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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

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Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pemetrexed

Cisplatin

Mitogens

Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib daily with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.

Dose may be reduced to allow for the management of investigational drug related toxicity.

Aumolertinib

Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.

Placebo Aumolertinib

Shun Lu, MD

Zhonglin Chen, MD

Shun Lu

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+).

HS-10296-306 is a randomized, open-label, multicenter, phase III study 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+). Eligible patients are randomized to receive either Aumolertinib (110 mg orally, once daily) in combination with platinum-based chemotherapy (every 3 weeks for 4\~6 cycles) or Aumolertinib (110 mg orally, once daily) in a 1:1 ratio.

Aumolertinib With or Without Chemotherapy as 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations

Efficacy and Safety of Aumolertinib With or Without Chemotherapy as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing Epidermal Growth Factor Receptor Mutations: A Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study

IRC-PFS is defined as the time from randomization until the date of objective disease progression based on IRC assessment or death (by any cause in the absence of progression). The patients will receive long-term follow-up including chest and abdominal CT every 6 weeks until Week 18, then every 12 weeks and onwards.

ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.

DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD.

DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions.

PFS Rate at 12, 18, 24, and 36 months is defined as proportion of progression free survival at 12, 18, 24, and 36 months from the date of randomization.

Overall survival (OS) is deﬁned as the time from randomization to death due to any cause. The survival will be followed up with telephone every 12 weeks after discontinuation of the randomized treatment.

OS rate at 3, 5 years is defined as the proportion of patients alive at 3, 5 years from the date of randomization.

AEs are graded according to CTCAE v5.0 and recorded in the case report form.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

single arm,Treatment plan: Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.

Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.

Aumolertinib,Anlotinib

Zhan sheng Jiang, Doctor

Zhan Yu Pan, Doctor

The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.

The primary objective of this study was to explore the median PFS of aumolertinib Combined With anlotinib as first-line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation.The secondary objective of this study was to evaluate the ORR, DCR, DOR, OS and safety of aumolertinib Combined With anlotinib as first-line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. In addition, we also try to explore predictive or prognostic biomarkers (tissue and/or plasma) related to disease treatment response or drug resistance. Analyze the potential biomarkers in the biopsy tissue samples and blood samples after the disease progresses, and explore the possible mechanism of treating drug resistance.

Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

The rate of participants that achieve either a complete response (CR) or a partial response (PR).

The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.

The time of death from all causes for all patients from the date of randomization.

AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.

Tianjin Medical University Cancer Institute and Hospital

Aumolertinib 110 mg once daily (110 mg per day) orally for 36 months.

Aumolertinib 110 mg per day orally for 3 years.

Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).

A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.

3-year DFS was defined as the proportion of patients who were disease free at 3 years.

Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Number of participants with perioperative complications

3-year OS was defined as the proportion of patients who were alive at 3 years.

Sun Yat-sen University

Professor

Antibodies

Antibodies, Bispecific

Immunoglobulins

Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily.

Participants will receive Aumolertinib 110 mg orally once daily.

Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)

HS-20117

Jialei Fu

Dingzhi Huang, M.D.

Yun Fan, M.D.

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

This is a multicenter Phase Ib/III clinical study evaluating the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20117 in combination with aumolertinib in subjects with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The study is divided into two phases, Phase Ib, a dose expansion study and Phase III, a confirmatory study. In the dose expansion phase (Phase Ib), HS-20117 will first be studied in combination with the standard dose of aumolertinib, to assess the efficacy, safety, tolerability, PK profile, and immunogenicity of HS-20117 in combination with aumolertinib in the target population, as well as to determine the recommended Phase III dose (RP3D). Following confirmation of the safety and efficacy of HS-20117 in combination with aumolertinib and RP3D in Phase Ib, a randomized, active-controlled, open-label, multicenter Phase III study will be initiated to assess the efficacy and safety of HS-20117 in combination with aumolertinib versus aumolertinib in the target population in the confirmatory study phase.

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

ORR is defined as the percentage of participants with DOR of confirmed CR or confirmed PR per RECIST v1.1

PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1

Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

DCR is deﬁned as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) based on Investigator's assessment per RECIST v1.1.

DoR only applies to participants whose best overall response is CR or PR based on Investigator's assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1

DCR is deﬁned as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks)

DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Immunogenicity will be measured by the number of participants that are ADA positive.

The Cmax is the maximum observed serum concentration of HS-20117

Ctrough is the observed serum concentration immediately prior to the next administration

The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period(tau)

The Tmax is defined as time to reach maximum observed serum concentration of HS-20117

The t1/2 is defined as the time it takes for the concentration levels to fall to 50% of their value.

Hansoh BioMedical R&D Company

Aumolertinib treatment (110mg, p.o., QD) for 8 weeks

Wenhua Liang, M.D

Jianxing He, M.D

This is a prospective, single-center, single-arm, phase II study evaluating the efficacy and safety of neoadjuvant aumolertinib in previously untreated patients with AI-diagnosed EGFR-mutant and resectable pulmonary ground-glass opacity.

After informed consent signed, enrolled patients will undergo a treatment period and a follow-up period. During the treatment period, patients will receive aumolertinib treatment (110mg, p.o., QD) for 8 weeks. The surgery can be performed after a 1 to 2-week discontinuation period; if the patient does not consent to undergo surgery, follow-up can be conducted instead. If patients experience disease progression during the treatment period, they will be withdrawn from the study. During the follow-up period, the investigator will provide appropriate treatment recommendations based on the patient's condition and pathological results after surgical resection of the target lesion. Postoperative patients (or patients who completed the medication treatment and were followed up) will be monitored every six months for a duration of one year.

Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.

Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity: A Single-arm, Phase II Trial

This analysis observes the changes in the EGFR mutation prediction value of the target lesion diagnosed by AI before and after receiving neoadjuvant treatment with Aumolertinib.

ORR (Objective Response Rate) is defined as the proportion of participants who confirmed at least one CR (Complete Response) or PR (Partial response) before disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator.

pCR (Pathological Complete Response) is defined as the proportion of patients in whom no tumor cells are found in all pathological samples after surgical resection following neoadjuvant treatment.

MPR (Major Pathological Response) is defined as the presence of residual tumor of less than 10% on pathological assessment after neoadjuvant treatment-induced tumor regression.

PFS (Progression-Free Survival) is defined as the time from the first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression.

OS (Overall Survival) is defined as the time from the initial administration of treatment to the date of death due to any cause. Patients who have not died at the time of statistical analysis will have their survival time censored at the last known date of their survival.

The First Affiliated Hospital of Guangzhou Medical University

Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day .

All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.

Baohui Han, doctor

Baohui Han, M.D

Chang Chen, M.D

Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.

This is a multi-center, two-arm clinical study. In patients with stage I non-squamous non-small cell lung cancer (NSCLC) with EGFR 19del/21L858R with solid, micropapillary, and/or complex gland components ≥10% who have not received any systemic treatment, to evaluate the efficacy and safety of postoperative adjuvant Aumolertinib in NSCLC patients .

Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns

Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I NSCLC With High-grade Patterns and EGFR-sensitizing Mutations (APPOINT)

Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis

Defined as the proportion of patients alive and disease free at 3, 4 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.

Defined as the time from the date of treatment start until date of death due to any cause

Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aumolertinib With or Without Chemotherapy as 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations	NCT04923906	Non-small Cell ...	Aumolertinib Placebo Aumoler...	18 Years -	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation	NCT05778149	Aumolertinib Anlotinib TP53 NSCLC EGFR Activating...	Aumolertinib,An...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation	NCT05778149	Aumolertinib Anlotinib TP53 NSCLC EGFR Activating...	Aumolertinib,An...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).	NCT06227897	Lung Cancer	Aumolertinib	18 Years - 75 Years	Sun Yat-sen University
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer	NCT06417008	Non-Squamous No...	HS-20117 Aumolertinib	18 Years - 75 Years	Hansoh BioMedical R&D Company
Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.	NCT05946460	Lung Cancer	Aumolertinib	18 Years - 75 Years	The First Affiliated Hospital of Guangzhou Medical University
Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns	NCT04922138	Lung Cancer	Aumolertinib	18 Years -	Shanghai Chest Hospital

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