LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor Clinical Trial

— LAT-FLOSI  

Official title:

Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216121
• Other study ID #: S63270
• Status: Recruiting
• Start date: May 10, 2021
• Est. completion date: October 2024

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Patrick Berkovic, MD
• Phone: +32-16-34-51-15
• Email: Patrick.berkovic[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = >3 months).

Description:

The (repeated) use of LAT to ≤ 3 OP lesions with continuation of first-line osimertinib, is endorsed by international guidelines (NCCN, ESMO). In this phase IIb prospective non-randomized observational trial, we want to document the benefit of LAT in this patient cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, = 18 years of age

2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib

3. Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1.

4. Confirmed OPD defined as = 3 intra- and extracranial sites of progressive disease. OP may be defined as progression of an individual metastasis according to RECIST or on 2 consecutive imaging studies at least 2 months apart with a minimum of 5mm increase in size from baseline or an unambiguous development of a new metastatic lesion with a grand total of 3 lesions. All sites must be visible, imaging defined targets, not previously treated with radiation or radiofrequency and suitable for treatment with LAT as determined by the local multi-disciplinary team (MDT).

5. Adequate baseline organ function to allow LAT to all the OP targets.

6. Predicted life expectancy = 6 months

7. Karnofsky Index = 60% and ECOG 0-2

8. Provision of written informed consent

9. Female participants must be surgically sterile or postmenopausal if SBRT is planned to the abdominal area or must agree to use effective contraception during the period of therapy.

Exclusion Criteria:

1. > 3 sites of progressive disease

2. Oligoprogressive metastases not amenable to LAT

3. Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI study

4. Co-morbidities considered clinically precluding the safe use of LAT

5. Any psychological, sociological or geographical issue potentially hampering compliance with the study

6. Pregnancy

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

Intervention

Radiation:
• Local ablative therapy
Stereotactic body radiotherapy

Procedure:
• Local ablative therapy
Surgery

Locations

Country	Name	City	State
Belgium	UZLeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS 2	Progression Free Survival 2	Time from start of osimertinib until first PD after LAT or death whichever comes first, up to 3 year after LAT
Secondary	Time to next line systemic therapy		Time from LAT until initiation of next line systemic therapy or death whichever comes first, up to 3 years after LAT
Secondary	Patterns of disease progression	Patterns of disease progression after local ablative therapy (LAT) identified on sequential CT scans taken at 3 monthly intervals to document the natual history of the disease after LAT	Time from LAT until disease progression or death whichever comes first, up to 3 years after LAT
Secondary	Radiotherapy induced toxicity	Acute and late radiotherapy induced toxicities assessed using the CTCAE v4.0. and the RTOG/EORTC late morbidity score. Acute events are defined as = 90 days post SBRT and late events > 90 days.	Change in toxicity measured from baseline up to 3 years after radiotherapy
Secondary	Quality of life	Quality of life is measured by the EORTC QLQ-LC13 questionnaire comprised both of multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia).	Change in quality of life measured from baseline up to 3 years after radiotherapy