (CAP/CLIA or nationally accredited) using next-generation sequencing (NGS) or an equivalent method; positivity in either tissue samples or plasma circulating tumor DNA (ctDNA) is acceptable. If plasma testing is negative and tissue testing is feasible, supplementary tissue testing is recommended.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.
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- Definition for first-line systemic therapy of advanced disease: No prior systemic anti-tumor therapy for metastatic/advanced disease. For subjects who previously received radical post-surgical therapy, chemoradiotherapy or immunotherapy alone, enrollment is permitted only if the interval from the last dose to disease recurrence is ≥6 months.
- Presence of at least one measurable lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; measurable lesions within a prior radiotherapy field or after local treatment may be selected as target lesions if disease progression is documented.
- Sufficient organ and bone marrow function, including the following:
- Adequate hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥9 g/dL. No blood transfusion or treatment with granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), erythropoietin (EPO) or other similar agents is allowed within 14 days prior to blood routine testing.
- Adequate liver function: Total bilirubin (TBIL) <1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5×ULN; for subjects with Gilbert's syndrome, TBIL <2×ULN is acceptable; for subjects with liver metastases from tumor, AST and ALT <5.0×ULN is required; for subjects with extrahepatic obstruction confirmed by direct bilirubin (DBIL) testing, TBIL <3.0×ULN is permitted.
- Adequate renal function: Serum creatinine (Cr) ≤1.5×ULN, or if Cr >1.5×ULN, creatinine clearance (CrCl) ≥60 mL/min calculated by the Cockcroft-Gault formula.
- Adequate coagulation function: Prothrombin time (PT)/activated partial thromboplastin time (APTT) <1.5×ULN, and international normalized ratio (INR) <1.5 or within the target range for anticoagulant therapy.
- Serum magnesium level within the normal range.
- Toxic effects from prior anti-tumor therapy must have recovered to baseline levels (excluding residual alopecia) or grade ≤1 at enrollment (grade ≤2 neurotoxicity is acceptable). For immune-related adverse events (irAEs) involving the endocrine system caused by prior immunotherapy (e.g., immune-related hypothyroidism), subjects with well-controlled symptoms under stable-dose hormone replacement therapy or physiological-dose corticosteroid therapy may be enrolled if the investigator assesses that the treatment does not interfere with the administration of study drugs and safety evaluation.
- Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must adopt effective contraceptive measures from the time of signing the ICF until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative blood pregnancy test result within 7 days (inclusive) prior to the first dose of study drug. If a urine pregnancy test result is inconclusive, a blood pregnancy test is required.
- The investigator judges that the subject is capable of effective communication, complying with scheduled follow-up visits and completing the study in accordance with the protocol requirements.
Who cannot join
- Prior treatment with a KRAS G12C inhibitor or TROP2-ADC; any prior systemic anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, etc.) for advanced non-small cell lung cancer (NSCLC).
- Positive for other clinically approved first-line targetable oncogenic drivers: classic sensitizing EGFR mutations (19del/L858R), ALK/ROS1/RET/NTRK fusions, BRAF V600E mutation, MET exon 14 skipping mutation, and other mutations for which guideline-recommended approved first-line targeted therapies are available (to avoid conflict with current standard of care); concurrent mutations such as KRAS combined with STK11/KEAP1 are not exclusion criteria.
- Histologically or cytologically confirmed mixed NSCLC with small cell carcinoma components or predominantly squamous cell carcinoma components.
- Significant cardiovascular and cerebrovascular diseases, including:
- A confirmed major cardiovascular adverse event within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or receipt of angioplasty, vascular stenting, coronary artery bypass grafting, or other similar procedures; -Clinically significant prolonged QT/QTcF interval on electrocardiogram (QTcF >470 ms in females or QTcF >450 ms in males); A confirmed major cerebrovascular adverse event within 3 months, such as intracerebral hemorrhage or cerebral infarction.
- Uncontrolled central nervous system (CNS) disease: active CNS metastases requiring urgent local therapy; meningeal carcinomatosis.
- -Interstitial lung disease (ILD)/drug-induced pneumonitis: active ILD/pneumonitis or a history of ILD/pneumonitis requiring systemic corticosteroid therapy; baseline chest imaging showing active ILD-like changes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Xia Yang, PhD, +86 18868439669, yxia@zju.edu.cn
About this study
Official title: A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC
This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.
- Conditions
- NSCLC
- Being tested
- SKB264, Goleirex
- Keywords
- SBK264, Goleirex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
4 mg/kg intravenously every 2 weeks
GoleirexDrug
600 mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| SKB264 + Goleirex | Experimental | Patients with KRAS G12C-mutated advanced non-squamous non-small cell lung cancer (NSCLC) receive first-line treatment with SKB264 in combination with Glecirasib (a KRAS G12C inhibitor). The therapeutic efficacy and safety of this combination regimen will be evaluated throughout the study. Receives: Drug: SKB264; Drug: Goleirex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate as Assessed by RECIST v1.1
Objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR) as assessed by RECIST v1.1.
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (1)
Progression-free Survival as Assessed by RECIST v1.1
Progression-free survival (PFS) refers to the period from the start of combined treatment until any objectively recorded tumor progression occurs or until the patient's death (for patients lost to follow-up, it is the last follow-up time; for patients still alive at the end of the study, it is the date of the follow-up termination) as assessed by RECIST v1.1.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of University of Science and Technology of China, Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670013
- Sponsor's protocol ID
- 2025-1542
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC
- ClinicalTrials.gov ID
- NCT07670013
- Acronym / sponsor ID
- 2025-1542
- Conditions
- NSCLC
- Keywords
- SBK264, Goleirex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of University of Science and Technology of China, Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB264 + Goleirex | Experimental | Drug: SKB264, Drug: GoleirexPatients with KRAS G12C-mutated advanced non-squamous non-small cell lung cancer (NSCLC) receive first-line treatment with SKB264 in combination with Glecirasib (a KRAS G12C inhibitor). The therapeutic efficacy and safety of this combination regimen will be evaluated throughout the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntarily participate in the study and sign the informed consent form (ICF).
- Male or female subjects aged ≥18 years and ≤75 years at the time of signing the ICF.
- Expected survival time of ≥3 months.
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with unresectable locally advanced stage (Stage ⅢB/ⅢC), metastatic or recurrent stage (Stage Ⅳ) that is not eligible for radical concurrent chemoradiotherapy, in accordance with the 8th edition of the TNM --Staging System for Lung Cancer by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
- Confirmed KRAS G12C mutation-positive by a qualified laboratory (CAP/CLIA or nationally accredited) using next-generation sequencing (NGS) or an equivalent method; positivity in either tissue samples or plasma circulating tumor DNA (ctDNA) is acceptable. If plasma testing is negative and tissue testing is feasible, supplementary tissue testing is recommended.
Key exclusion criteria (7 listed)
- Prior treatment with a KRAS G12C inhibitor or TROP2-ADC; any prior systemic anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, etc.) for advanced non-small cell lung cancer (NSCLC).
- Positive for other clinically approved first-line targetable oncogenic drivers: classic sensitizing EGFR mutations (19del/L858R), ALK/ROS1/RET/NTRK fusions, BRAF V600E mutation, MET exon 14 skipping mutation, and other mutations for which guideline-recommended approved first-line targeted therapies are available (to avoid conflict with current standard of care); concurrent mutations such as KRAS combined with STK11/KEAP1 are not exclusion criteria.
- Histologically or cytologically confirmed mixed NSCLC with small cell carcinoma components or predominantly squamous cell carcinoma components.
- Significant cardiovascular and cerebrovascular diseases, including:
- A confirmed major cardiovascular adverse event within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or receipt of angioplasty, vascular stenting, coronary artery bypass grafting, or other similar procedures; -Clinically significant prolonged QT/QTcF interval on electrocardiogram (QTcF >470 ms in females or QTcF >450 ms in males); A confirmed major cerebrovascular adverse event within 3 months, such as intracerebral hemorrhage or cerebral infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB2644 mg/kg intravenously every 2 weeks | Drug | SKB264 + Goleirex |
| Goleirex600 mg orally once daily | Drug | SKB264 + Goleirex |
Primary outcome
Objective Response Rate as Assessed by RECIST v1.1
Time frame: From enrollment to the end of treatment at 12 months
Objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR) as assessed by RECIST v1.1.
1 secondary outcome
Progression-free Survival as Assessed by RECIST v1.1
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB264 and Goleirex in people with NSCLC, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xia, MD，PhD (+8618868439669, yxia@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate as Assessed by RECIST v1.1 (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.