Neoplasms

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Carboplatin

Pemetrexed

Cisplatin

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

INDUCTION chemotherapy: 4 cycles of

* pemetrexed with cisplatin or carboplatin
* or gemcitabine with cisplatin or carboplatin in combination with erlotinib

THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed in combination with erlotinib

INDUCTION chemotherapy: 4 cycles of

* pemetrexed with cisplatin or carboplatin
* or gemcitabine with cisplatin or carboplatin

THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed

ERLOTINIB WITH CHEMOTHERAPY

CHEMOTHERAPY ONLY

Radj GERVAIS, MD

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.

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

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.

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 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 (complete response, partial response, stable disease, progression) according to RECIST 1.1

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

Groupe Francais De Pneumo-Cancerologie

Hoffmann-La Roche

Centre Francois Baclesse

Spots Global Cancer Trial Database for erlotinib with chemotherapy