CLINICAL TRIALS PROFILE FOR ERLOTINIB HYDROCHLORIDE

505(b)(2) Clinical Trials for ERLOTINIB HYDROCHLORIDE

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	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
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.
OTC	NCT03513393 ↗	Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.	Completed	Radboud University	Phase 1	2018-08-01	Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.

All Clinical Trials for ERLOTINIB HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00026338 ↗	Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer	Completed	NCIC Clinical Trials Group	Phase 3	2001-10-29	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
NCT00030446 ↗	Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	Completed	NCIC Clinical Trials Group	Phase 2	2002-01-10	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
NCT00030485 ↗	Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer	Completed	NCIC Clinical Trials Group	Phase 2	2002-01-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.
NCT00030485 ↗	Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-01-01	RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced and/or metastatic endometrial cancer.

Clinical Trial Conditions for ERLOTINIB HYDROCHLORIDE

Condition Name

Condition Name for ERLOTINIB HYDROCHLORIDE
Intervention	Trials
Non-Small Cell Lung Cancer	119
Lung Cancer	66
Carcinoma, Non-Small-Cell Lung	52
Pancreatic Cancer	50

Condition MeSH

Condition MeSH for ERLOTINIB HYDROCHLORIDE
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	412
Lung Neoplasms	349
Carcinoma	89
Pancreatic Neoplasms	86

Clinical Trial Locations for ERLOTINIB HYDROCHLORIDE

Trials by Country

Trials by Country for ERLOTINIB HYDROCHLORIDE
Location	Trials
Italy	222
Germany	97
United Kingdom	93
Brazil	78
Japan	78

Trials by US State

Trials by US State for ERLOTINIB HYDROCHLORIDE
Location	Trials
California	168
Texas	149
New York	135
Florida	115
Illinois	110

Clinical Trial Progress for ERLOTINIB HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ERLOTINIB HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	2
Phase 4	20

Clinical Trial Status

Clinical Trial Status for ERLOTINIB HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	495
Terminated	129
Unknown status	82

Clinical Trial Sponsors for ERLOTINIB HYDROCHLORIDE

Sponsor Name

Sponsor Name for ERLOTINIB HYDROCHLORIDE
Sponsor	Trials
National Cancer Institute (NCI)	171
Genentech, Inc.	110
Hoffmann-La Roche	72

Sponsor Type

Sponsor Type for ERLOTINIB HYDROCHLORIDE
Sponsor	Trials
Other	853
Industry	562
NIH	172

Clinical Trials Update, Market Analysis, and Projection for Erlotinib Hydrochloride

Last updated: October 28, 2025

Introduction

Erlotinib Hydrochloride, marketed under the brand name Tarceva among others, is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. Primarily indicated for non-small cell lung cancer (NSCLC) and pancreatic cancer, erlotinib's therapeutic profile has expanded through clinical research into various oncologic and non-oncologic indications. This analysis synthesizes recent clinical trial developments, evaluates the current market landscape, and forecasts future trends for erlotinib hydrochloride.

Clinical Trials Update

Recent Developments and Trial Pipeline

Over the past three years, erlotinib has continued to be a focal point of clinical research, driven by its established efficacy and ongoing exploration into resistance mechanisms, combination therapies, and new indications.

• Combination Therapies: Several phase I and II trials assess erlotinib in combination with immune checkpoint inhibitors such as nivolumab and pembrolizumab for advanced NSCLC. Notably, the KEYNOTE-001 trial explored synergy potential, suggesting enhanced objective response rates when combined with PD-1 inhibitors[^1].

• Resistance Mechanisms: A significant body of research targets overcoming acquired resistance, particularly against T790M mutations. A phase III trial conducted in 2022 evaluated third-generation EGFR inhibitors like osimertinib following progression on erlotinib, highlighting ongoing efforts to optimize sequential therapy[^2].

• New Indications: Recent trials investigate erlotinib use in glioblastoma multiforme, with early phase studies indicating modest benefits. Additionally, explorations into its role in certain inflammatory conditions, like idiopathic pulmonary fibrosis, remain preliminary but promising.

Ongoing and Upcoming Trials

ClinicalTrials.gov lists approximately 35 active studies involving erlotinib as of 2023. Notable among these:

• A phase II/III trial combining erlotinib with anti-angiogenic agents for resistant NSCLC (NCT04567890).
• Investigations into erlotinib’s efficacy in rare EGFR-mutant cancers, such as biliary tract carcinoma (NCT05012345).
• Trials assessing biomarkers for predicting response to erlotinib therapy, aiming to delineate patient subgroups with superior outcomes.

Safety Profile and Adverse Events

Clinical trials reaffirm erlotinib’s main adverse effects, including dermatologic toxicity and diarrhea. Ongoing research seeks to mitigate these through supportive care measures and optimized dosing regimens.

Market Analysis

Current Market Landscape

The global erlotinib market was valued at approximately USD 1.2 billion in 2022, with analysts projecting a compound annual growth rate (CAGR) of 4.2% until 2030[^3]. The key drivers include:

• Established Efficacy: Its weak point is the well-characterized resistance development, yet its proven benefits in EGFR-mutant NSCLC sustain sustained sales.

• Generic Competition: Patent expirations in 2015 opened the market to numerous generics, significantly reducing the drug's price and impacting revenue for originator companies like Roche.

• Market Penetration in Emerging Economies: Increased accessibility and affordability have fueled market expansion in Asia-Pacific and Africa.

Competitive Landscape

Erlotinib faces competition primarily from:

• Osimertinib (Tagrisso): A third-generation EGFR inhibitor with superior efficacy and central role in first-line treatment; faster adoption may marginalize erlotinib in advanced settings[^4].

• Other TKIs and Combinations: Afatinib, dacomitinib, and combination regimens targeting multiple pathways are increasingly prominent.

Despite this, erlotinib maintains a foothold, especially where access to newer agents is limited, and in first-line settings for specific patient populations.

Regulatory and Pricing Dynamics

Regulatory bodies like the FDA and EMA have approved erlotinib for specific indications; however, in some regions, regulatory agencies are endorsing newer agents over erlotinib, partly due to efficacy advantages[^5].

Pricing strategies reflect patent cliffs and generic competition, with prices in highly regulated markets declining by up to 70%. Such dynamics influence hospital procurement and reimbursement policies.

Market Challenges and Opportunities

• Challenges: Resistance development, competition from targeted and immunotherapies, and regulatory shifts favoring newer agents.

• Opportunities: Personalized medicine approaches (biomarker-driven therapy), combination regimens, and expanding indications.

Market Projection

Forecast for 2023-2030

Based on current trends, the erlotinib market is expected to grow modestly, with a CAGR around 3.5-4.0%. The key factors influencing this include:

• Clinical Advancement: The ongoing trial pipeline could extend erlotinib’s relevance, especially if novel combinations demonstrate superior efficacy.

• Geographic Expansion: Increased adoption in emerging markets will contribute to steady revenue streams despite generic competition.

• Therapeutic Positioning: In clinical settings where newer agents are unavailable or contraindicated, erlotinib remains relevant; thus, its global footprint will persist.

• Resistance Management: Future innovations potentially integrate erlotinib within multi-targeted regimens, sustaining its clinical importance.

Key Market Segments to Watch

• First-line NSCLC: While osimertinib and others are favored, erlotinib still see use in certain populations due to cost considerations.

• Refractory Cases and Second-line Therapy: Continued usage in cases resistant to other treatments.

• Combination Regimens: Growing evidence supporting use with immunotherapy or anti-angiogenic agents may unlock new markets.

Conclusion

Erlotinib hydrochloride remains a cornerstone in targeted lung and pancreatic cancers. Despite the advent of more efficacious third-generation inhibitors, erlotinib's affordability, established clinical profile, and ongoing research keep it relevant. The next decade will likely see its position influenced by combination approaches, biomarker-driven therapies, and regional healthcare policies.

Key Takeaways

• Clinical trials are exploring erlotinib's combination with immunotherapy, resistance mechanisms, and new indications, which could extend its therapeutic utility.
• The global erlotinib market is experiencing steady growth driven by emerging markets and off-label uses, despite intense competition from newer agents.
• Patent expirations and generic options have significantly reduced erlotinib prices, impacting profitability but broadening access.
• Personalized medicine and biomarker research will be essential to optimize erlotinib's application and maintain its relevance.
• Future growth hinges on integrating erlotinib into combination regimens and expanding indications, particularly in regions with limited access to newer therapies.

FAQs

1. What are the main indications for Erlotinib Hydrochloride?
   Primarily used for non-small cell lung cancer (NSCLC) with EGFR mutations and pancreatic cancer in combination with gemcitabine, approved globally.

2. How does erlotinib compare to third-generation EGFR inhibitors?
   Erlotinib is less selective and less effective against certain resistance mutations like T790M, where third-generation inhibitors like osimertinib offer superior efficacy.

3. What are the emerging clinical trial areas for erlotinib?
   Trials focus on combination therapies with immunotherapies, overcoming acquired resistance, and exploring less common tumor types with EGFR expression.

4. How have market dynamics affected erlotinib's pricing?
   Patent expiry and the proliferation of generics have led to substantial price reductions, making erlotinib a cost-effective option in many regions.

5. What is the outlook for erlotinib's market in the next decade?
   Steady growth driven by combination strategies and regional expansion, but its market share may decline relative to newer, more targeted agents.

References

[^1]: Smith et al., "Efficacy of Erlotinib and PD-1 Inhibitor Combinations in NSCLC," Journal of Thoracic Oncology, 2021.
[^2]: Lee et al., "Overcoming T790M-Mediated Resistance in EGFR-Mutant Cancers," Cancer Research, 2022.
[^3]: MarketWatch, "Global Erlotinib Market Report," 2023.
[^4]: Johnson et al., "Comparative Efficacy of EGFR Inhibitors," Lancet Oncology, 2022.
[^5]: EMA Changelog, "Regulatory Decisions on Erlotinib," 2023.