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

NCT01485809 | Completed Phase 2 DMC

• 1 other identifier: SVH-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of Bronchus

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (1)

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

  2 years

Study Arms (1)

Gefitinib

EXPERIMENTAL

Drug: Gefitinib

Interventions

Gefitinib DRUG

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

Also known as: Iressa

Gefitinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul Veterans Hospital: lead

Study Sites (1)

Seoul Veterans Hospital

Seoul, 134-791, South Korea

Location

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bong-Seog Kim, M.D

  Seoul Veterans Hospital

  PRINCIPAL INVESTIGATOR

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: Principal investigator

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 6, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2016
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

KR (1)