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Lung Cancer (Non-Small Cell)Phase 2NCT07198841

IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

A Phase 2 study testing IBI351 combined with cetuximab β in people with Lung Cancer (Non-Small Cell), run by Guangdong Association of Clinical Trials at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study Design: a Phase II, single-arm, multicenter, prospective, interventional study. Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer (Non-Small Cell)
What is being tested?
IBI351 combined with cetuximab β
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
7 sitesChina
Study dates
3 Nov 2025to Sep 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.
  • Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB/IIIC), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC), per the International Association for the Study of Lung Cancer (IASLC) and American Joint Committee on Cancer (AJCC) 8th edition TNM staging, and not candidates for curative concurrent chemoradiotherapy.
  • Documented KRAS G12C mutation confirmed by a written report from a certified laboratory.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
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  • No prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC. Subjects who received prior adjuvant therapy are eligible provided disease recurrence occurred ≥6 months after the last dose of adjuvant therapy or the last session of radical radiotherapy.
  • At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions within a prior radiation field or after local therapy can be considered target lesions if documented progression is evident.
  • Adequate organ and bone marrow function, defined as:
  • 1）Hematopoietic: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 9 g/dL. No transfusion or treatment with granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin within 14 days prior to hematology tests.
  • 2）Hepatic: 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, AST and ALT < 5.0 × ULN is required. If direct bilirubin (DBIL) suggests extrahepatic obstruction, TBIL < 3.0 × ULN is permitted.
  • 3）Renal: Serum creatinine (Cr) ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula) if Cr > 1.5 × ULN.
  • 4）Coagulation: Prothrombin time (PT) / activated partial thromboplastin time (APTT) < 1.5 × ULN and international normalized ratio (INR) < 1.5 or within the therapeutic range for subjects on anticoagulation therapy.
  • 5）Magnesium: Serum magnesium within normal limits. 10. Toxicities from prior anti-tumor therapy must have resolved to baseline or ≤ Grade 1 (except for residual alopecia; neurotoxicity ≤ Grade 2 is acceptable). Subjects with prior immune-related endocrine adverse events (irAEs) from immunotherapy (e.g., hypothyroidism) that are asymptomatic and stably controlled with ongoing hormone replacement or physiologic doses of corticosteroids may be enrolled if the investigator judges that this will not affect study drug administration or safety assessment.
  • 11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception from signing the ICF until 6 months after the last dose of study drug. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days (inclusive) prior to the first dose. If a urine pregnancy test result is inconclusive, a serum pregnancy test is required.

Who cannot join

  • Histologically or cytologically confirmed NSCLC with mixed small cell components or predominantly squamous cell carcinoma components.
  • Presence of EGFR sensitizing mutation, ALK rearrangement, ROS-1 fusion, or other genomic alterations for which NMPA-approved first-line NSCLC therapies exist.
  • Significant cardiovascular or cerebrovascular disease, including:
  • 1）Clinically significant cardiovascular events within 6 months (e.g., myocardial infarction, angina, heart failure, severe arrhythmia) or history of angioplasty, stenting, or coronary artery bypass grafting.
  • 2）Clinically significant prolongation of the QTcF interval (QTcF > 470 ms for females or > 450 ms for males).
  • 3）Clinically significant cerebrovascular events within 3 months (e.g., cerebral hemorrhage, infarction).
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  • 4. Active central nervous system (CNS) metastases (e.g., brain or leptomeningeal metastases). Subjects with previously treated brain metastases may be eligible if they are asymptomatic for at least 7 days after completion of radiotherapy/local therapy without requiring steroids/anti-epileptics, OR off steroids/anti-epileptics for at least 7 days, AND judged by the investigator to have stable CNS disease.
  • 5. Clinically significant interstitial lung disease (ILD), radiation pneumonitis, or drug-induced pneumonitis requiring treatment; active pulmonary tuberculosis; pneumoconiosis; Grade ≥2 pneumonitis of other etiologies; or severely impaired pulmonary function (FEV1 or DLCO or DLCO/VA <40% of predicted value).
  • 6. Significant gastrointestinal disorders affecting drug absorption or swallowing (e.g., refractory hiccups, nausea, vomiting, severe peptic ulcer disease, liver cirrhosis, active GI bleeding).
  • 7. Major active or chronic infections, including:
  • Active infection requiring systemic therapy.
  • Baseline positive HIV antibody (HIV-Ab); acute or chronic active hepatitis B (defined as HBsAg and/or HBcAb positive AND HBV-DNA > 2500 copies/mL or 500 IU/mL); or acute or chronic active hepatitis C (HCV antibody positive AND HCV-RNA above the lower limit of quantification).
  • Active pulmonary tuberculosis. 8. Symptomatic pleural, peritoneal, or pericardial effusions requiring repeated drainage.
  • 9. Poorly controlled systemic diseases despite standard therapy (e.g., hypertension: systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg; diabetes).
  • 10. History of other active malignancies within 2 years prior to study entry, except appropriately treated carcinoma in situ of the cervix, localized squamous cell carcinoma of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma in situ of the breast, and superficial non-muscle invasive urothelial carcinoma.
  • 11. Prior treatment with any KRAS G12C inhibitor. 12. Prior treatment with cetuximab or its analogues. 13. Systemic treatment with Chinese herbal medicine with anti-tumor indications within 1 week prior to the first dose, OR systemic treatment with immunomodulatory drugs (including thymosin, interferon, interleukin; except for localized intrapleural use for effusion control) within 2 weeks prior to the first dose.
  • 14. Therapeutic or palliative radiotherapy (except cranial radiotherapy) or local therapy within 14 days prior to the first study dose.
  • 15. Any other anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, investigational drug/device) within 28 days or 5 half-lives (whichever is shorter) prior to the first study dose.
  • 16. Major surgery within 28 days prior to study entry that could affect study drug administration or assessments (excluding diagnostic biopsy).
  • 17. Use of known sensitive substrates of CYP2D6, CYP3A4, P-gp, or BCRP with a narrow therapeutic window within 14 days or 5 half-lives (whichever is longer) prior to the first study dose, unless agreed upon by both the investigator and sponsor.
  • 18. Concurrent participation in another interventional clinical trial (participation in observational studies or the follow-up phase of an interventional study is permitted).
  • 19. Use of immunosuppressive drugs within 4 weeks prior to the first study dose, excluding intranasal, inhaled, or topical corticosteroids; systemic corticosteroids at physiologic doses (≤10 mg/day prednisone or equivalent); or corticosteroids administered for prophylaxis of contrast media allergy.
  • 20. Administration of live attenuated vaccines within 4 weeks prior to the first study dose or planned during the study period.
  • Note: Inactivated seasonal influenza vaccines administered >4 weeks prior are allowed; live attenuated influenza vaccines are not permitted.
  • 21. Known or suspected autoimmune disease, or history of autoimmune disease within 2 years prior to screening (subjects with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy in the last 2 years, hypothyroidism managed only with hormone replacement, or type 1 diabetes managed only with insulin replacement are eligible).
  • 22. Known history of primary immunodeficiency. 23. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • 24. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to enrollment (implant port- or catheter-related thrombosis, or superficial venous thrombosis are not considered "severe").
  • 25. Known hypersensitivity to any component of the study drug or its formulation.
  • 26. Pregnant or breastfeeding women. 27. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qing Zhou, PhD contact

+86 20 83827812

gzzhouqing@126.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Chinese PLA General Hospital

    Beijing

    Yi Hu, 010-68182255, huyi0401@aliyun.com

    Yi Hu

    Recruiting

  • The First People's Hospital of Foshan

    Foshan

    Wei-Neng Feng, 0757-83163168, fengweineng@163.com

    Wei-Neng Feng

    Recruiting

  • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University,

    Guangzhou, Guangdong, 510080

    Qing Zhou, PhD, 020-83827812, gzzhouqing@126.com

    Qing Zhou

    Recruiting

  • The first affiliated hospital of nanchang university

    Nanchang

    Long-Hua Sun, 0791-88692748, ndyfy05715@ncu.edu.cn

    Long-Hua Sun

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    An-Wen Liu, 0791-86120120, liuanwen999@126.com

    An-Wen Liu

    Recruiting

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning

    Qi-Tao Yu, 0771-5331955, yqt178@163.com

    Qi-Tao Yu

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

    Jian Shi, 0311-86095200, shijian6668@126.com

    Jian Shi

    Not yet recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study

Study Design: a Phase II, single-arm, multicenter, prospective, interventional study.

Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation.

Read more

Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity.

Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.

Being tested
IBI351 combined with cetuximab β
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI351 combined with cetuximab βDrug

    Subjects will receive treatment with IBI351 plus cetuximab β, consisting of oral IBI351 administered at 600 mg twice daily (BID) either in a fasting or fed state, combined with intravenous infusion of cetuximab β injection dosed at 500 mg/m² (body surface area) every two weeks. Each treatment cycle spans two weeks. Therapy will continue until disease progression, unacceptable toxicity, or meeting other protocol-defined criteria for treatment discontinuation-whichever occurs first. Dose adjustments may be implemented throughout the study based on drug-related toxicities.

Study groups in NCT07198841
Study groupRoleWhat they receive
IBI351+ cetuximab β treatmentExperimentalNot described
Receives: Drug: IBI351 combined with cetuximab β

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The proportion of patients achieving complete and partial response after treatment, measured according to RECIST v1.1 criteria

    Measured: From the first dose of treatment to disease progression or death, whichever comes first, up to 2 years

Secondary outcomes (5)

  1. Progression-Free Survival

    Progression-free survival is defined as the time from first dose of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1 criteria

    Measured: From the first dose of treatment until the first documentation of disease progression or death from any cause, whichever occurs first (up to 2 years)

  2. Time To Response

    Time from the first administration of the drug to the first assessment by the investigator using RECIST 1.1 criteria as Complete Response or Partial Response

    Measured: From the first dose to disease progression or death, whichever comes first, up to 2 years

  3. Disease Control Rate

    Disease control rate is defined as the proportion of participants with complete response, partial response, and stable disease, as determined by RECIST v1.1 criteria

    Measured: From the first dose to disease progression or death, whichever comes first, up to 2 years

  4. Overall Survival

    The time from the first administration of treatment to death due to any reason

    Measured: From the first dose of treatment to death due to any reason, whichever comes first, up to 2 years

  5. Adverse Events

    Assessed by recording treatment-related adverse events and serious adverse events , graded according to the CTCAE version 5.0

    Measured: From the first dose of treatment to disease progression or death (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start3 Nov 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07198841
Sponsor's protocol ID
CTONG2506
Status last verified
Nov 2025
First submitted
27 Aug 2025
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI351 combined with cetuximab β in people with Lung Cancer (Non-Small Cell), run by Guangdong Association of Clinical Trials at 7 sites 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 15 inclusion and 29 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 Qing Zhou, PhD (+86 20 83827812, gzzhouqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: From the first dose of treatment to disease progression or death, whichever comes first, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198841.

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 11 Mar 2026.

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