NCT01784549

Brief Summary

  • The investigators hypothesized that NSCL patients receiving therapy based on their baseline tumor markers levels would attain higher response rates than patients in the control arm receiving non customized therapy.
  • patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard chemotherapy.
  • The primary objective of this multicenter trial is to compare pathological complete response of all subjects randomized, by treatment arm.
  • Secondary objectives are to compare all randomized subjects by treatment arm for: response rate, disease-free survival, overall survival, one, two and three year survival and safety profile. The study is expected to demonstrate both the feasibility of this approach and the logistic problems associated with a biomarker-driven therapeutic strategy in NSCLC.

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
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2012

Typical duration 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

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

3.3 years

First QC Date

February 2, 2013

Last Update Submit

November 23, 2014

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLbiomarkersCustomized Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response

    30 days

Secondary Outcomes (3)

  • Overall Survival (OS)

    at 1, 2, and 5 years

  • Disease-Free Survival (DFS)

    at 1, 2, and 5 years

  • Overall Response (OR)

    at 1, 2, and 5 years

Study Arms (2)

Cisplatin Docetaxel

ACTIVE COMPARATOR

\- Cisplatin + Docetaxel day 1 q 21 days for 3 cycles

Drug: Cisplatin Docetaxel Gefitinib Pemetrexed Vinorelbine Gemcitabine

Gefitinib Pemetrexed Vinorelbine Gemcitabine

EXPERIMENTAL

* Gefitinib day for 8 wks; * Pemetrexed day 1 q 21 days for 3 cycles; * Docetaxel day 1 + Vinorelbine days 1,8 q 21 days for 3 cycles; * Docetaxel days 1,8 + Gemcitabine days 1,8 q 21 days for 3 cycles; * Cisplatin + Docetaxel day 1 q 21 days for 3 cycles; * Cisplatin day 1+ Gemcitabine days 1,8 q 21 days for 3 cycles;

Drug: Cisplatin Docetaxel Gefitinib Pemetrexed Vinorelbine Gemcitabine

Interventions

Cisplatin Docetaxel Gefitinib Pemetrexed Vinorelbine GemcitabineDRUG
Cisplatin DocetaxelGefitinib Pemetrexed Vinorelbine Gemcitabine

Eligibility Criteria

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

You may qualify if:

  • Provision of a signed and dated written informed consent document prior to any study specific procedures.
  • Age ≥18 years, male or female.
  • Histologically confirmed NSCLC.
  • Specimen tumor tissue obtained from mediastinoscopy
  • ECOG Performance status (PS) 0-1.
  • Stage IIIA(N2) patients with technical operable disease limited to T1a,b, T2a,b N2 M0; T3 (\>7 cm) N2 M0.
  • Medically fit for resection by lobectomy or pneumonectomy.
  • Radiologically measurable disease (RECIST v1.1 criteria).
  • Prior surgery for NSCLC if resected ≥5 years.
  • No prior chemotherapy, targeted-therapy, investigational therapy or radiation for NSCLC.
  • No uncontrolled medical problems.
  • No superior vena cava syndrome.
  • Peripheral neuropathy must be ≤ grade 1.
  • Acceptable hematologic and chemistry parameters.
  • Creatinine clearance \>50 ml/min.
  • +3 more criteria

You may not qualify if:

  • Any evidence of mixed histology including elements of small cell or carcinoid lung cancer.
  • Stage IIIA patients limited to T3 N1 M0; T3 (invasion) N2 M0; T4 N0, N1 M0.
  • Any clinically significant GI abnormalities, which may impair intake, transit or absorption of gefitinib, such as the inability to take oral medication.
  • Current enrollment in another therapeutic clinical trial.
  • Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study.
  • Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
  • Pre-existing idiopathic pulmonary fibrosis evidence by computerized tomography (CT) scan at baseline.
  • Uncontrolled or significant CV disease, including: myocardial infarction within 12 months; uncontrolled angina within 6 months; congestive heart failure within 6 months; diagnosed or suspected congenital long QT syndrome;
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
  • Prolonged QTc interval on pre entry ECG.
  • Any history of second or third degree heart block (may be eligible if currently have a pacemaker);
  • Heart rate \<50/minute on baseline ECG;
  • Uncontrolled hypertension.
  • Evidence of prior malignancy (other than non melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with PSA \< ULN) within the last 3 years.
  • Other severe acute or chronic medical condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francesco Grossi, MD

    IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Grossi, MD

CONTACT

+393355255484fg1965@libero.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Lung Cancer Unit

Study Record Dates

First Submitted

February 2, 2013

First Posted

February 6, 2013

Study Start

July 1, 2012

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

IT(1)