Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation

The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.

Inclusion Criteria:

1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
2. No previous systemic anticancer therapy.
3. life expectancy more than three months.
4. ECOG Performance Status of 0 to 1.
5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
6. Patients will be required to provide informed consent before enrollment.

Exclusion Criteria:

1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
4. Active concomitant malignancy, and pregnancy or breast-feeding.