Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Disease Progression

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.

EGFR tyrosine kinase inhibitor

EGFR tyrosine kinase inhibitor with chemotherapy

Qiong Zhao, PhD

There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.

We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.

Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

Phase II Study of Continuation of Tyrosine Kinase Inhibitor (TKI) With or Without Chemotherapy Beyond Gradual Progression in Advanced Non-small Cell Lung Cancer (NSCLC)

Zhejiang University

Chief of Department of Thoracic Oncology

Antineoplastic Agents

Mitogens

Naquotinib

Single oral administration of ASP8273 Capsule A for bioavailability evaluation, followed once daily multiple administration of ASP8273 Capsule

ASP8273 Capsules

ASP8273 Capsules A

Medical Director

The purpose of this study is to determine the safety, the antitumor activity and the pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.

This study consists of a single-dose period (Cycle 0 lasting 3 days) and a multiple-dose period (from Cycle 1 onwards, each cycle lasting 21 days). To compare the PK between ASP8273 Capsules and ASP8273 Capsules A, enrolled subjects will receive a single oral dose of ASP8273 Capsules A on Day 1 of Cycle 0 in the single-dose period and will then be observed for 3 days (including the day of dosing). In the multiple-dose period, subjects will receive multiple oral doses of ASP8273 Capsules during each cycle lasting 21 days. From the viewpoint of PK comparison (bioavailability \[BA\] evaluation) between ASP8273 Capsules and ASP8273 Capsules A, data from approximately 15 subjects are sufficient for the evaluation. Therefore, if PK data of approximately 15 subjects included in BA evaluation are obtained and the sponsor judges that further acquisition of PK data is not necessary, the single-dose period will not be conducted in subjects who are enrolled thereafter (subjects not included in BA evaluation). Subjects will continue to receive treatment with ASP8273 until they meet the discontinuation criteria.

A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR Mutations

Phase II Study of ASP8273 - An Open-Label, Study of the Oral Administration of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-NaïvePatients With Non-Small Cell Lung Cancer Harboring EGFR Mutations

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

The overall response rate is defined as the proportion of subjects whose best overall response is rated as Complete response (CR) or Partial Response (PR)among all analyzed subjects

The disease control rate is defined as the proportion of subjects whose best overall response is rated as Complete response (CR), Partial Response (PR), or Stable disease (SD) among all analyzed subjects

Astellas Pharma Inc

Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects

icotinib

Kaican Cai, MD

Siyang Feng, MM

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression	NCT01998061	Non Small Cell ...	EGFR tyrosine k... EGFR tyrosine k...	18 Years - 75 Years	Zhejiang University
A Study of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-Naïve Patients With Non-Small Cell Lung Cancer Harboring EGFR Mutations	NCT02500927	EGFR-TKI-naïve ...	ASP8273 Capsule... ASP8273 Capsule...	20 Years -	Astellas Pharma Inc
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer	NCT02272127	NSCLC	icotinib	18 Years -	Nanfang Hospital, Southern Medical University
Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression	NCT01998061	Non Small Cell ...	EGFR tyrosine k... EGFR tyrosine k...	18 Years - 75 Years	Zhejiang University

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