Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01631136

Enrollment

932

Registered

2012-06-28

Start date

2012-07-31

Completion date

2017-11-30

Last updated

2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, IFCT, Maintenance, Switch

Brief summary

In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease. There is two types of maintenance strategies: * Continuous maintenance : prolongation of the treatment initially associated with platin until progression * Switch maintenance : introduction of a new treatment after the end of induction chemotherapy The aim of this study is to compare two maintenance strategies * A continuous maintenance by pemetrexed * A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.

Interventions

DRUGCisplatin

75 mg/m²

DRUGPemetrexed

500 mg/m²

DRUGGemcitabine

1250 mg/m²

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Non-squamous NSCLC histologically or cytologically confirmed * Stage IV with a cytologically or histologically confirmation for an unique metastasis * No EGFR activating mutation or indeterminate EGFR mutational status * At least one measurable lesion * Age between 18 and 70 * PS 0 or 1

Exclusion criteria

* squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer * Knowledge of ALK gene rearrangement * Symptomatic central nervous system metastases or requiring immediate cerebral radiotherapy * Superior venous cave syndrome except if treated by implantation of a prosthesis * Previous anti-tumoral treatment * Concomitant radiotherapy

Design outcomes

Primary

Measure	Time frame
Overall survival	around 20 months

Secondary

Measure	Time frame	Description
Disease free survival	Around 5 months	—
Control and response rate	After 4 cycles	—
Safety analysis	Around 5 months	Number of patients with at least one adverse event in each arm and number of adverse events with the relationship, intensity and the cycle of appearance
treatment exposure	Around 5 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026