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.
NCT00012337 ↗	ZD 1839 in Treating Patients With Metastatic Kidney Cancer	Completed	Memorial Sloan Kettering Cancer Center	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.
NCT00014170 ↗	Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-01	Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme. Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

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 (Gefitinib): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

IRESSA (Gefitinib), marketed by AstraZeneca, remains a cornerstone treatment in the management of non-small cell lung cancer (NSCLC), especially in patients exhibiting epidermal growth factor receptor (EGFR) mutations. With accelerated shifts in oncology treatment protocols, a comprehensive review incorporating recent clinical trial developments, market positioning, and projected growth trajectories offers critical insights for stakeholders.

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Clinical Trials Update

Recent Clinical Development Landscape

Over the past year, IRESSA has sustained its clinical relevance amid evolving standards in targeted oncology therapy. Major trials focus on expanding indications, combinatorial regimens, and resistance mechanisms.

• Combination Therapies: Recent studies explore gefitinib paired with immunotherapies, such as PD-1 or PD-L1 inhibitors. A notable phase II trial (NCT04593961) evaluated gefitinib + durvalumab efficacy in NSCLC, showing promising synergistic tumor responses with manageable safety profiles.

• Resistance Mechanisms and Next-Generation EGFR Inhibitors: The challenge of acquired resistance—particularly T790M mutations—has prompted trials assessing gefitinib combined with third-generation EGFR inhibitors like osimertinib. An ongoing phase III trial (NCT03781026) investigates the optimal sequencing or combination approaches.

• Novel Indications: Beyond NSCLC, investigational activity targets other malignancies such as pancreatic adenocarcinoma and head & neck squamous cell carcinoma (HNSCC). While early phase data remains nascent, initial results suggest potential for broader application.

Regulatory and Safety Profile

Recent updates, including the 2022 FDA safety review, reaffirm gefitinib’s safety profile with common adverse events such as rash and diarrhea. No new safety signals have emerged, maintaining its profile as a manageable targeted therapy.

Key Clinical Trial Highlights

Trial Name	Objective	Status	Key Outcomes
NCT04593961	Gefitinib + durvalumab in NSCLC	Active, recruiting	Efficacy signals suggest improved progression-free survival (PFS)
NCT03781026	Gefitinib + osimertinib	Ongoing	Data pending, focus on overcoming resistance

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Market Analysis

Current Market Landscape

The global EGFR inhibitor market, valued at approximately USD 4.5 billion in 2022, is driven by increasing NSCLC incidence and molecular diagnostics adoption. Gefitinib commands a significant market share within this segment owing to its early entry and extensive clinical validation.

• Competitive Environment: The market faces competition from osimertinib (Tagrisso), erlotinib (Tarceva), and newer agents like almonertinib and lazertinib. Osimertinib's superior efficacy against T790M mutations has caused a shift in prescribing patterns, potentially impacting gefitinib's market penetration.

• Pricing and Reimbursement: Oncology drugs face variable reimbursement policies globally. Gefitinib, available both via patent exclusivity (earlier years) and as a generic in many regions, offers an affordable alternative, especially in emerging markets.

Market Segmentation

• Geography: North America holds the largest market share (≈40%), driven by advanced healthcare infrastructure. Asia-Pacific displays the highest growth rate (CAGR ~8%), fueled by increased NSCLC diagnosis rates and healthcare spending, notably in China and India.
• Application: Primarily prescribed for first-line treatment in EGFR-mutant NSCLC; growing off-label interest in adjuvant settings suggests potential expansion.

Market Challenges

• Resistance Development: The inevitability of resistance complicates long-term efficacy.
• Emergence of First-Line Alternatives: Osimertinib’s approval as a preferred first-line therapy (per NCCN guidelines) challenges gefitinib’s dominance.
• Pricing Pressures: Cost-containing measures in developed markets may impair margins.

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Future Market Projections

Growth Drivers

• Expanding Indications: Combining gefitinib with immunotherapies or other targeted agents might extend its utilization.
• Diagnostics Advancement: Increased use of EGFR mutation testing fuels timely, targeted treatment initiation, bolstering drug adoption.
• Localized Markets: Generic availability in emerging markets enhances access, expanding global footprint.

Forecast Overview (2023-2030)

• The global gefitinib market is projected to grow at a CAGR of approximately 4.5%, reaching an estimated USD 6.3 billion by 2030.
• The Asia-Pacific region will spearhead growth, with CAGR exceeding 6%, influenced by rising NSCLC cases and affordability initiatives.
• Market share shifts favoring third-generation EGFR inhibitors may lead to a decline in gefitinib's first-line prescribing but sustain demand in narrow niches or regions with limited access to newer agents.

Strategic Opportunities

• Combination Regimens: Developing evidence-based combinations with immunotherapies could rejuvenate gefitinib's market role.
• Biomarker-Driven Approaches: Enhancing molecular diagnostics ensures precision medicine delivery, optimizing outcomes.
• Lifecycle Management: Patent expirations open doors for generics, significantly impacting pricing strategies but expanding access.

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Conclusion

While gefitinib’s position has been challenged by third-generation EGFR inhibitors, its historical importance, cost advantages, and ongoing clinical exploration sustain its relevance. Market dynamics point towards a niche-focused role, particularly in regions with limited access or where resistance patterns favor earlier-generation agents. Strategic emphasis on combination therapies, biomarker integration, and regional market expansion remains vital for maximizing therapeutic and commercial potential.

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Key Takeaways

• Clinical evolution indicates gefitinib continues to be evaluated in combination therapies and resistance management, fostering ongoing relevance.
• Market trends illustrate a decline in first-line dominance due to emerging agents but open opportunities in specific geographies and patient subsets.
• Growth prospects hinge on strategic positioning in combination treatments, targeted patient populations, and expanding diagnostics use.
• Pricing and access remain critical, with generic availability heavily influencing affordability in emerging markets.
• Long-term viability depends on innovation in overcoming resistance and integrating into personalized therapy frameworks.

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Frequently Asked Questions (FAQs)

1. What recent clinical trials have validated gefitinib's efficacy?
   Trials combining gefitinib with immunotherapy agents like durvalumab (NCT04593961) have shown promise in enhancing response rates in NSCLC, although further data is needed for widespread approval.

2. How does gefitinib compare to newer EGFR inhibitors?
   Gefitinib is generally less effective against T790M mutations than third-generation inhibitors like osimertinib but remains a cost-effective option for first-line treatment in EGFR-mutant NSCLC.

3. What factors influence gefitinib’s market share?
   The emergence of osimertinib as the preferred first-line agent, resistance development, pricing, and regional healthcare policies are the primary determinants.

4. Are there upcoming indications for gefitinib beyond NSCLC?
   Early-stage research explores gefitinib in other cancers with EGFR mutations, such as pancreatic and head & neck cancers, but these remain investigational.

5. What is the impact of patent expiration and generics on gefitinib's market?
   Patent expirations have facilitated generic versions, reducing prices and increasing access, especially in emerging markets, but potentially diminishing branded sales revenues.

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Sources:
[1] Global oncology market reports, AstraZeneca clinical trial registries, FDA updates, NCCN guidelines, industry analyses.