NCT06620835: OPTALK

Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib

Recruiting now Phase 2 Last updated 29 July 2025

What this trial tests

Phase 2 trial testing Blood samples for Hematology in NSCLC in 45 participants. Currently enrolling.

Timeline

19 June 2025

Primary endpoint
1 October 2030

1 October 2030

Quick facts

Lead sponsor	Groupe Francais De Pneumo-Cancerologie
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	19 June 2025
Primary completion	1 October 2030
Estimated completion	1 October 2030
Sites	27 locations across France

Drugs / interventions tested

• Blood samples for Hematology — full drug profile →
• Blood samples for Chemistry — full drug profile →
• Blood sample for liver function tests — full drug profile →
• Pregnancy test — full drug profile →
• Tumour assessment
• Local Ablative Therapy (LAT)

Conditions studied

• NSCLC — all drugs for NSCLC →

Sponsor

Groupe Francais De Pneumo-Cancerologie — full company profile →

Who can join

18 and older, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered when the brigatinib works best in participants presenting an advanced non-small cells lung cancer with an ALK gene anomaly (this anomaly produces a defective protein that is responsible for the multiplication of cancer cells).

This clinical trial is expected to involve 45 participants in several sites in France.

Advanced non-small cell lung cancer (NSCLC) participants with ALK rearrangements treated with brigatinib in first line of non-curable setting will be screened.

If the disease assessment done between 3 to 9 months after initiation of brigatinib shows:

* a tumor response or stabilization (according to RECIST 1.1)
* a disease which meets the definition of an oligometastatic disease (five metastatic lesions or less and a maximum of two lesions per organ)
* all tumor targets are accessible to a local ablative therapy (confirmed by an expert panel of clinicians before inclusion): surgery, stereotactic radiosurgery (SRS). For liver, adrenal, or other metastases, percutaneous thermal ablation will be accepted.

Participants will be asked to visit the clinic:

* for eligibility criteria assessment prior to LAT
* for LAT
* every 8 weeks for checkups and tests the first year after LAT
* and then every 12 weeks, for a maximum period of 3 years.

Eligible patients will benefit from local ablative therapy with continuation of brigatinib.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Insights on Oligometastatic Non-Small-Cell Lung Cancer.
   Valdivia A, Mascaro-Baselga P, Salva-de Torres C, Geng-Cahuayme A, et al · · 2025 · PMID 40805152 · DOI 10.3390/cancers17152451