Trial Evaluating Maintenance Olaparib in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer
Status:
Unknown status
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
This is a multicentre randomised double-blind phase II trial, sponsored by Gustave Roussy and
involving one French center as well as the Spanish Lung Cancer Group (≈20 centers of the
SLCG).
Six hundred patients with diagnosis of stage IIIB/IV NSCLC will initially be registered prior
to receiving the first line platinum-based chemotherapy or during or at the end of the first
6 cycles of inducation platinium based chemotherapy and provide consent for retrieving
archival tissue collection and providing translational blood samples and tumor biopsies.
1. - Induction chemotherapy phase All patients will initially be treated with 6 cycles of
platinum-based induction chemotherapy. Cycle duration will be 21 days. Doublets should
either consist of a pemetrexed-platinum (cisplatin or carboplatin) doublet
(preferentially for non-squamous NSCLC) or a gemcitabine - or vinorelbine - platinum
doublet for squamous NSCLC. Taxanes-platinum doublets will not be accepted.
Translational blood samples will be taken at the beginning of induction chemotherapy for
all patients.
Patients displaying progressive disease or stable disease after induction chemotherapy
will be withdrawn and further optimally managed according to local practice. For them,
an optional tumour biopsy will be performed at the end of the induction treatment.
2. - Randomisation and maintenance phase Only patients who respond to platinum-based
induction chemotherapy will be further randomised between olaparib and placebo. These
patients must have been treated with 6 cycles of chemotherapy. However, patients who
haven't received 6 cycles of the induction chemotherapy due to severe toxicity (grade 3
or 4, NCI CTCAE v4.0) could be randomized only if they had received 4 chemotherapy
cycles at least and if all treatment related toxicities are resolved to a grade ≤ 1 (NCI
CTCAE v4.0).
Treatment will be administered at a dose of 600 mg daily (2 doses of 300 mg [2 tablets of 150
mg] taken approximately 12 hours apart) and cycle duration will be 28 days. Disease will be
assessed every 2 cycles by CTscan (MRI or PET-scan if the scan is not contributive) and
treatment will be administered until disease progression or unacceptable toxicity. Patients
will then be optimally managed according to local practice. Follow-up will be for a minimum
of 15 months from the time of randomization, and until last venue. All randomised patients
will be asked to provide translational blood samples at randomization, on treatment and at
the end of the treatment. Optional tumour biopsies will be performed at randomization, at the
end of the treatment (or at disease progression if available).