NCT05504278 Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
| NCT ID | NCT05504278 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Advanced Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2022-09-20 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 144 participants in total. It began in 2022-09-20 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation 2. Unresectable or metastatic disease 3. Adequate organ function 4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously. Exclusion Criteria: 1. History of intestinal disease or major gastric surgery or inability to swallow oral medications 2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510). 3. Active brain metastases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05504278 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05504278 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05504278 currently recruiting?
Yes, NCT05504278 is actively recruiting participants. Contact the research team at haiyan.zhu@innoventbio.com for enrollment information.
Where is the NCT05504278 trial being conducted?
This trial is being conducted at Jilin City, China.
Who is sponsoring the NCT05504278 clinical trial?
NCT05504278 is sponsored by Innovent Biologics (Suzhou) Co. Ltd.. The trial plans to enroll 144 participants.
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