A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR (FLARE)
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|ClinicalTrials.gov Identifier: NCT02178397|
Recruitment Status : Terminated (lack of recruitment)
First Posted : June 30, 2014
Last Update Posted : July 17, 2017
The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.
However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.
It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Patients With EGFR Activating Mutation||Drug: ERLOTINIB WITH CHEMOTHERAPY Drug: CHEMOTHERAPY ONLY||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: EXPERIMENTAL ARM B
INDUCTION chemotherapy: 4 cycles of
THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed in combination with erlotinib
Drug: ERLOTINIB WITH CHEMOTHERAPY
Active Comparator: STANDARD ARM A
INDUCTION chemotherapy: 4 cycles of
THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed
Drug: CHEMOTHERAPY ONLY
- Efficacy by PFS [ Time Frame: From date of randomization until the date of first documented progression evaluated every 6-9 weeks ]Efficacy will be assessed by the PFS, define as time between randomization of the patient in the study and disease progression (local, regional, distant and second cancer) or death (all causes). Alive patients free of progression will be censored at the last follow-up.
- scores of QoL [ Time Frame: at 4 months after inclusion ]difference between the scores of QoL at baseline and at 4 months after inclusion for the three targeted dimensions of EORTC QLQ-C30 (global quality of life, fatigue and physical functioning). A difference or 10 points or more at 4 months after inclusion for one score between the 2 arms will be considered as clinically relevant.
- Overall survival [ Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months ]Overall survival defined as time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off
- Tumoral response [ Time Frame: every 6-9 weeks ]Tumoral response (complete response, partial response, stable disease, progression) according to RECIST 1.1
- Toxicities [ Time Frame: From date of randomization until study participation, assessed up to 100 months ]Toxicities according to NCI-CTC-AE v.4
- Rebound phenomenon (flare) [ Time Frame: within 3 weeks after disease progression before inclusion ]Rebound phenomenon (flare) defined by a hospitalization or a death within 3 weeks for disease progression after the end of TKI EGFR treatment (in the arm without EGFR TKI) and date of onset
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): NCT02178397
|Principal Investigator:||Radj GERVAIS, MD||Centre François Baclesse - CAEN- FRANCE|