New pill shows promise against tough lung cancer in early trial
NCT ID NCT04258033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an oral drug called PLB1001 in 145 people with advanced non-small cell lung cancer whose tumors have a specific genetic change (c-Met dysregulation). The main goal was to see how many patients' tumors shrank or disappeared. The drug is taken twice daily and aims to control the disease, not cure it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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145 people
The number who actually took part.
- Started
-
Jan 2020
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits. * 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 * 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 * Pregnant or nursing women * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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