Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

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Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy

Patients with EGFR Exon20ins, treatment naïve

Sunvozertinib

Pasi Antero Jänne, M.D & Ph. D

This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of Sunvozertinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation. This study includes dose escalation, dose expansion, food effect (Part A) and dose extension (Part B).

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

To investigate the safety and tolerability of Sunvozertinib when given orally to patients with advanced NSCLC with EGFR or HER2 mutations; To establish Maximum Tolerated Dose (MTD) (if possible) and Recommended Phase 2 Dose (PR2D) of Sunvozertinib when given orally in patients with advanced NSCLC with EGFR or HER2 mutations.

To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).

To characterize the pharmacokinetics (PK) of Sunvozertinib following a single oral dosing and at steady state after multiple oral dosing in the fasted state, and renal excretion of Sunvozertinib.

To evaluate the effect of food on the exposure of Sunvozertinib at the defined doses.

To assess preliminary anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator.

To retrospectively assess anti-tumor activity of Sunvozertinib in patients with EGFR Exon20ins according to RECIST 1.1 by an Independent Review Committee (IRC).

To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.

To determine the safety and tolerability of Sunvozertinib.

Dizal Pharmaceuticals

Symptoms and General Pathology

Neoplasm Metastasis

Antineoplastic Agents

All Drugs and Chemicals

Pemetrexed

Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)

Chemotherapy

Li Li, BA

Feifei Na, MD

You Lu, MD

To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.

Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II

Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)

To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death

To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause

To assess overall survival, define as first dose to the death of the subject due to any cause

Number of participants with adverse events (AEs) according to CTCAE 5.0

Sichuan University

Chair of Department of Thoracic Oncology

Immune System Diseases

Hypersensitivity

A Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib plus Anlotinib in EGFR-Sensitive Mutations Combined with Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sunvozertinib 300 mg once daily (QD) with Anlotinib 8mg once daily （QD in Day 1-14），21 days in one cycle.

sunvozertinib in combination with Anlotinib

Yongchang Zhang

Liang Zeng

This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.

This is a Phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with locally advanced or metastatic primary non-small cell lung cancer with EGFR-sensitive mutations combined with co-mutations. Approximately 52 NSCLC patients with EGFR-sensitive mutations (19del, L858R and T790M) and co-mutations were enrolled and treated with sunvozertinib (300 mg once daily) in combination with anlotinib (8 mg once daily for 2 weeks, followed by a 1-week interruption) until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was investigator-assessed PFS, and secondary endpoints included ORR, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about April 2024. It is expected that the trial will end in Dec 2027.

Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW

A Perspective Observation Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic NSCLC

Hunan Province Tumor Hospital

Professor

Drug: Sunvozertinib combination with Anlotinib

Sunvozertinib 300 mg once daily (QD) with Anlotinib 8mg once daily （QD in Day 1-14），21 days in one cycle.

This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.

Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2

This is a Phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with locally advanced or metastatic primary non-small cell lung cancer with EGFR-sensitive mutations combined with co-mutations. Approximately 52 NSCLC patients with EGFR-sensitive mutations (19del, L858R and T790M) and co-mutations were enrolled and treated with sunvozertinib (300 mg once daily) in combination with anlotinib (8 mg once daily for 2 weeks, followed by a 1-week interruption) until the patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint was investigator-assessed PFS, and secondary endpoints included ORR, DCR, OS, and safety. The study is expected to commence recruitment in mainland China in about April 2024. It is expected that the trial will end in April 2027.

Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC

A Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (WUKONG-32)

To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)	NCT03974022	Non-Small Cell ...	Sunvozertinib	18 Years -	Dizal Pharmaceuticals
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II	NCT06195189	Non Small Cell ...	Sunvozertinib Chemotherapy	18 Years - 80 Years	Sichuan University
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II	NCT06195189	Non Small Cell ...	Sunvozertinib Chemotherapy	18 Years - 80 Years	Sichuan University
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)	NCT03974022	Non-Small Cell ...	Sunvozertinib	18 Years -	Dizal Pharmaceuticals
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW	NCT06355609	Non-small Cell ...	sunvozertinib i...	18 Years -	Hunan Province Tumor Hospital
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)	NCT03974022	Non-Small Cell ...	Sunvozertinib	18 Years -	Dizal Pharmaceuticals
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC	NCT06348927	Non-Small Cell ...	sunvozertinib i...	18 Years -	Hunan Province Tumor Hospital

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