Lung cancer drug trial pulled before it even started
NCT ID NCT04992858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to test the safety and effectiveness of ningetinib in people with advanced non-small cell lung cancer that has a specific genetic change called MET exon 14 skipping. The trial planned to enroll adults aged 18-75 with stage IIIB-IV cancer. However, the study was withdrawn before any participants were enrolled, so no results are available.
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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.
- Expected to start
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Nov 2022
An estimate. Start dates often move.
- Expected to finish
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Dec 2024
An estimate. End dates often move.
- Lead sponsor
-
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: * Age:18-75 years, male or female. * Histologically or cytologically confirmed IIIB-IV- Advanced NSCLC * There was a Metex 14 skipping mutation in plasma and / or tissue * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 \~2 * Life expectancy of greater than 12 weeks. * Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * Adequate organ function. * Contraception, fertility and not lactating female subjects: screening blood pregnancy test must be negative * Voluntarily join the study and sign informed consent ad has good compliance. Exclusion Criteria: * EGFR or ALK or ROS1 gene mutation was positive * Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;other anti-tumor therapies within 4 weeks, Previously or currently participating in other clinical trials within 4 week, Prior therapies with c-MET targeted drugs; Had received vaccine within 4 weeks prior to study treatment or had a plan to receive vaccine during the trial. * Not recovered from adverse events due to a previously administered agent. * Symptomatic, untreated or unstable central nervous system metastases/ spinal cord compression, cancerous meningitis, or meningitis. * Patients with other malignant tumors except NSCLC within 5 years before the first use of drugs do not include those with negligible risk of metastasis or death (such as expected 5-year OS \> 90%) and expected to be cured after treatment, or any other tumors that have been cured (no evidence of recurrence within 5 years) * There are prescribed cardiovascular and cerebrovascular risk factors * Patients with evidence of bleeding tendency, or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator * History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs. * There are uncontrollable and active infections * Uncontrollable massive pleural / ascites or pericardial effusion * Clinically significant gastrointestinal abnormalities may affect the drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy subjects; * a history of psychotropic drug abuse and can not quit or have mental disorders * Any other reason the investigator considers the patient is not suitable to participate in the study
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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.
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