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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
CH
Aix-en-Provence, France
CH
Amiens, France
CHRU
Angers, France
CH
Annecy, France
CHU
Brest, France
Centre François BACLESSE
Caen, France
CHIC
Créteil, France
CH
Draguignan, France
CH
Elbeuf, France
CHIC
Gap, France
...and 25 more locations
Efficacy by PFS
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.
Time frame: From date of randomization until the date of first documented progression evaluated every 6-9 weeks
scores of QoL
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.
Time frame: at 4 months after inclusion
Overall survival
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
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Tumoral response
Tumoral response (complete response, partial response, stable disease, progression) according to RECIST 1.1
Time frame: every 6-9 weeks
Toxicities
Toxicities according to NCI-CTC-AE v.4
Time frame: From date of randomization until study participation, assessed up to 100 months
Rebound phenomenon (flare)
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
Time frame: within 3 weeks after disease progression before inclusion
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