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Completed

NCT Number: NCT01485809

Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy

Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less toxic, compared with previous results, than was chemotherapy in patients with previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority of gefitinib treatment compared to placebo in previously treated patients, a subgroup analysis demonstrated improved survival in particular populations (Asians and non-smokers). The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel versus best supportive care; alternatively, they may just be good prognostic factors. Progression free survival and overall response rate was no statistically significant difference between gefitinib and docetaxel. This suggests gefitinib can provide similar overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients. These studies have demonstrated that gefitinib is effective for the second-line treatment of NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line chemotherapy.

But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic NSCLC patients with squamous cell histology who have failed first-line chemotherapy.

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Key information

Conditions

Squamous Cell Carcinoma of Bronchus

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul Veterans Hospital

Seoul, 134-791, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed locally advanced(stage IIIB or IV) squamous NSCLC
  • Failure of only one first line chemotherapy for advanced disease
  • At least one lesion that unidimensionally measurable by computed tomography (RECIST 1.1)
  • Performance status: ECOG 0-2
  • Age ≥20
  • Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
  • Adequate liver functions
  • : Transaminase (AST/ALT) < 2 X upper normal value
  • Bilirubin < 2 X upper normal value
  • Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 100,000/μL
  • Life expectancy 3 months
  • Written Informed consent prior to any study specific procedures
  • NSCLC with an activating sensitizing EGFR mutation

Exclusion criteria

  • Two or more chemotherapy treatment regimen for advanced disease
  • Previous therapy with other EGFR-TKI related drug
  • Known or suspected brain metastases or spinal cord compression
  • Radiotherapy within 4 weeks before study entry
  • Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
  • Pregnant or lactating women
  • Other serious illness or medical conditions as judged by the investigator
  • Known severe hypersensitivity to gefitinib or any of the excipients of the product
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
  • Presence of EGFR mutation reported to confer resistance to EGFR TKI: exon 20 point mutation (T790M or S768I EGFR) or exon 20 insertion
  • 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,
  • Involvement in the planning and/or conduct of the study

Treatment and study plan

Gefitinib

Drug

Gefitinib 250mg/day, oral daily q every 4 weeks

Other names: Iressa

Primary outcomes

  1. Disease control rate (complete response, partial response, or stable disease) at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. number of participants with adverse events as a measure of safety and tolerability

    Time frame: 2 years

    safety & tolerability: NCI CTCAE version 4.0

Sponsors and collaborators

Lead sponsor

Seoul Veterans Hospital

Other

Registry information

Official study title

A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy

Acronym: SIIS

Important dates

Study start
2011
Primary completion
2011
Study completion
2016
First posted
Dec 6, 2011
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.