Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Disease Progression

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

S-1 (40mg) will be given orally twice a day (daily) from Day 1 to 14 (21 day cycle), and Osimertinib (80mg) will be given orally daily continuously.

Oral S-1 + Oral Osimertinib

Darren Wan-Teck Lim, MD

The objective of this study is to determine overall response rate to combination of S-1 and Osimertinib in treatment-resistant EGFR mutant lung cancer.

A lead-in phase of 6 patients will be initiated prior to the formal phase II study. The planned sample size is 27 patients (lead-in and phase II).

The primary objective of the study is to demonstrate that S-1 fixed dose 40 mg BD is safe and effective in EGFR metastatic lung cancer resistant to Osimertinib in terms of best overall response (BOR) The secondary objective of this study will be to further analyse the Disease Control Rate at stipulated timepoints (6,12 and 24 months), Progression-free survival and also the Toxicity by CTCAE 5.0.

A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC

A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC (SOS-1 Study)

The efficacy of S-1 and Osimertinib. ORR is defined as the proportion of subjects who have best objective response (BOR) of CR or PR from start of combination treatment until disease progression or death due to any cause.

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

PFS is defined as time from study entry until objective tumour progression, or death from any cause, whichever occurs first.

Taiho Pharmaceutical Co., Ltd.

National Cancer Centre, Singapore

Dacomitinib

Participants in this cohort have a somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy.

Participants in this cohort have a secondary acquired EGFR mutation in addition to the sensitizing mutation

Cohort 1 Dacomitinib Dosing:

Dose level 1: Dacomitinib 45mg daily Dose level -1: Dacomitinib 30mg daily Dose level -2: Dacomitinib 15mg daily

Cohort 2 Dacomitinib Dosing:

Dose level 1: Dacomitinib 30 mg daily Dose level -1: Dacomitinib 15 mg daily

In cohort 2, participants will begin on dacomitinib orally daily in combination with Osimertinib

Dose level Osimertinib Dosing:

Dose level 1: Osimertinib 80 mg daily Dose level -1: Osimertinib 40 mg daily

Helen Yu, MD

The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Overall response rate (partial and complete responses) of dacomitinib in participants with EGFR-mutant lung cancers and disease progression on osimertinib

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC	NCT05773092	NSCLC	Oral S-1 + Oral...	21 Years - 99 Years	National Cancer Centre, Singapore
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.	NCT03755102	EGFR Gene Mutat... Lung Cancer Lung Cancer Met...	Dacomitinib Osimertinib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for egfr mutant lung cancer