NSCLC Clinical Trial
Official title:
Olaparib Dose Escalating Trial in Patients Treated With Radiotherapy With or Without Daily Dose Cisplatin for Locally Advanced Non-small Cell Lung Carcinoma
Phase I dose escalating trial. Primary objective of this study is to define the maximal tolerated dose (MTD)of Olaparib in combination with high dose radiotherapy with or without daily dose Cisplatin in locally advanced NSCLC. Secondary objectives include to define safety profile, determine PK/Pd variables and document preliminary evidence of objective tumor response.
Concurrent chemoradiotherapy (CCRT) is the treatment of choice for patients with locally
advanced NSCLC. The cure rates however need to be improved. The main mechanism by which both
radiation and Cisplatin kill tumor cells is by an accumulation of un- or misrepaired DNA
damage.PARP inhibitors increase radiation and chemotherapy (Cisplatin) response in
preclinical studies including lung cancer models.
This open label dose escalating trial consists of a screening phase, a treatment phase and a
follow up phase.
The screening phase: patients who can tolerate concurrent cisplatin will receive Olaparib, RT
and Cisplatin. Patients who can not tolerate concurrent cisplatin will receive Olaparib and
RT with or without prior sequential chemotherapy.
The treatment phase:dose escalation of Olaparib will be performed in cohorts of 3 subjects.
The decision to escalate to the next dose level will be based on the occurrence of DLTs
during the DLT evaluation period (i.e. 3 months following the last day of irradiation) and
will be made after all patients within the cohort have completed their third month of follow
up.
Active follow-up phase: frequent follow up will take place during the first 3 months (acute
toxicity). Thereafter patients will be monitored for late toxicity and for disease activity
3-monthly throughout the first year and thereafter 6-monthly until 5 years, when patients are
deemed to be cured and follow up is no longer warranted.
Olaparib will be given orally BID for 36 consecutive days, administrated with a 12 hour
interval. Olaparib will start 2 days before start of 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.
Radiotherapy (for all patients): a total dose of 66Gy will be given in 24 fractions from week
1 to 5.
Cisplatin (concurrent chemoradiotherapy): daily dose Cisplatin 6mg/m2 (5 days/week), 1-1.5 hr
before the irradiation (week 1 to 5), given as a 5-minutes intravenous infusion.
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