Clinical trial · Interventional
A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
NCT04398940CI-TRIAL-00047099unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3139 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3139 capsules
- description
- TQ-B3139 capsules administered orally.
- interventionNames
- Drug: TQ-B3139
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 18 months
- description
- Percentage of subjects achieving complete response (CR) and partial response (PR).
Secondary outcomes (7)
- measure
- Progression-free survival (PFS)
- timeFrame
- up to 18 months
- description
- PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form. Exclusion Criteria: * 1\. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval \> 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.