Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB

1. EGFR wild type configuration;

2. EGFR resistance mutations (i.e. T790M);

3. Significant cardiovascular disease, such as uncontrolled hypertension, myocardial infarction within the last 6 months, unstable angina pectoris, CHF ≥ NYHA 2, serious arrhythmia, significant peripheral vascular disease;

4. Pre-existing neuropathic ≥ grade 2;

5. Patients with confirmed HIV infection. HIV testing is not mandatory.

6. Prior history of malignancy except for basal cell carcinoma or carcinoma in situ of the cervix, and with the exception of other malignancies after curative treatment with an interval of at least 3 years.

7. Lactating or pregnant woman, woman of child-bearing potential who do not agree to the usage of highly effective contraception methods (allowed methods of contraception, meaning methods with a rate of failure of less than 1% per year are implants, injectable contraceptives, combined oral contraceptives, intrauterine devices (only hormonal devices), sexual abstinence or vasectomy of the partner). Woman of childbearing potential must have a negative pregnancy test (serum β-HCG) at visit 1.

8. Any other chemotherapy at start;

9. Treatment with other experimental drugs during the course of the study or within the last 30 days or 7 half-lifes, whatever is of longer duration, prior study start;

10. Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial;

11. Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes, whatever is of longer duration, prior study start;

12. Patient has already been included in this trial;

13. Patients who do not understand the nature, the scope and the consequences of the clinical trial;

14. Affected persons who might be dependent on the sponsor or the investigator.

What this study is about