Therapy with gefitinib followed by conventional chemotherapy in certain tumor patients.

Phase 1

• Conditions: Patients with stage II, IIIA and IIIB non-squamous non-small-cell lung cancer with activating EGFR mutation; MedDRA version: 19.0Level: PTClassification code 10073254Term: Neoadjuvant therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005595-28-DE
• Lead Sponsor: AIO-Studien-gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with histologically or cytologically confirmed non-squamous non-small-cell lung cancer (NSCLC) stage II, IIIA and IIIB detected preoperatively by adequate methods and activating EGFR mutation in exons 18-21. Stage should be confirmed by PET-CT as well as adequate mediastinal staging. Routine MRI of the brain to exclude CNS-metastases is mandatory before enrolment according to standard guidelines.

2. At least one unidimensionally measurable lesion meeting RECIST criteria (version 1.1)

3. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale

4. Estimated life expectancy of at least 12 weeks

5. Patients aged = 18 years

6. Adequate organ function including the following:

a) Adequate bone marrow reserve:
– absolute neutrophils (segmented and bands) count (ANC) =1.5x10e9/L;
– platelets =100x10e9/L;
– haemoglobin =9 g/dL.

b) Hepatic:
– bilirubin = 1xULN;
– alkaline phosphatase (AP) = 2.5xULN;
– aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5xULN.

c) Renal:
– serum creatinine = 1.3 mg/dL;
– glomerular filtration rate = 70 mL/min (calculated) for cisplatinum based CTx. If contraindications including GFR below 70mL/min against cisplatin exist, carboplatin may also be used.
- glomerular filtration rate = 30 mL/min (calculated) if carboplatin is to be used

7. Cooperation and willingness to complete all aspects of the study

8. Written informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

3. Pre-existing neuropathia = grade 2 (NCI CTCAE V4.03)

5. Patients with confirmed HIV infection

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 women, women 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 pessars (only hormonal devices), sexual abstinence or vasectomy of the partner). Women of childbearing potential must have a negative pregnancy test (serum ß-hCG) at Pre-Screening and Screening.

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 of previously used trial medication, 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 recruited 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

14. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified