Olaparib Dose Escalating Trial + Concurrent RT With or Without Cisplatin in Locally Advanced NSCLC

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

May 31, 2019

Study Completion Date

March 13, 2020

Conditions
NSCLC
Interventions
DRUG

Olaparib

"Olaparib will be given orally BID for 36 days, administrated with a 12 hour interval. Olaparib will start 2 days before RT and will continue for 2 days after the last RT fraction. Olaparib is also given during the non-radiotherapy days but no maintenance treatment is given after radiotherapy is finished.~The first cohort will receive Olaparib with a dose of 25mg BID combined with Cisplatin and RT. Thereafter in both with and without cisplatin arms dose escalation will follow to 50mg, 100mg, 200mg, 300mg and 400mg BID."

DRUG

Cisplatin

6 mg/m2 (5 days/week), 1-1.5 hr before the irradiation (week 1 to 5), given as a 5-minutes intravenous infusion.

RADIATION

Radiation

A total dose of 66 Gy will be given in 24 fractions from week 1 to 5, excluding the weekends.

Trial Locations (1)

1066 CX

Netherlands Cancer Institute - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL), Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER