Iressa Re-challenge in Advanced NSCLC EGFR-mutated Patients

NCT02025218 | Terminated Phase 2 DMC

• 1 other identifier: IRENE study - NVALT 16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 14

Brief Summary

To evaluate the effect of re-administration of gefitinib to EGFR-mutated NSCLC patients who had been treated with at least one line of TKIs followed by another line of treatment (non-TKI)

Conditions

Lung Cancer

Keywords

NSCLC; EGFR; TKI; Re-challenge; Lung Cancer; Resistance

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  6 months after last included patient

Study Arms (1)

Re-administration gefitinib

EXPERIMENTAL

Drug: Gefitinib standard dose

Interventions

Gefitinib standard dose DRUG

Re-administration gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.
• WHO / ECOG / Zubrod performance status 0-2.
• Possibility of obtaining tumour material before the start of the study treatment.

You may not qualify if:

• Known severe hypersensitivity to gefitinib or any of the excipients of the product treatment with no persistent radiation toxicity. Previous adjuvant chemotherapy is allowed.
• Progressive disease or stable disease (SD) \<12 weeks as best response to the 1st line treatment with an EGFR-TKI
• Consideration to require radiotherapy to the lung at the time of study entry or in the near future
• 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
• Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
• Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
• Pregnancy or breast-feeding
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
• Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ
• Life expectancy of less than 12 weeks
• Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
• Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
• Previous enrolment or treatment in the present study.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (14)

Ziekenhuis Groep Twente

Almelo, Netherlands

Location

VU University medical Center

Amsterdam, Netherlands

Location

Gelre Ziekenhuis

Apeldoorn, Netherlands

Location

Wilhelmina Ziekenhuis Assen

Assen, Netherlands

Location

Rode Kruis ziekenhuis

Beverwijk, Netherlands

Location

Deventer ziekenhuis

Deventer, Netherlands

Location

Gelderse vallei

Ede, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Martini ziekenhuis

Groningen, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Canisius Wilhelmina ziekenhuis

Nijmegen, Netherlands

Location

Maasstad ziekenhuis

Rotterdam, Netherlands

Location

VieCurie Hospital

Venlo, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

NL (14)