NCT04258033CompletedPhase 2
A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG)
A Phase II, Open-label, Multicenter and Multi-cohorts Study to Evaluate the Efficacy and Safety of PLB1001 in Advanced Non-small Cell Lung Cancer With c-Met Dysregulation
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 145 (actual)
- First submitted
- 3 Feb 2020
- Start date
- 17 Jan 2020
- Primary completion date
- 14 May 2024
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability Company
- Diseases
- Lung cancer
- NCT number
- NCT04258033
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 145
- From 17 Jan 2020 to the primary completion date, 14 May 2024
- 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
- Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
- Major surgery within 4 weeks prior to starting PLB1001
- Previous anti-cancer and investigational agents within 2 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001
- Involved in other clinical trials \< 2 weeks prior to Day. If previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001.
Other illness
- Clinically significant, uncontrolled heart diseases Unstable angina History of documented congestive heart failure (New York Heart Association functional classification \> II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg Arrhythmias
Other
- Pregnant or nursing women
Who the study is looking for
- Signed Informed Consent Form
- Age≥18 years
- Histologically or cytologically confirmed advanced non-small cell lung cancer
- Must have evidence of c-Met dysregulation from the results of molecular pre-screening evaluations
- At least one measurable lesion as per RECIST v1.1
- Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
- ECOG Performance Status of 0-1.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.