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Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly Patients With Advanced Non-small Cell Lung Cancer (eNERGY)

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ClinicalTrials.gov Identifier: NCT03351361
Recruitment Status : Not yet recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option.

Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy.

Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival.

In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study.

The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.


Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Drug: Nivolumab + Ipilimumab Drug: Chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly (More Than 70 Years Old) Patients With Advanced Non-small Cell Lung Cancer
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab Drug: Nivolumab + Ipilimumab
Nivolumab dosed intravenously over 30 minutes at 240 mg every 2 weeks combined with Ipilimumab dosed intravenously over 30 minutes at 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol.

Active Comparator: Chemotherapy
carboplatin and pemetrexed or carboplatin and paclitaxel
Drug: Chemotherapy
Doublet of chemotherapy according to standard of care carboplatin (AUC 5) with a dose that will be capped to 700 mg and pemetrexed (500 mg/m²) over 4 to 6 hours every three weeks (restricted to non-squamous histology) or carboplatin (AUC 6) with a dose that will be capped to 700 mg and paclitaxel (90 mg/m²) D1 D8 D15 over 4 to 6 hours every 4 weeks, with a maximum of 4 cycles of carboplatin based doublet, and the possibility to use maintenance with pemetrexed.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum ]

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 1 year ]
  2. Objective response rate [ Time Frame: 2 years ]
    according to RECIST 1.1

  3. Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]
  4. Safety [ Time Frame: 2 years ]
    according to CTCAE version 4.0

  5. Tolerability [ Time Frame: 2 years ]
    according to CTCAE version 4.0

  6. Quality of life [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]
    according to EQ-5D questionnaire

  7. Quality of life [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]
    according to EORTC QLQ-ELD14 questionnaire

  8. PD-L1 [ Time Frame: 2 years ]
    testing by immunochemistry

  9. Geriatric evaluation [ Time Frame: inclusion and 2 months ]
    according to geriatric mini data set



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Cytologically or histologically proven NSCLC (adenocarcinoma, squamous cell carcinoma, large-cell carcinoma)
  • Stage IV or non-treatable by radiotherapy or surgery stage III (7th classification)
  • No previous systemic chemotherapy for lung cancer, except in case of relapse after adjuvant treatment for localized disease with 6 months or more between end of previous chemotherapy and relapse
  • Patients less than 70 years old and PS 2 or 70 years older PS 0 to 2
  • Judged fit enough to receive a carboplatin based doublet according to ESMO guidelines
  • Presence of at least one measurable target lesion (RECIST 1.1 rules) in a non-irradiated region and analysable by CT
  • Life expectancy superior at 12 weeks
  • Prior radiation therapy is authorized if it involved less than 25% of the total bone marrow volume and finished 14 days before D1 of planned treatment
  • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization/registration WBC superior or equal at at 2000/μL Neutrophils superior or equal at at 1500/μL Platelets superior or equal at at 100 x103/μL Hemoglobin superior at 10.0 g/dL Serum creatinine inferior or equal at 1.5 x ULN or creatinine clearance (CrCl) superior or equal at at 45 mL/min (if using the Cockcroft-Gault formula ) AST/ALT inferior or equal at 3 x ULN Total Bilirubin inferior or equal at 1.5 x ULN (except Patients with Gilbert Syndrome, who can have total bilirubin inferior at 3.0 mg/dL)
  • Availability of adequate FFPE tumor-derived material (tumor blocks or slides) from a biopsy, surgery or fine needle aspirate for analysis of PD-L1 testing by IHC

Age and Reproductive Status

• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during treatment.

WOCBP should use an adequate method to avoid pregnancy :

  • For 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of nivolumab + ipilimumab,
  • For 4 weeks after the last dose of carboplatine + pemetrexed,
  • For 5 weeks after the last dose of carboplatine + paclitaxel.

    • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of treatment
    • Women must not be breastfeeding
    • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during treatment Men will be instructed to adhere to contraception for a period of 31 weeks after the last dose of nivolumab + ipilimumab and with carboplatine +pemetrexed or carboplatine + paclitaxel up to 6 months thereafter.

Exclusion Criteria:

  • Patients with other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, coronarian or peripheric arterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections) are not eligible.
  • Serious or uncontrolled systemic disease judged as incompatible with the protocol by the investigator
  • Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ, or appropriately treated localized low-grade prostate cancer (Gleason score inferior at 6), unless the initial tumor was diagnosed and definitively treated more than 5 years previously, with no evidence of relapse.
  • Known activating mutation of EGFR (del LREA exon 19, mutation L858R or L861X of exon 21, mutation G719A/S in exon 18) or EML4-ALK or ROS-1 translocation
  • Superior at caval syndrome
  • Uncontrolled infectious status
  • All concurrent radiotherapy
  • Concurrent administration of one or several other anti-tumor therapies.
  • Psychological, familial, social or geographic difficulties preventing follow-up as defined by the protocol.
  • Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
  • Concurrent participation in another clinical trial
  • Patients are excluded if they have active brain metastases or leptomeningeal metastases. Patients with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for [lowest minimum is 4 weeks or more] after treatment is complete and within 28 days prior to the first dose of nivolumab and ipilimumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (superior at 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
  • Patients should be excluded if they have an active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (superior at 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses superior at 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  • Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Patients should be excluded if they have a lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Allergies and Adverse Drug Reaction
  • History of allergy to study drug components
  • Severe spinal hypoplasia and / or hemorrhagic tumors

Information from the National Library of Medicine

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): NCT03351361


Contacts
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Contact: Hervé Léna, Md 33 2 99 28 37 38 herve.lena@chu-rennes.fr
Contact: Anne Ganivet 33 2 99 28 25 55 anne.ganivet@chu-rennes.fr

Locations
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France
CH du Pays d'Aix Not yet recruiting
Aix-en-Provence, France
Contact: Jacques Letreut         
CHU d'Angers Not yet recruiting
Angers, France
Contact: Thierry Urban         
CH de la Côte Basque Not yet recruiting
Bayonne, France
Contact: Marielle Sabatini         
CH de Beauvais Not yet recruiting
Beauvais, France
Contact: Jacky Crequit         
CHU de Brest Not yet recruiting
Brest, France
Contact: Gilles Robinet         
Centre Francois Baclesse Not yet recruiting
Caen, France
Contact: Radj Gervais         
CH René Dubos Not yet recruiting
Cergy-Pontoise, France
Contact: Gislaine Fraboulet         
CH de Charleville-Mézières Not yet recruiting
Charleville-Mézières, France
Contact: Stéphane Chouabe         
CH Intercommunal Not yet recruiting
Créteil, France
Contact: Isabelle Monnet         
CH Intercommunal des Alpes du Sud Not yet recruiting
Gap, France
Contact: Pascal Thomas         
CH Départemental Vendée Not yet recruiting
La Roche-sur-Yon, France
Contact: Marie Marcq         
CH de Versailles Not yet recruiting
Le Chesnay, France
Contact: Cécile Dujon         
CH Robert Boulin Not yet recruiting
Libourne, France
Contact: Menouar-Samir Abdiche         
CHU de Limoges Not yet recruiting
Limoges, France
Contact: Alain Vergnenegre         
CH Régional Not yet recruiting
Longjumeau, France
Contact: Gérard Oliviero         
CH de Bretagne Sud Not yet recruiting
Lorient, France
Contact: Régine Lamy         
Centre Léon Bérard Not yet recruiting
Lyon, France
Contact: Maurice Perol         
CH François Quesnay Not yet recruiting
Mantes-la-Jolie, France
Contact: Jean-Bernard Auliac         
APHM Hôpital Nord Not yet recruiting
Marseille, France
Contact: Laurent Greillier         
Institut Paoli-Calmette Not yet recruiting
Marseille, France
Contact: Anne Madroszyk-Flandin         
CH de Meaux Not yet recruiting
Meaux, France
Contact: Chrystèle Locher         
CH de la Région d'Annecy
Pringy, France
CHU de Rennes Not yet recruiting
Rennes, France
Contact: Hervé Léna         
Sub-Investigator: Romain Corre         
Principal Investigator: Hervé Léna         
CHU de Rouen Not yet recruiting
Rouen, France
Contact: Luc Thiberville         
CH de Saint-Brieuc Not yet recruiting
Saint-Brieuc, France
Contact: Gwenaëlle Le Garff         
CHU de Saint-Etienne Not yet recruiting
Saint-Priest-en-Jarez, France
Contact: Pierre Fournel         
CLCC Paul Strauss Not yet recruiting
Strasbourg, France
Contact: Roland Schott         
CH Intercommunal Toulon-La Seyne-sur-Mer Not yet recruiting
Toulon, France
Contact: Clarisse Audigier-Valette         
HIA Saint-Anne Not yet recruiting
Toulon, France
Contact: Henri Berard         
CH de Villefranche sur Saône Not yet recruiting
Villefranche-sur-Saône, France
Contact: Lionel Falchero         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Hervé Léna CHU Rennes
  Study Documents (Full-Text)

Documents provided by Rennes University Hospital:
Informed Consent Form  [PDF] November 6, 2017


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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03351361     History of Changes
Other Study ID Numbers: 2017-002842-60
35RC16_9734 ( Other Identifier: CHU Rennes )
08-2015 ( Other Identifier: GFPC )
CA209-449 ( Other Identifier: BMS )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Carboplatin
Nivolumab
Ipilimumab
Antineoplastic Agents
Antineoplastic Agents, Immunological