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

Conditions

• NSCLC Patients With EGFR Activating Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ERLOTINIB WITH CHEMOTHERAPY — DRUG
• CHEMOTHERAPY ONLY — DRUG

Study Details

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.

Key Dates

First listed

Jun 30, 2014

Start date

Jun 30, 2014

Status verified

Jul 2016

Primary completion

Sep 30, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

6 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EXPERIMENTAL ARM B
  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
• Active Comparator: STANDARD ARM A
  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

Primary Outcome Measure

Efficacy by PFS [ Time Frame: From date of randomization until the date of first documented progression evaluated every 6-9 weeks ]