Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

July 13, 2025 updated by: University Hospital, Limoges

A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.

The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

Study Overview

Status

Completed

Conditions

Non Small Cell Lung Carcinoma

Intervention / Treatment

Detailed Description

Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.

Study Type

Interventional

Enrollment

227

Phase

Phase 2

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
- - Beauvais, France
    - Service de pneumologie
  - Bordeaux, France
    - Service de pneumologie
  - Charleville Mezière, France
    - Service de pneumologie
  - Créteil, France
    - Service de pneumologie
  - Draguignan, France
    - Service de pneumologie
  - Elbeuf, France
    - Service de pneumologie
  - Gap, France
    - Service de pneumologie
  - Limoges, France
    - Service de Pathologie Respiratoire
  - Lyon, France
    - Service de Pneumologie, Hôpital de la Croix Rousse
  - Mantes La Jolie, France
    - Service de pneumologie
  - Marseille, France
    - Département des Maladies Respiratoires
  - Martigues, France
    - Service de Pneumologie-Allergologie
  - Meaux, France
    - Service de pneumologie
  - Mulhouse, France
    - Service de pneumologie
  - Paris, France
    - Service de Pneumologie - Hôpital St Antoine
  - Rennes, France
    - Service de Pneumologie, Hôpital Pontchailloux
  - Rouen, France
    - Hôpital Charles Nicolle, Service de Pneumologie
  - Rouen, France
    - Service de Pneumologie, Hôpital Bois Guillaume
  - Toulon naval, France
    - Service de Pathologie Respiratoire
  - Villefranche, France
    - Service de pneumologie
  - saint Etienne, France
    - Service de Pneumologie, Hôpital Nord

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

Description

Inclusion Criteria:

Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
Metastatic relapses allowed in not irradiated area.
Age between 18 and 70 years
Chemonaïve patients
At least one measurable target lesion according to recist criteria in non previously irradiated area.
Performance status < 2
Normal hepatic and renal function, absolute neutrophil count >1,5 giga/l, platelets >100 giga/l.
Written informed consent.
Life expectancy > 12 weeks.

Exclusion Criteria:

SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
Previous chemotherapeutic treatment.
Symptomatic brain metastases.
Superior vena cava syndrome.
Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
Peripheral neuropathy grade ≥2.
Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
Hypersensitivity to paclitaxel or polysorbate 80.
Pregnancy or breast feeding.
Any concomitant radiotherapy, except palliative bone irradiation.
Follow-up of the patient impossible.
Prisoners.

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 Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1-Complete response
2-Partial response
3-Stable disease
4-Progression

Secondary Outcome Measures

Outcome Measure
-Toxicity (NCI-CTC criteria)

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

Collaborators

Groupe Francais De Pneumo-Cancerologie

Investigators

Principal Investigator: Alain Vergnengre, MD, University Hospital, Limoges

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

Vergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff.

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 (Actual)

September 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 13, 2025

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

I03022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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