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NCT04969965
To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations
Phase 1 trial testing aumolertinib in NSCLC in 45 participants. Completed in 7 October 2021.
7 October 2021
Quick facts
| Lead sponsor | EQRx, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 21 June 2021 |
| Primary completion | 7 October 2021 |
| Estimated completion | 7 October 2021 |
| Sites | 2 locations across New Zealand, United States |
Drugs / interventions tested
- aumolertinib — full drug profile →
Conditions studied
- NSCLC — all drugs for NSCLC →
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
EQRx, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with NSCLC or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label and uncontrolled study to evaluate the comparative PK of EQ143 following oral single dose administration in adult healthy volunteers different racial and ethnic populations. A total of one (1) single dose cohort is planned at 110 mg of EQ143. EQ143 is an approved therapy in China at the 110 mg dose for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) T790Mmutation-positive, metastatic non-small cell lung cancer (NSCLC), who have progressed during or after EGFR tyrosine kinase inhibitor (TKI) therapy. A total of 45 (15 Caucasian, 8 Black/African American and 7 Hispanic/Latino, and 15 ethnic Chinese)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04969965
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of aumolertinib
Trials testing the same drug.
- NCT05199610 — An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143 · Phase 1 · completed
Other recruiting trials for NSCLC
Currently open trials in the same condition.
- NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
- NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07325864 — Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site · recruiting
- NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting
Other EQRx, Inc. trials
Trials by the same sponsor.
- NCT05085002 — A Study of Lerociclib in Participants With Advanced Breast Cancer · Phase 2 · terminated
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 NCT04969965 (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 EQRx, Inc.
- Last refreshed: 28 June 2022
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/NCT04969965.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing