NCT02679963

Brief 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. 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.
  2. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

January 26, 2016

Last Update Submit

July 31, 2017

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    By CT scan, MRI or TEP-scan according to RECIST 1.1 criteria

    Assessed every 56 days up to 15 months

Secondary Outcomes (1)

  • Overall Survival

    Measured from patient randomization to death or last follow-up for patient alive or consent withdrawal up to 15 months

Study Arms (2)

Maintenance Olaparib

EXPERIMENTAL

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

Drug: Olaparib

Placebo

PLACEBO COMPARATOR

Placebo (control arm): 2 doses of 300 mg per day (2\*2 tablets of 150 mg) taken approximately 12 hours apart

Drug: Placebo

Interventions

OlaparibDRUG
Maintenance Olaparib
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have normal organ and bone marrow function measured within 14 days prior to administration of the platinum based treatment
  • Haemoglobin ≥ 10.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
  • Creatinine clearance \> 60mL/min as calculated by Cockroft-Gault formula for cisplatin administration; creatinine clearance \>/= 51mL/min by Cockroft-Gault formula for carboplatin administration
  • Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment.
  • Postmenopausal is defined as:
  • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,
  • LH and FSH levels in the post-menopausal range for women under 50,
  • Radiation-induced oophorectomy with last menses \>1 year ago,
  • Chemotherapy-induced menopause with \>1 year interval since last menses,
  • Or surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • Both men and women (of childbearing potential) who are sexually active should accept to use adequate contraception, during and for at least 6 months post-treatment
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus

Villejuif, Val de Marne, 94805, France

RECRUITING

Related Publications (1)

  • Postel-Vinay S, Coves J, Texier M, Aldea M, Gazzah A, Domine M, Planchard D, De Las Penas R, Sala Gonzalez MA, Viteri S, Perez J, Ortega AL, Moran T, Camps C, Lopez-Martin A, Provencio M, Soria JC, Besse B, Massuti B, Rosell R. Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trial. Br J Cancer. 2024 Feb;130(3):417-424. doi: 10.1038/s41416-023-02514-5. Epub 2023 Dec 14.

    PMID: 38097741DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

olaparib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Sophie Postel-Vinay, MD

CONTACT

0142114343sophie.postel-vinay@gustaveroussy.fr

Valérie Mairot

CONTACT

0142113730Valerie.mairot@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 11, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)