Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Mitogens

Dacomitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dacomitinib+Anlotinib: Patients will be treated with combined Dacomitinib and Anlotinib.

Dacomitinib: Patients will be treated with Dacomitinib.

The dose of each drug in the combination Decomitinib and Anlotinib will be escalated or de-escalated until the recommended phase II dose (RP2D) is reached. Patients will then be treated with RP2D orally once a day.

Dacomitinib+Anlotinib

Dacomitinib orally on a continuous daily basis at a starting dose of 45 mg once a day until progressive disease.

Bo Zhang, MD

Baohui Han, M.D

This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.

This is a multi-center, open-label, Phase I/IIB clinical study of Dacomitinib+Anlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) patients with EGFR 21L858R mutation.

First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

An Open Label, Multicenter, Phase I/IIB Study of Dacomitinib Plus Anlotinib for Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) 21-L858R Mutations.

Overall safety profile of combined Dacomitinib plus Anlotinib in Escalation Phase, including adverse events (AE), as defined and graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE 4.03\], and first cycle Dose Limiting Toxicities (DLTs).

Progression Free Survival (PFS) is defined as the time from start of treatment to the date of disease progression as defined by RECIST v1.1 per investigator review or death due to any cause, whichever occurred first.

Overall Survival is defined as the time from start of treatment to the date of death for any cause. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.

Best overall response is best response from start of treatment until disease progression, and will calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST v1.1, relative to the total number of participants enrolled in the cohort.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations	NCT05271916	Non-Small Cell ...	Dacomitinib+Anl... Dacomitinib	18 Years - 75 Years	Shanghai Chest Hospital
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations	NCT05271916	Non-Small Cell ...	Dacomitinib+Anl... Dacomitinib	18 Years - 75 Years	Shanghai Chest Hospital

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