Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01631136 |
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Recruitment Status :
Completed
First Posted : June 28, 2012
Last Update Posted : January 17, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Non Small Cell Lung Cancer | Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 932 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | July 2012 |
| Actual Primary Completion Date : | May 2, 2017 |
| Actual Study Completion Date : | November 30, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
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Drug: Cisplatin
75 mg/m² Drug: Pemetrexed 500 mg/m² |
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Experimental: Maintenance according to the response of induction
Induction chemotherapy by cisplatin + gemcitabine followed by :
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Drug: Pemetrexed
500 mg/m² Drug: Cisplatin 80 mg/m² Drug: Gemcitabine 1250 mg/m² |
- Overall survival [ Time Frame: around 20 months ]
- Disease free survival [ Time Frame: Around 5 months ]
- Control and response rate [ Time Frame: After 4 cycles ]
- Safety analysis [ Time Frame: 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 [ Time Frame: Around 5 months ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT01631136
Show 91 study locations
| Principal Investigator: | Maurice PEROL, MD | Centre Léon Bérard - Lyon | |
| Principal Investigator: | Pierre-Jean SOUQUET, MD, PhD | Centre Hospitalier Lyon Sud |
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01631136 |
| Other Study ID Numbers: |
IFCT-GFPC-1101 |
| First Posted: | June 28, 2012 Key Record Dates |
| Last Update Posted: | January 17, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Non Small Cell Lung Cancer IFCT Maintenance Switch |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Cisplatin Pemetrexed |
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 Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |