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Stage IV, NSCLCPhase 3EPICNCT03402048

The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial

A Phase 3 study testing Carboplatin, Gemcitabine and Pemetrexed in people with Stage IV, NSCLC and Lung Neoplasms, run by University of Turin, Italy at 28 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Carboplatin, Gemcitabine and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
28 sitesItaly
Study dates
Jul 2012to May 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically or cytologically confirmed NSCLC.
  • Stage IV NSCLC by the AJCC Staging Manual 7th edition (2010).
  • Measurable or evaluable disease by RECIST 1.1.
  • Age equal or more than 70 years.
  • Performance Status 0 or 1 (by ECOG criteria).
  • Adequate bone marrow function.
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  • Signed informed consent document (ICD).
  • Men with partners in the childbearing age group must use effective contraception.
  • Previous surgery for NSCLC (more than 30 days before study registration) is allowed.
  • Previous radiotherapy is allowed if: the time between completion of RT and initiation of study treatment is at least 7 days,the patient has fully recovered from all toxic effects, and at least one target lesion or evaluable disease is outside the radiation field.
  • Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a curative intent surgical resection for a NSCLC. Patient should be previously untreated for metastatic disease.
  • Patients with stable brain metastases will be allowed to enroll. Stable brain metastasis is defined as no progression of brain metastases 14 days after conclusion of definitive treatment as documented by a CT scan or MRI of the brain.

Who cannot join

  • Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
  • Prior malignancies, except: cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years.
  • Presence of uncontrolled brain or leptomeningeal metastases.
  • Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v 4.0 except if due to trauma.
  • Other serious illness or medical condition, including but not limited to: congestive heart failure;myocardial infarction within 6 months;significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician; infection requiring I.V. antibiotics; tuberculosis with ongoing therapy at study entry, superior vena cava syndrome, except if controlled with radiation, active peptic ulcer disease; unstable diabetes mellitus;any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease.
  • Hypercalcemia requiring therapeutic intervention.
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  • Clinically significant ascites and/or pericardial effusion.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • Concurrent treatment with other investigational drugs.
  • Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol.
  • Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded.
  • Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.

Trial locations and contacts

28 sites in 1 country.

Silvia Novello, MD,PhD contact

+390119026978

silvia.novello@unito.it

28 sites in 1 country

Italy28 sites, 28 recruiting

  • Istituto Nazionale Tumori

    Aviano, Pordenone

    Alessandra Bearz, MD

    Recruiting

  • Ospedale Giovanni Paolo II

    Bari

    Domenico Galetta, MD

    Recruiting

  • AO Cannizzaro

    Catania

    Giuseppe Banna, MD

    Recruiting

  • AUSL Rimini-Oncologia Medica Cattolica

    Cattolica, Rimini

    Maximilian Papi, MD

    Recruiting

  • AOU Santa Croce e Carle

    Cuneo

    Ida Colantonio, MD

    Recruiting

  • Ospedale di Faenza

    Faenza, Ravenna

    Alessandro Gamboni, MD

    Recruiting

  • Azienda Ospedaliera Careggi

    Florence

    Fabiana Cecere, MD

    Recruiting

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova

    Francesco Grossi, MD

    Recruiting

  • Ospedale Galliera

    Genova

    Carlotta Defferrari, MD

    Recruiting

  • Ospedale di Lugo

    Lugo, Ravenna

    Gianni Michele Turolla, MD

    Recruiting

  • IRCSSIstituto Scientifico Romagnolo per lo studio e la cura dei tumori IRST

    Meldola, Forlì

    Marco Angelo Burgio, MD

    Recruiting

  • Azienda Ospedaliera Fatebenefratelli

    Milan

    Gabriella Farina, MD

    Recruiting

  • Ospedale S. Raffaele

    Milan

    Vanesa Gregorc

    Recruiting

  • AO San Gerardo

    Monza

    Paolo Bidoli, MD

    Recruiting

  • AOU San Luigi Gonzaga, Department of Oncology, University of Turin

    Orbassano, Turin, 10043

    Silvia Novello, MD, PhD, +390119026978, silvia.novello@unito.it

    Recruiting

  • Istituto Oncologico Veneto

    Padova

    Adolfo Favaretto, MD

    Recruiting

  • Ospedale Santa MAria della Misericordia

    Perugia

    Lucio Crinò, MD

    Recruiting

  • Ospedale S MAria delle Croci

    Ravenna

    Claudio Dazzi, MD

    Recruiting

  • Arcispedale Santa Maria Nuova

    Reggio Emilia

    Corrado Boni, MD

    Recruiting

  • AUSL Rimini-Oncologia medica

    Rimini

    Maximilian Papi, MD

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma

    Francesco Cognetti, MD

    Recruiting

  • Ospedale S. Giovanni Addolorata

    Roma

    oLGA Martelli, MD

    Recruiting

  • Policlinico Umberto I- Università la Sapienza

    Roma

    Enrico Cortesi, MD

    Recruiting

  • AOU Sassari

    Sassari

    Lorenzo Cordero, MD

    Recruiting

  • Azienda Ospedaliera Sondalo

    Sondalo

    Giuseppe Valmadre, MD

    Recruiting

  • Ospedale Santa Chiara

    Trento

    Orazio Caffo, MD

    Recruiting

  • AOU S.M. Misericordia

    Udine

    Alessandro Follador, MD

    Recruiting

  • AOU Verona

    Verona

    Gianpaolo Tortora, MD

    Recruiting

Other trials in Italy

About this study

Official title: Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer

This is a randomized phase III trial that will randomize elderly patients(70 years of age and older) who are not considered eligible for standard doublet or triplet regimens. In a 2:1 fashion, patients will be randomized to the customization arm or the standard arm, respectively. This trial will be offered to patients who are previously untreated for stage IV NSCLC.

The primary objective is to evaluate if chemotherapy selection based on histology and tumoral molecular determinants ERCC1, RRM1 and TS (arm A, the experimental arm) results in superior outcome in elderly patients with untreated, advanced NSCLC compared to standard of care treatments (arm B, the standard arm).

Read the detailed description

The study population will consist of patients with histologically or cytologically proven stage IV NSCLC, who have not been previously treated with chemotherapy for stage IV and are either elderly (70 years of age and older). Patients must fulfill all the inclusion/exclusion criteria to be eligible.

Tissue will be obtained, and gene expression analysis will be performed at the University of Turin. The tissue sample used for this analysis will be obtained from the biopsy procedure performed as standard of care procedures during the patient's diagnosis and staging. Patients will be randomized to either Arm A: Experimental or Arm B: Standard of Care in a 2:1 fashion.

Tissue will be obtained for gene analysis for ALL patients. However, ONLY patients randomized to Arm A will receive the genetic analysis results. Genetic results will not be disclosed to the registering center for those patients randomized to Arm B: Standard of Care.

For patients randomized to Arm A: Experimental arm, the chemotherapy treatment prescription will be based on the gene analysis according to the protocol. For patients randomized to Arm B: Standard of Care arm, the chemotherapy treatment will be at the discretion of the care provider.

Keywords
Lung Cancer, Elderly, First line, Customized chemotherapy, Pharmacogenomic-driven, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Bronchial Neoplasms, Carcinoma, Bronchogenic, Lung Diseases, Neoplasms, Respiratory Tract Diseases, Respiratory Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03402048
Study groupRoleWhat they receive
control armActive comparatorAt discretion of the treating phisician. Common chemotherapic regimens include: Gemcitabine at 1000 or 1250 mg/m2 IV (in the vein) on day 1 and 8 of each 21 day cycle. Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 and 8 of each 21 day cycle. Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed 500mg/m2 on day 1 IV on Day 1 of each 21 day cycle. Vinorelbine 30 mg/m2 IV on day 1 and day 8 every 3 of each 21 day cycle. Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Docetaxel; Drug: Vinorelbine
experimental armExperimentalTreatment prescriptions will be based on gene analysis: * Carboplatin at an AUC of 6 IV (in the vein) on day 1 of each 21 day cycle. * Gemcitabine at 1000 mg/m2 IV on day 1 and 8 of each 21 day cycle. * Carboplatin at an AUC of 5 IV on day 1 of each 21 day cycle plus Gemcitabine at 1000 mg/m2 IV on Day 1 of each 21 day cycle. * Carboplatin at an AUC of 5 IV on Day 1 of each 21 day cycle plus Pemetrexed at 500 mg/m2 IV on Day 1 of each 21 day cycle. * Pemetrexed 500mg/m2 IV on Day 1 of each 21 day cycle. * Docetaxel 75 mg/m2 IV on Day 1 of each 21 day cycle. Or Vinorelbine 30 mg/m2 IV on day 1 and day 8 of each 21 day cycle. Number of Cycles: to a maximum of 6 cycles until progression or unacceptable toxicity.
Receives: Drug: Carboplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Docetaxel; Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    primary endpoint is OS (determined from the date of randomization).Assuming an exponential survival distribution for both treatment arms and a median survival time of 8 months in the control arm we anticipate to detect an improvement of three months in OS.

    Measured: from the date of randomization

Secondary outcomes (1)

  1. Progression Free survival

    PFS at 6 months (determined from the date of randomization). The anticipated 6-month PFS in arm B is approximately 25% and the goal in the experimental arm is to achieve a 32% improvement to 33%.

    Measured: at six months determined from the date of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study startJul 2012
  3. Primary completionDec 2020 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
567 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03402048
Sponsor's protocol ID
2012-001194-81
Acronym
EPIC
Status last verified
Nov 2020
First submitted
17 Nov 2014
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Gemcitabine and Pemetrexed in people with Stage IV, NSCLC and Lung Neoplasms, run by University of Turin, Italy at 28 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Silvia Novello, MD,PhD (+390119026978, silvia.novello@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: from the date of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03402048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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