VALT28/ PRL01: Durvalumab and low-dose Prophylactic Cranial Irradiation (PCI) versus durvalumab and observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study

Phase 3

Recruiting

Conditions: Stage III non-small cell lung cancer (NSCLC)
10029107

Registration Number: NL-OMON54172

Lead Sponsor: ederlandse Vereniging van artsen voor Longziekten en Tuberculose

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 170

Inclusion Criteria

Stage III non-small cell lung cancer without distant metastases as proven by
imaging.
Treatment completed with concurrent chemoradiation, within 52 days before start
of durvalumab.
Eligible for durvalumab treatment in standard of care setting.
ECOG perfomance statust 0-1.
Signed and dated informed consent.

Exclusion Criteria

Prior cranial irradiation is not allowed.
Any unresolved toxicity CTCAE vs 5.0 more than grade 2 from the prior
chemoradiation therapy.
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for
cancer treatment.
Any condition that, in the opinion of the investigator, would interfere with
evaluation of the study drug or interpretation of patient safety or study
results.
Non-pregnant, non lactating.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Cumulative incidence of brain metastases 24 months after the last patient has<br /><br>been randomized. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time to 5 points or more decline in the HVLT-R total recall compared to<br /><br>baseline (first: 4 months compared to baseline, additional: every year compared<br /><br>to baseline).<br /><br>- Time to develop neurological symptoms (confirmed or unconfirmed by imaging)<br /><br>- Side effects: decline in ECOG performance status and CTCAE v. 5.0<br /><br>(neurological/fatigue) as well as Pro-CTCAE<br /><br>- Patient reported neurocognitive memory decline<br /><br>- QoL: QLQ-C30, and EuroQol 5D<br /><br>- Overall survival<br /><br>- Quality adjusted survival (QALYs)<br /><br>- Health care costs<br /><br>-Effect of durvalumab on cardiac function</p><br>