Increasing the dosing interval of osimertinib in patients with EGFR mutated locally advanced or meta-static non-small cell lung cancer - OSI-SAVE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-06-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The assessment of the non-inferiority of an extended dosing interval of osimertinib compared to the standard dosage.

Secondary objectives 6

1. To assess the efficacy of osimertinib 80 mg QOD compared with osimertinib 80 mg QD.
2. To assess the safety of osimertinib 80 mg QOD compared with osimertinib 80 mg QD.
3. To assess disease-related symptoms and health-related quality of life in patients treated with osimertinib 80 mg QOD compared to osimertinib 80 mg QD.
4. To assess cost-effectiveness for patients treated with osimertinib 80 mg QOD compared with osimertinib 80 mg QD.
5. To evaluate the effect of osimertinib 80 mg QOD compared with osimertinib 80 mg QD on the risk of developing central nervous system (CNS) metastases over time.
6. To assess the feasibility and patient adherence to osimertinib 80 mg QOD compared with osimertinib 80 mg QD.

Conditions and MedDRA coding

EGFR mutated locally advanced or metastatic non-small cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥18 years
2. Able to understand the written information and able to give informed consent
3. Sufficient knowledge of the local language in order answer the questionnaires
4. Locally advanced or metastatic NSCLC with an EGFR exon 19 deletions or exon 21 L858R muta-tions not eligible for curative intent therapy
5. Treatment with first-line osimertinib 80 mg QD with or without chemotherapy for at least three months according to standard of care;
6. A response on radiologic assessment (response is defined as: - complete or partial response as defined by RECIST 1.1, assessed by the treating physi-cian. - a radiological response according to the treating physician that does not meet the crite-ria for partial response according to RECIST 1.1.)

Exclusion criteria 4

1. Patients with known CNS metastases at baseline
2. Usage of strong CYP3A4 inducers as described in 9.1.2
3. Treatment related toxicity for which a dose reduction of osimertinib is indicated
4. Patients who are either pregnant, breastfeeding or actively trying to conceive

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS)

Secondary endpoints 6

1. Overall survival (OS)
2. Patient reported toxicity of any grade (laboratory abnormalities excluded)
3. Economic assessment
4. Quality of life
5. Cumulative incidence of central nervous system (CNS) metastases
6. Feasibility / medication adherence

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Prof. dr. A.C. Dingemans

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Drs. M. van den Bos

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications