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NCT07045610
Primary Resistance Mechanisms of ALK TKIs
trial testing re-biopsy tumor with primary ALK tKI resistance for NGS in ALK-positive Advanced NSCLC Patients in 20 participants. Not yet recruiting.
1 July 2027
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 July 2025 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 July 2028 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- re-biopsy tumor with primary ALK tKI resistance for NGS
Conditions studied
- ALK-positive Advanced NSCLC Patients — all drugs for ALK-positive Advanced NSCLC Patients →
- Primary Resistance — all drugs for Primary Resistance →
- NGS — all drugs for NGS →
Sponsor
National Taiwan University Hospital
Who can join
18 and older, any sex, with ALK-positive Advanced NSCLC Patients or Primary Resistance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anaplastic lymphoma kinase (ALK) gene rearrangement is a known oncogenic driver in non-small cell lung cancer (NSCLC). ALK tyrosine kinase inhibitors (TKIs) have been clearly shown to produce excellent therapeutic effects and prolong survival in patients with this gene mutation. According to current treatment guidelines, ALK inhibitors are the first-line treatment of choice for ALK-positive advanced NSCLC patients. However, although ALK TKIs are very effective, there is still a small group of patients who do not achieve good treatment outcomes, developing resistance and tumor progression within 3 to 6 months of initial ALK TKI use. This is called primary resistance. Intrinsic resistance to ALK inhibition occurs when the best clinical response after first-generation and second/third-generation TKI treatment is disease progression. Approximately 5-7% of cases after crizotinib treatment, 9% after ceritinib treatment, and 25% after lorlatinib treatment show no response to treatment, and no specific ALK mutation has been found to explain the occurrence of primary resistance. Currently, many different resistance mechanisms are known, some of which are still ALK-related, while others are ALK-independent alternative survival pathways. However, most research focuses on acquired resistance, with very few studies on primary resistance, only a few case reports. Therefore, this study aims to explore the primary ALK TKI resistance mechanisms. The investigators plan to explore the incidence and mechanisms of primary ALK TKI resistance in ALK-positive advanced NSCLC patients who develop primary resistance or rapid progression (within 3-6 months) during ALK inhibitor treatment by re-obtaining tumor samples for genetic analysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07045610
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07045610 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 1 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07045610.
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