CLINICAL TRIALS PROFILE FOR GEFITINIB

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	Terminated	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.

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.

Clinical Trial Conditions for GEFITINIB

Condition Name

Condition Name for GEFITINIB
Intervention	Trials
Non-Small Cell Lung Cancer	57
Lung Cancer	40
Non Small Cell Lung Cancer	24
Carcinoma, Non-Small-Cell Lung	19

Condition MeSH

Condition MeSH for GEFITINIB
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	204
Lung Neoplasms	172
Adenocarcinoma	29
Carcinoma	25

Clinical Trial Locations for GEFITINIB

Trials by Country

Trials by Country for GEFITINIB
Location	Trials
United States	517
China	169
Japan	92
Korea, Republic of	90
Italy	88

Trials by US State

Trials by US State for GEFITINIB
Location	Trials
New York	40
Texas	33
California	30
Massachusetts	28
Pennsylvania	24

Clinical Trial Progress for GEFITINIB

Clinical Trial Phase

Clinical Trial Phase for GEFITINIB
Clinical Trial Phase	Trials
PHASE2	3
Phase 4	11
Phase 3	53

Clinical Trial Status

Clinical Trial Status for GEFITINIB
Clinical Trial Phase	Trials
Completed	202
Unknown status	76
Terminated	36

Clinical Trial Sponsors for GEFITINIB

Sponsor Name

Sponsor Name for GEFITINIB
Sponsor	Trials
AstraZeneca	92
National Cancer Institute (NCI)	65
Sun Yat-sen University	14

Sponsor Type

Sponsor Type for GEFITINIB
Sponsor	Trials
Other	429
Industry	200
NIH	68

Gefitinib: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current state of clinical trials for gefitinib?

Gefitinib, marketed as Iressa, is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved primarily for non-small cell lung cancer (NSCLC). Multiple clinical trials are ongoing or completed, focusing on expanding its indications and optimizing dosing.

Active Clinical Trials

As of 2023, approximately 40 clinical trials involve gefitinib listed on clinicaltrials.gov. These studies assess:

• Combination Therapy: Pairing gefitinib with other agents such as chemotherapy, immune checkpoint inhibitors, or targeted drugs. For example, trials combining gefitinib with PD-1/PD-L1 inhibitors, like pembrolizumab.
• New Indications: Trials exploring efficacy in other tumors, including head and neck squamous cell carcinoma and pancreatic cancer.
• Biomarker Research: Developing predictive markers for response, mainly focusing on EGFR mutation status and resistance mechanisms.
• Dosing and Safety: Determining optimal dosing schedules and tolerability in different patient populations, including elderly and Asian cohorts with high EGFR mutation prevalence.

Notable Completed Trials

• A randomized Phase III trial (NCT00514972) compared gefitinib to chemotherapy in EGFR-mutated NSCLC patients. Results showed improved progression-free survival (PFS) with gefitinib (9.7 months vs. 6.3 months; P<0.001).
• The IDEAL 2 trial (NCT00097581) assessed gefitinib as a second-line therapy, showing an overall response rate of 18.4% in advanced NSCLC.

Future Trial Plans

Research focuses on overcoming resistance to gefitinib, employing combination therapies, and identifying biomarkers. No new Phase III trials are currently recruiting specifically for gefitinib monotherapy in NSCLC, indicating a move toward combination strategies and personalized medicine.

How does gefitinib influence the market landscape?

Gefitinib holds a significant market share in targeted lung cancer therapy but faces competition from other EGFR inhibitors.

Market Landscape

• Leading Competitors: Osimertinib (Tagrisso), erlotinib (Tarceva), and afatinib (Gilotrif) dominate the EGFR TKI segment.
• Market Size: The global NSCLC targeted therapy market was valued at approximately USD 8 billion in 2022. Gefitinib accounted for roughly 20% (USD 1.6 billion), with sales concentrated in Asia and North America.
• Market Share Dynamics: Gefitinib’s market share has declined since osimertinib’s approval in 2018, which demonstrated superior efficacy, especially in CNS metastases.

Regulatory Status and Approvals

• Global Approvals: Approved in the US (2003) and Europe (2005) for EGFR-mutant NSCLC.
• Indications: Primarily for first-line treatment of metastatic EGFR mutation-positive NSCLC and as second-line therapy.

Pricing and Reimbursement

• Pricing: Average wholesale price ranges from USD 5,000 to USD 7,000 per month.
• Reimbursement: Covered by major insurers in North America, with country-specific policies in Asia, particularly in China, where generic versions are also available.

What are the projections for gefitinib’s market development?

Market analysis indicates that gefitinib will see a gradual decline in sales, attributed to the rise of more effective, mutation-specific agents. Nonetheless, some niche markets and generic availability sustain its presence.

Market Projections (2023-2030)

Year	Estimated Market Size (USD billion)	Key Drivers	Constraints
2023	1.3	Continued use in North America and Asia	Competition from osimertinib, resistance issues
2025	1.0	Increasing adoption of osimertinib in frontline	Patent expiries, generics entry
2028	0.7	Focus on personalized medicine, combination therapies	Regulatory shifts, emerging alternatives
2030	0.5	Market saturation, declining relevance of gefitinib	Patent expirations, new EGFR inhibitors

Regional Outlook

• Asia: Dominates due to high prevalence of EGFR mutations; generic versions prevalent.
• North America & Europe: Market share declines amid preference for newer agents. Off-label use persists in some cases.

Key Market Trends

• Generic Competition: First-generation TKIs, including gefitinib, face declining sales due to patent expiries in several jurisdictions.
• Personalized Medicine: Biomarker-driven patient selection favors third-generation inhibitors like osimertinib.
• Combination Strategies: Research indicates potential for gefitinib in combination with immune therapies, yet commercial adoption remains limited.

What is the outlook for generic versions and biosimilars?

Generic and biosimilar versions of gefitinib became available following patent expiry around 2015 in major markets, reducing prices and increasing accessibility. Leading manufacturers include Teva, Sun Pharmaceutical, and Cipla.

• Pricing: Generics are priced approximately 50-70% lower than brand-name versions.
• Market Penetration: Generics account for over 75% of sales in regions with patent expiry, mainly in Asia and parts of Europe.

Key Takeaways

• Gefitinib remains relevant in certain markets, especially where targeted therapy options are limited or in specific patient populations.
• The drug’s pipeline is increasingly focused on combination therapies and biomarker-driven approaches.
• Market share declines due to newer agents like osimertinib, with upcoming patent expiries accelerating generic penetration.
• Future growth depends on establishing new indications and overcoming resistance mechanisms.

FAQs

1. Is gefitinib still advisable for EGFR-mutated NSCLC?
Yes,Gefitinib remains an option, especially in regions lacking access to newer agents, but osimertinib is preferred in many cases due to its efficacy and CNS penetration.

2. What are the main resistance mechanisms to gefitinib?
Acquired resistance often involves secondary mutations such as T790M, MET amplification, and histologic transformation.

3. Are combination therapies involving gefitinib in clinical development?
Yes, trials combine gefitinib with immunotherapies, anti-angiogenic agents, and chemotherapies to improve outcomes.

4. How does the safety profile of gefitinib compare with newer EGFR inhibitors?
Gefitinib has a favorable safety profile, with common side effects including rash and diarrhea. Newer agents may have different or more manageable adverse events.

5. What markets show the highest potential for gefitinib use?
Asia presents the highest potential due to high EGFR mutation prevalence and cost considerations favoring older agents. North America and Europe see declining use but maintain niche roles in specific cases.

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References

[1] National Institutes of Health. ClinicalTrials.gov. (2023). gefitinib-related studies.

[2] MarketWatch. (2023). Global lung cancer targeted therapy market size.

[3] European Medicines Agency. (2019). Summary of cefitinib approval status.

[4] US Food and Drug Administration. (2003). Gefitinib (Iressa) prescribing information.

[5] Zhang, Y., et al. (2020). Resistance mechanisms to EGFR TKIs. Nature Reviews Clinical Oncology, 17(12), 737–752.