Trial Evaluating Maintenance Olaparib in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer (PIPSeN)
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|ClinicalTrials.gov Identifier: NCT02679963|
Recruitment Status : Unknown
Verified July 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : February 11, 2016
Last Update Posted : August 1, 2017
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.
- 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Patients displaying progressive disease or stable disease after induction chemotherapy will be withdrawn and further optimally managed according to local practice.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.
- - 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).
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Olaparib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double-blind Phase II Trial Evaluating Maintenance Olaparib Versus Placebo in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Maintenance Olaparib
Olaparib (experimental arm): 600 mg daily (2 doses of 300 mg (2*2 tablets of 150 mg) taken approximately 12 hours apart) po, administered until disease progression or toxicity requiring its interruption. Olaparib has to be started no later than 6 weeks after the last administration of induction chemotherapy, and no later than 3 weeks after the CT scan confirming response to induction chemotherapy
Placebo Comparator: Placebo
Placebo (control arm): 2 doses of 300 mg per day (2*2 tablets of 150 mg) taken approximately 12 hours apart
- Progression Free Survival [ Time Frame: Assessed every 56 days up to 15 months ]By CT scan, MRI or TEP-scan according to RECIST 1.1 criteria
- Overall Survival [ Time Frame: Measured from patient randomization to death or last follow-up for patient alive or consent withdrawal up to 15 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679963
|Contact: Sophie Postel-Vinay, MD||0142114343 ext +email@example.com|
|Contact: Valérie Mairot||0142113730||Valerie.firstname.lastname@example.org|
|Gustave Roussy Cancer Campus||Recruiting|
|Villejuif, Val de Marne, France, 94805|
|Contact: Valérie Mairot 0142113730 ext +33 Valerie.email@example.com|