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Last Updated: October 27, 2020

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CLINICAL TRIALS PROFILE FOR GEFITINIB

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505(b)(2) Clinical Trials for Gefitinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT02353741 Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC Recruiting Xinqiao Hospital of Chongqing Phase 2 2015-04-01 This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gefitinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005806 Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer Completed National Cancer Institute (NCI) Phase 1 1999-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00005806 Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer Completed Memorial Sloan Kettering Cancer Center Phase 1 1999-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced non-small cell lung cancer.
NCT00006048 ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer Unknown status AstraZeneca Phase 3 2000-05-01 RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
NCT00006049 ZD 1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer Unknown status AstraZeneca Phase 3 2000-05-01 RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell lung cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gefitinib

Condition Name

Condition Name for Gefitinib
Intervention Trials
Non-small Cell Lung Cancer 55
Lung Cancer 38
Non Small Cell Lung Cancer 23
Breast Cancer 17
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Condition MeSH

Condition MeSH for Gefitinib
Intervention Trials
Carcinoma, Non-Small-Cell Lung 192
Lung Neoplasms 162
Adenocarcinoma 28
Carcinoma 23
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Clinical Trial Locations for Gefitinib

Trials by Country

Trials by Country for Gefitinib
Location Trials
United States 488
China 125
Japan 75
Korea, Republic of 65
Italy 64
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Trials by US State

Trials by US State for Gefitinib
Location Trials
New York 41
Texas 30
California 29
Massachusetts 26
Pennsylvania 22
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Clinical Trial Progress for Gefitinib

Clinical Trial Phase

Clinical Trial Phase for Gefitinib
Clinical Trial Phase Trials
Phase 4 10
Phase 3 51
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Gefitinib
Clinical Trial Phase Trials
Completed 175
Recruiting 56
Unknown status 42
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Clinical Trial Sponsors for Gefitinib

Sponsor Name

Sponsor Name for Gefitinib
Sponsor Trials
AstraZeneca 88
National Cancer Institute (NCI) 65
Sun Yat-sen University 13
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Sponsor Type

Sponsor Type for Gefitinib
Sponsor Trials
Other 380
Industry 182
NIH 68
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