A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of Gemcitabine Plus Cisplatin as (Neo)Adjuvant Treatment in Stage IIIA-N2 Non-small-cell Lung Cancer With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING)
Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but
its treatment-related life threaten toxicity limit its use for those pts.
Tarceva monotherapy have been demonstrated a significant improvement in overall survival and
disease progression free survival when used for the treatment of patients with metastatic
NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated
without the side effects usually associated with chemotherapy.
Based on the encouraging results reported from the SLCG phase II study reported the efficacy
of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would
prolong overall survival, delay disease progression and be well tolerated, mOS reached 27
months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo,
Tarceva may provide an important treatment alternative for local advanced pts with EGFR
In IPASS study (gefitinib or carboplatin/paclitaxel in pulmonary adenocarcinoma as first
line treatment), the subgroup of 261 patients who were positive for the epidermal growth
factor receptor gene (EGFR) mutation, progression-free survival was significantly longer
among those who received gefitinib than among those who received carboplatin-paclitaxel
(hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001).
In OPTIMAL study (first-line erlotinib versus carboplatin/gemcitabine in Chinese advanced
NSCLC patients with EGFR activating mutations), the primary analysis showed PFS was
significantly prolonged with erlotinib vs carboplatin/paclitaxel(13.1months vs 4.6 months,
HR 0.16 ; p<0.0001). The objective response rate was significantly improved with erlotinib
vs carboplatin/paclitaxel (83% vs 36%, p=0.0000), as was the disease control rate (CR + PR +
SD; 96 vs 82%; p=0.002).
The aim of this study is to investigate the efficacy and safety of Tarceva versus
combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage
IIIA- N2 NSCLC with EGFR activating mutation in exon 19 or 21.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The objective response rate (ORR) in neoadjuvant treatment
To evaluate objective response rate (ORR) of Erlotinib versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment for stage IIIA- N2 NSCLC with EGFR activating mutation in exon 19 or 21.
Tumor response will be evaluated after 6 weeks of induction treatment (during day 43 to day 49).
Yi-Long WU, MD
Guangdong Lung Cancer Institute
China: Ethics Committee