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Advanced Non-Small Cell Lung CancerPhase 1NCT05504278

Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

A Phase 1 study testing IBI351, Cetuximab and pemetrexed in people with Advanced Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site 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
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Trial summary

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
IBI351, Cetuximab and pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
20 Sep 2022to 31 Jul 2027
Phase
Phase 1
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

  • Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
  • Unresectable or metastatic disease
  • Adequate organ function
  • Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

Who cannot join

  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
  • Active brain metastases.

Trial locations and contacts

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

Haiyan Zhu contact

0512-69566088

haiyan.zhu@innoventbio.com

China1 site, 1 recruiting

  • Jilin Province Cancer Hospital

    Jilin City, Changchun

    Ying Cheng, 0431-80596315, jl.cheng@163.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.

Read the detailed description

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy. There will be five cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Those five cohorts (A, B,C ,D and E) are treated with IBI351, IBI351+Sintilimab,IBI351+pemetrexed+cis-platinum/carboplatin,IBI351+Cetuximab, or IBI351+pemetrexed+cis-platinum/carboplatin respectively.

IBI351 is an orally available small molecule inhibitor of KRAS G12C.

What participants receive

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

  • IBI351Drug

    Also called GFH925

    recommended dose, po

  • CetuximabDrug

    500mg/m^2, Q2W, day1, i.v.

  • pemetrexedDrug

    500mg/m^2, Q3W, day1, i.v.

  • CarboplatinDrug

    AUC=5, Q3W, day1, i.v.

  • SintilimabDrug

    Also called IBI308

    200mg, Q3W, day1, i.v.

  • cis-platinumDrug

    75mg/m^2, Q3W, day1, i.v.

Study groups in NCT05504278
Study groupRoleWhat they receive
IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%)ExperimentalNot described
Receives: Drug: IBI351; Drug: pemetrexed; Drug: Carboplatin; Drug: cis-platinum
IBI351 in combination with CetuximabExperimentalNot described
Receives: Drug: IBI351; Drug: Cetuximab
IBI351 monotherapyExperimentalNot described
Receives: Drug: IBI351
IBI351 in combination with SintilimabExperimentalNot described
Receives: Drug: IBI351; Drug: Sintilimab
IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)ExperimentalNot described
Receives: Drug: IBI351; Drug: pemetrexed; Drug: Carboplatin; Drug: cis-platinum

What is being measured

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

  1. Number of participants with dose limiting toxicity

    Number of participants with dose limiting toxicity in the dose escalation period

    Measured: 12 months

  2. Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents

    Objective response rate per RECIST v1.1

    Measured: 24 months

  3. Safety indicators during the introduction phase for IBI351 combination treatment :

    Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram

    Measured: 24 months

Secondary outcomes (11)

  1. Evaluate plasma peak concentration of IBI351

    Cmax

    Measured: 12 months

  2. Evaluate area under the plasma concentration-time curve (AUC) of IBI351

    AUC

    Measured: 12 months

  3. Evaluate terminal half-life (t1/2) of IBI351

    t1/2

    Measured: 12 months

  4. Evaluate clearance of IBI351 from the plasma

    CL/F

    Measured: 12 months

  5. Evaluate distribution of IBI351

    V/F

    Measured: 12 months

  6. Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents with other index

    PFS, DCR,DOR, TTR per RECIST v1.1; OS

    Measured: 24 months

  7. Number of subjects with adverse events of interest

    AE

    Measured: 24 months

  8. Number of subjects with treatment-related adverse events

    TRAE

    Measured: 24 months

  9. Number of subjects with serious adverse events

    SAE

    Measured: 24 months

  10. Number of subjects with treatment-emergent adverse events

    TEAE

    Measured: 24 months

  11. Overall Survival

    OS

    Measured: 24 months

Timeline

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

  1. First posted17 Aug 2022
  2. Study start20 Sep 2022
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 Jul 2027 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504278
Sponsor's protocol ID
CIBI351A301
Status last verified
Jan 2025
First submitted
11 Aug 2022
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI351, Cetuximab and pemetrexed in people with Advanced Non-Small Cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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 4 inclusion and 3 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 27 Jan 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Haiyan Zhu (0512-69566088, haiyan.zhu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose limiting toxicity (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05504278.

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 27 Jan 2025.

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