NCT05504278RecruitingPhase 1
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 11 Aug 2022
- Start date
- 20 Sept 2022
- Primary completion date
- 31 May 2025
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT05504278
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 144
- From 20 Sept 2022 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
Other illness
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
Other
- Active brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jilin Province Cancer Hospital Coordinator of this site? Confirm its status | Jilin City | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.