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The EPIC Trial The Elderly Patient Individualized Chemotherapy Trial (EPIC)

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ClinicalTrials.gov Identifier: NCT03402048
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Silvia Novello, University of Turin, Italy

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Stage IV, NSCLC Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Drug: Carboplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Docetaxel Drug: Vinorelbine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control arm

At 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.

Drug: Carboplatin
Drug: Gemcitabine
Other Name: Gemzar

Drug: Pemetrexed
Other Name: Alimta

Drug: Docetaxel
Other Name: Taxotere

Drug: Vinorelbine
Other Name: Navelbine

Experimental: experimental arm

Treatment 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.

Drug: Carboplatin
Drug: Gemcitabine
Other Name: Gemzar

Drug: Pemetrexed
Other Name: Alimta

Drug: Docetaxel
Other Name: Taxotere

Drug: Vinorelbine
Other Name: Navelbine




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: from the date of randomization ]
    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.


Secondary Outcome Measures :
  1. Progression Free survival [ Time Frame: at six months determined from the date of randomization ]
    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%.


Other Outcome Measures:
  1. AE and SAE (according to CTCAE version 4.0) [ Time Frame: every week from the day 1 treatment until the end of treatment (up to 18 weeks) ]
    adverse events and serious adverse events as a measure of safety and tolerability

  2. Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document [ Time Frame: up to10 business days of submission of the tumor specimen ]
    Rate of successfully conducted gene expression analysis in patients that have signed the informed consent document



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

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): NCT03402048


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

Locations
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Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Silvia Novello, MD, PhD University of Turin, Italy
Principal Investigator: Giorgio Vittorio Scagliotti, MD, PhD Univerisity of Turin
Principal Investigator: Tiziana Vavalà, MD University of Turin, Italy
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Responsible Party: Prof. Silvia Novello, Principal Investigator, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03402048    
Other Study ID Numbers: 2012-001194-81
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Keywords provided by Prof. Silvia Novello, University of Turin, Italy:
Lung Cancer
Elderly
First line
Customized chemotherapy
Pharmacogenomic-driven
NSCLC
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Thoracic Neoplasms
Respiratory Tract Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Site
Bronchial Diseases
Gemcitabine
Carboplatin
Docetaxel
Pemetrexed
Vinorelbine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors