IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

May 23, 2019 updated by: Hospices Civils de Lyon

A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer Not Progressing on First Line Cisplatin-gemcitabine Chemotherapy Maintenance Chemotherapy With Gemcitabine or Sequential Treatment With Erlotinib

The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

  • Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
  • Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

842

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69317
        • Maurice PEROL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically documented NSCLC (tumor tissue samples will be provided to look for assessment of EGFR status with CISH, immunochemistry and mutations) : adenocarcinoma, squamous cell carcinoma, large cell carcinoma. A cytological documentation of NSCLC is accepted.
  • Stage IV disease or metastatic relapse in not previously irradiated areas of a NSCLC previously treated with surgery or radiation therapy (with a histologically documented proof of relapse) or stage III B with documented pleural involvement.
  • Measurable disease according to the RECIST criteria.
  • Prior radiotherapy authorized except for irradiation concerning measurable disease.
  • Age >18 and < 70 years.
  • PS < 2.
  • Normal hepatic function : serum bilirubin < 1.5 ULN, SGOT (ASAT) and SGPT (ALAT) < 2,5 ULN ; in presence of liver metastases, SGOT and SGPT must be < 5 x ULN.
  • Creatinine clearance > 60 mL/min.
  • Granulocyte count > 1,5 giga/L, platelet count > 100 giga/L.
  • Life expectancy > 12 weeks.
  • Written (signed) informed consent for use of tumors samples.
  • Written (signed) informed consent to participate in the sudy.

Exclusion Criteria:

  • Small cell lung cancer, bronchiolo-alveolar carcinoma, neuro-endocrine carcinoma.
  • PS > 1.
  • Prior chemotherapy other than cisplatin-gemcitabine.
  • Prior therapy with EGFR inhibitor (e.g. monoclonal antibody).
  • No concomitant therapy with phenytoin, carbamazepine, rifampicine or phenobarbital.
  • Concomitant radiotherapy except for localized bone irradiation.
  • Symptomatic brain metastases.
  • Superior vena cava syndrome.
  • Any unstable systemic disease : significant cardiovascular disease including myocardial infarction within the previous year, active infection, significant hepatic or renal disease.
  • Pre-existing interstitial lung disease.
  • Any inflammatory changes of the surface of the eyes.
  • Psychiatric disease with inability to understand the study or to comply with follow-up procedures.
  • Grade > or = 2 peripheral neuropathy.
  • Any other malignancies within 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
  • Pregnant or lactating women ; patients with reproductive potential must use effective contraception.
  • Inability to comply with follow-up procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: A (supervision)
medical supervision, second line chemotherapy if progression
Drug: observation
observation, second line chemotherapy if progression
ACTIVE_COMPARATOR: B (gemcitabicine)
Maintenance treatment (gemcitabicine 1250 mg/m² J1, J8 (repeated cycles every 21 days), second line chemotherapy if progression
Drug: gemcitabine
1250 mg/m² D1, D8 q21 days
EXPERIMENTAL: C (Erlotinib)
Treatment by erlotinib 150 mg/day (sequential treatment), second line chemotherapy if progression
Drug: erlotinib
150 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival since randomization
Time Frame: time until progression
time until progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival,
Time Frame: no time limit
no time limit
toxicity (NCIC-CTC 3.0),
Time Frame: time until progression
time until progression
quality of life (as assessed by LCSS).
Time Frame: until progression
until progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Maurice Pérol, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (ESTIMATE)

March 9, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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