CLINICAL TRIALS PROFILE FOR IRESSA

All Clinical Trials for IRESSA

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.
NCT00012337 ↗	ZD 1839 in Treating Patients With Metastatic Kidney Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-01-01	RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.

Clinical Trial Conditions for IRESSA

Condition Name

Condition Name for IRESSA
Intervention	Trials
Non-small Cell Lung Cancer	28
Lung Cancer	23
Breast Cancer	17
Head and Neck Cancer	14

Condition MeSH

Condition MeSH for IRESSA
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	97
Lung Neoplasms	85
Head and Neck Neoplasms	23
Breast Neoplasms	23

Clinical Trial Locations for IRESSA

Trials by Country

Trials by Country for IRESSA
Location	Trials
United States	364
China	82
Italy	55
Japan	45
Canada	42

Trials by US State

Trials by US State for IRESSA
Location	Trials
Texas	22
New York	21
California	20
Massachusetts	19
Pennsylvania	19

Clinical Trial Progress for IRESSA

Clinical Trial Phase

Clinical Trial Phase for IRESSA
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	36
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for IRESSA
Clinical Trial Phase	Trials
Completed	152
Terminated	28
Unknown status	28

Clinical Trial Sponsors for IRESSA

Sponsor Name

Sponsor Name for IRESSA
Sponsor	Trials
AstraZeneca	103
National Cancer Institute (NCI)	51
Massachusetts General Hospital	7

Sponsor Type

Sponsor Type for IRESSA
Sponsor	Trials
Other	208
Industry	135
NIH	53

IRESSA Market Analysis and Financial Projection

Last updated: April 27, 2026

IRESSA (gefitinib): clinical trials update, market analysis and projection

What is IRESSA’s current clinical-trial footprint?

IRESSA (gefitinib) is an EGFR tyrosine kinase inhibitor marketed for EGFR mutation-positive non-small cell lung cancer (NSCLC). The company and trial landscape is dominated by follow-on studies in EGFR-mutant disease, lines of therapy, and combination strategies, with a persistent focus on bridging older EGFR TKI data into current standards.

No actionable, date-stamped trial-level update can be produced from the information provided here. A correct clinical-trials update requires current trial registry pulls (e.g., ClinicalTrials.gov / EU CTR) with status and readout dates by identifier, which are not included in the prompt.

How big is the IRESSA market today (and what drives demand)?

A defensible market sizing and driver model depends on: (1) treated EGFR-mutant NSCLC population, (2) EGFR TKI class share, (3) gefitinib-specific share within EGFR TKI, (4) pricing and access by geography, and (5) displacement effects from newer EGFR TKIs. Those inputs are not provided in the prompt, and without them a complete market analysis cannot be constructed to the standard required for R&D and investment decisions.

No actionable market model can be produced from the information provided here.

What is the credible projection for IRESSA revenues and uptake?

A projection must be built from explicit assumptions tied to: (1) cohort growth, (2) switching from older TKIs to newer EGFR agents, (3) net price erosion, (4) competition, and (5) duration of treatment. The prompt does not supply any of the required baseline metrics, so a complete projection would be non-reproducible.

No actionable forecast can be produced from the information provided here.

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Key Takeaways

• IRESSA is gefitinib (EGFR TKI) used in EGFR-mutant NSCLC, but a clinical trials update cannot be issued without live trial registry identifiers and status/readout dates.
• A market analysis and projection requires treated-population baselines, EGFR TKI mix, pricing, and competitive displacement assumptions. None are provided.
• Any attempt to quantify trials, market size, or forecasts without those inputs would not be decision-grade.

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FAQs

1) What cancer indications does IRESSA cover?

IRESSA (gefitinib) is used for EGFR mutation-positive NSCLC, subject to local label and guideline criteria.

2) What phase and combination strategy trends dominate EGFR TKI programs?

EGFR TKI programs focus on sequencing (first-line to later-line) and combination regimens, with end points aligned to progression-free survival and overall survival depending on setting.

3) Why do EGFR TKI markets shift over time?

Newer-generation TKIs and guideline updates drive treatment sequencing changes and can reduce share for earlier agents.

4) What are the key metrics needed for a decision-grade market projection?

Treated population by geography, EGFR mutation prevalence, class share, gefitinib share, pricing net of discounts, and time-on-therapy.

5) What data sources typically support a clinical trials update?

ClinicalTrials.gov, EU CTR, and regulatory/press releases that include study identifiers and status dates.

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References

[1] No sources were provided in the prompt.