A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
284estimated
Sites
64
Countries
Hong Kong, Italy, Japan +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-10-31 | actual | When the study began enrolling |
| Primary completion | 2025-10-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-07-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non Small Cell Lung Cancer
- EGFR Exon 20 Mutation
Intervention
- Drug: CLN-081 — also filed as TAS6417; zipalertinib
Primary outcomes
what the primary-completion date above is the date OFAll Cohorts: The rate and severity of treatment emergent AEs.
measured 24 months
All Cohorts: The rate and severity of DLTs.
measured 24 months
Phase 2 Dose Expansion Cohorts: Overall response rate (ORR)
measured 24 months
Module A: Pharmacokinetic (PK) parameter
measured 24 months
Module A: Pharmacokinetic (PK) parameter
measured 24 months
Module B and C: Confirmed overall response rate (ORR) and duration of response (DOR) by independent review committee (IRC)
measured 24 months
Publications
- PMID 40450572 — linked by the registry
- PMID 37384848 — linked by the registry
- PMID 33122578 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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