A Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as treatment re-challenge in Patients, who have Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting

• Conditions: on small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005157-31-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

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

Inclusion Criteria

Provision of informed consent prior to any study specific procedures
2. Histologically or cytologically confirmed NSCLC with an activating sensitising
EGFR TK mutation as it was determined before starting the first gefitinib treatment
by using a well-validated and robust methodology: adenocarcinoma, including
Bronchoalveolar Carcinoma (BAC), squamous cell carcinoma, large cell carcinoma,
adenosquamous carcinoma or undifferentiated carcinoma or not-otherwise specified
NSCLC.
3. Female or male patients aged 18 years or over with Locally advanced or metastatic
stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV
(metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who
have already received gefitinib with a documented complete (CR) or partial
response (PR) or stable disease (SD) >12 weeks as the best response to their 1st
gefitinib treatment and progressing during or after a subsequent anti-cancer therapy
(excluding EGFR-TKIs) treatment, including but not limited to doublet platinum
based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy.
4. Measurable disease defined as at least one lesion, not previously irradiated, that can
be accurately measured at baseline as = 10 mm in the longest diameter (except
lymph nodes which must have short axis = 15 mm) with spiral CT or MRI and
which is suitable for accurate repeated measurements.
5. WHO / ECOG / Zubrod performance status 0-2.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

1. Known severe hypersensitivity to gefitinib or any of the excipients of the product
Prior EGFR TKIs except gefitinib followed by subsequent anti-cancer treatment
(including chemotherapy and excluding EGFR-TKIs). Previous adjuvant
chemotherapy is allowed. Prior surgery or radiotherapy must be completed more
than 6 months before start of study treatment. Palliative radiotherapy must be
completed at least 4 weeks before start of study treatment with no persistent
radiation toxicity.
3. Progression disease or stable disease (SD) <12 weeks as best response to the 1st line
treatment with gefitinib
4. Not progressing during or after the last anti-cancer treatment.
5. Considered to require radiotherapy to the lung at the time of study entry or in the
near future
6. Past medical history of interstitial lung disease, drug-induced interstitial disease,
radiation pneumonitis which required steroid treatment or any evidence of clinically
active interstitial lung disease
7. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
8. Insufficient lung function as determined by either clinical examination or an arterial
oxygen tension (PaO2) of < 70 Torr
9. Known or suspected brain metastases or spinal cord compression, unless treated
with surgery and/or radiation and stable without steroid treatment for at least 4
weeks prior to the first dose of study medication
10. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
therapy
11. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine,
rifampicin, barbiturates, or St John's Wort
12. Pregnancy or breast-feeding
13. As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal
disease)
14. Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study
15. Other co-existing malignancies or malignancies diagnosed within the last 5 years
with the exception of basal cell carcinoma or cervical cancer in situ
16. Life expectancy of less than 12 weeks
17. Treatment with a non-approved or investigational drug within 30 days before Day 1
of study treatment
18. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site)
19. Previous enrolment or treatment in the present study.

Study & Design

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