A Phase 2 interventional study of Gefitinib and Fulvestrant in Stage IV Lung Cancer, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 61 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 2, Interventional, and Treatment
Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better
Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.
EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.
The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 379 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Gefitinib · Drug: Fulvestrant
Drug: Erlotinib
Drug: Fulvestrant · Drug: Erlotinib
Drug: Gefitinib
250 mg per day (oral)
500 mg (2 x 250 mg), IV by month with an additional 500 mg dose two weeks after the initial dose
150 mg per day (oral)
progression-free survival
From date of randomization until the date of first progression for EGFR mutated patient
Time frame: Around nine months
Progression free survival
From date of randomization until the date of first progression for EGFR wild type patients
Time frame: Around three months
toxicity of EGFR-TKI and fulvestrant
The number of patients for whom at least an adverse event will have been reported, the number of events, according to the relation to the treatment, the intensity, and the cycle of appearance for EGFR WT patients
Time frame: Around three months
Response rate
For EGFR WT patients
Time frame: Around three months
Overall survival
For all patients
Time frame: Up to 18 months
toxicity of EGFR-TKI and fulvestrant
The number of patients for whom at least an adverse event will have been reported, the number of events, according to the relation to the treatment, the intensity, and the cycle of appearance for EGFR mutated patients
Time frame: Around Nine months
Response rate
For EGFR-Mutated patients
Time frame: Around nine months
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Intergroupe Francophone de Cancerologie Thoracique