CLINICAL TRIALS PROFILE FOR AUMOLERTINIB

Clinical Trials for Aumolertinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04922138 ↗	Aumolertinib in Treatment of Resectable Stage IA EGFRm+ NSCLC: a Multi-center, Single-arm Clinical Trial	Not yet recruiting	Jiangsu Hansoh Pharmaceutical Co., Ltd.	Phase 2	Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
NCT04922138 ↗	Aumolertinib in Treatment of Resectable Stage IA EGFRm+ NSCLC: a Multi-center, Single-arm Clinical Trial	Not yet recruiting	Baohui Han	Phase 2	Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
NCT04923906 ↗	Aumolertinib With or Without Chemotherapy as 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations	Not yet recruiting	Jiangsu Hansoh Pharmaceutical Co., Ltd.	Phase 3	To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
NCT04969965 ↗	To Evaluate the Comparative Pharmacokinetics of Orally Administered EQ143 in Different Racial and Ethnic Populations	Completed	EQRx, Inc.	Phase 1	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)
NCT05199610 ↗	An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of EQ143	Not yet recruiting	EQRx, Inc.	Phase 1	Participants aged 18 to 75 years with severe hepatic impairment (Child-Pugh class C) who meet the full study eligibility criteria will be enrolled into the study. For each participant with severe hepatic impairment, a corresponding healthy participant will be enrolled who matches with regard to age, sex, BMI, and, if possible, smoking habit. A single dose of 55-mg EQ143 tablet will be administered in the morning on Day 1, and participants will remain for 5 days (4 nights) in the study center for collection of blood samples and safety monitoring. Participants will attend outpatient follow-up visits on Days 5, 6, 8, and 9 for additional blood sampling and safety assessments. The study will measure and describe the concentrations of EQ143 and its metabolite (HAS-719) in blood plasma over the course of 9 days (including calculation of PK parameters), the degree of EQ143 binding to plasma proteins in blood, and the safety of administering a single dose of EQ143 in severely hepatically impaired and matched healthy participants.
NCT05338970 ↗	A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy	Recruiting	Daiichi Sankyo, Inc.	Phase 3	Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.
NCT05493501 ↗	Aumolertinib Alone and With Chemotherapy in Patients With EGFR-Mutant Non-Small Cell Lung Cancer	Not yet recruiting	EQRx International, Inc.	Phase 3	The purpose of this study is to evaluate the efficacy and safety of aumolertinib and chemotherapy versus aumolertinib alone, along with an osimertinib reference arm, in systemic treatment-naïve participants who have metastatic EGFR-mutant NSCLC and an ECOG PS of 0, 1, or 2. Additional study details include the following: - The study duration will be approximately 5 years. - Participants can continue to receive treatment as long as they are judged by the Investigator to continue to receive clinical benefit in the absence of meeting the discontinuation criteria

Clinical Trial Conditions for Aumolertinib

Condition Name

Condition Name
Intervention	Trials
Non-small Cell Lung Cancer	4
Lung Cancer	3
NSCLC	3
Pharmacokinetics	1

Condition MeSH

Condition MeSH
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	8
Lung Neoplasms	6
Neoplasm Metastasis	1
Liver Diseases	1

Clinical Trial Locations for Aumolertinib

Trials by Country

Trials by Country
Location	Trials
United States	11
China	10
Italy	1
Netherlands	1
Singapore	1

Trials by US State

Trials by US State
Location	Trials
Wisconsin	2
Virginia	1
Texas	1
Tennessee	1
Oregon	1

Clinical Trial Progress for Aumolertinib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	4
PHASE1	2

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	7
Not yet recruiting	5
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for Aumolertinib

Sponsor Name

Sponsor Name
Sponsor	Trials
Jiangsu Hansoh Pharmaceutical Co., Ltd.	4
EQRx, Inc.	2
Shanghai Pulmonary Hospital, Shanghai, China	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	10
Other	9