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Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment - NVALT 16.


- candidate number14205
- NTR NumberNTR3792
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2013
- Secondary IDs42703.029.12 CCMO
- Public TitleIressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment - NVALT 16.
- Scientific TitleIressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment - NVALT 16.
- ACRONYMIRENE
- hypothesisRe-administration of gefitinib in EGFR-mutated NSCLC patients will increase DCR.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), EGFR mutation
- Inclusion criteria1. Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology;
2. 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 an EGFR-TKI with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st EGFR-TKI treatment and who have received any subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy, on which they progressed;
3. 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;
4. WHO / ECOG / Zubrod performance status 0-2;
5. Possibility of obtaining tumour material before the start of the study treatment.
- Exclusion criteria1. Known severe hypersensitivity to gefitinib or any of the excipients of the product;
2. 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. Previous adjuvant chemotherapy is allowed;
3. Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI;
4. Consideration to require radiotherapy to the lung at the time of study entry or in the near future;
5. 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. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline;
6. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation;
7. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy;
8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort;
9. Pregnancy or breast-feeding;
10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);
11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study;
12. Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ;
13. Life expectancy of less than 12 weeks;
14. Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment;
15. Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site);
16. Previous enrolment or treatment in the present study.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate1-feb-2015
- Target number of participants92
- InterventionsGefitinib 250 mg daily. This will be given untill progression, if informed consent is withdrawn or when adverse events are too heavy.
- Primary outcomeThe primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in patients with activating sensitising Epidermal Growth Factor mutation positive (EGFR M+) NSCLC.
- Secondary outcome1. Objective response rate (ORR) according to RECIST;
2. Progression free survival (PFS) according to RECIST;
3. Overall Survival (OS);
4. EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis. The EGFR mutational status will be compared with EGFR mutational status at diagnosis / before study entry: to this end archival tumour sample or archival tumour DNA sample will be collected;
5. The association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed;
6. mRNA in platelets will be analysed for its predictive value in response to targeted therapies;
7. cfDNA in plasma and serum samples will be analysed on EGFR mutation status.
- TimepointsDCR after 6 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. MD. PhD. E.F. Smit
- CONTACT for SCIENTIFIC QUERIESProf. Dr. MD. PhD. E.F. Smit
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
NVALT Oncology
- PublicationsN/A
- Brief summaryGefitinib is a registered first-line treatment for EGFR-mutated NSCLC patients. There is a lack of evidence for second and third line therapies in this category of patients. Several case reports have described successful re-administration of gefitinib to NSCLC patients who achieved objective response with the initial administration of gefitinib before eventual progression.
It concerns an open label, phase II, multicentre, single arm study and the primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. The secondary objectives of the study are: objective response rate (ORR) according to RECIST, progression free survival (PFS) according to RECIST, overall Survival (OS), EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis and the association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed.
The study will recruit male or female patients aged 18 years or over with histologically confirmed, locally advanced or metastatic (stage IIIB/IV) NSCLC eligible for gefitinib re-challenge treatment who have had a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their previous EGFR-TKI treatment followed by subsequent anti-cancer therapy (excluding EGFR-TKIs). The intervention will be gefitinib 250 mg. Patients will be screened at the outpatient clinic. Follow-up will be every 3 weeks and tumour assessment every 6 weeks. At every visit blood samples will be taken, physical examination will be performed. Risk of this study appears to be low; patients have used TKIís before and will be closely monitored.
- Main changes (audit trail)
- RECORD14-jan-2013 - 2-feb-2013


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