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
Japan	78
Brazil	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

ERLOTINIB HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: April 28, 2026

Erlotinib Hydrochloride: Clinical-Stage Update, Market Position, and Profit-Grade Projections

What is the current clinical development status of erlotinib hydrochloride?

Erlotinib is an established oral EGFR tyrosine kinase inhibitor (TKI). Clinical activity is largely characterized by:

• Regimen optimization in combination settings (EGFR-mutant NSCLC and related EGFR-driven indications)
• Geographic and formulation life-cycle work (new presentations, line extensions)
• Post-approval studies tied to real-world evidence, dosing, and safety characterization

Constraint on “clinical trials update” deliverable: No reliable, complete “as-of-today” trial-by-trial status for all active and enrolling studies can be asserted from the sources available in this environment.

How does erlotinib perform in the oncology market today?

Erlotinib competes in the EGFR TKI segment against:

• First-generation EGFR TKIs: gefitinib (and historically), erlotinib
• Second-generation: afatinib
• Third-generation: osimertinib
• EGFR-focused targeted combinations using newer backbones

Market structure (decision-relevant):

• EGFR mutation testing penetration drives addressable volume.
• Guideline preference increasingly shifts frontline and progression sequences toward third-generation EGFR TKIs in many markets.
• Price erosion and payer channel control matter more than incremental clinical differentiation for an older molecule.

Commercial implication for erlotinib: It remains a volume product in markets and channels where:

• formularies still support it for selected lines and specific patient profiles
• cost and access economics outweigh the relative efficacy gap versus newer agents

What are realistic market projections for erlotinib through the forecast horizon?

A projection requires current baseline sales, by geography and by line of therapy, plus payer coverage and competitive intensity. Those inputs are not available in a way that supports a complete and accurate numeric forecast here.

Constraint on “market analysis and projection” deliverable: A profit-grade projection (revenue, units, and peak/decline curve) cannot be produced without credible baseline sales and forward modeling inputs.

Where does erlotinib sit in the competitive EGFR TKI value chain?

Differentiation that still moves outcomes for buyers is mostly operational:

• Access and reimbursement: payer acceptance is a primary driver
• Switchability: sequencing tolerance in practice
• Clinical fit: continued relevance in subpopulations shaped by EGFR testing patterns and local guideline interpretation

Key competitive pressure points:

• Frontline shift toward osimertinib reduces erlotinib-addressable line-of-therapy volume
• Treatment duration and tolerability expectations have risen with newer TKIs
• Combination strategies can reduce standalone TKI share, depending on local standards of care

Actionable market thesis (non-numeric)

• Demand durability depends on how long payers keep erlotinib in post-first-line or second-line EGFR workflows.
• Downside risk is payer substitution and guideline-driven dislocation in countries with rapid adoption of third-generation EGFR TKIs.
• Upside path exists via targeted clinical positioning in narrowly defined EGFR settings and through continued low-cost access where biomarker and guideline adoption lag.

Key Takeaways

• Erlotinib is an established EGFR TKI with clinical activity that is now mostly post-approval and regimen optimization rather than paradigm-setting discovery.
• Competitive pressure in EGFR NSCLC is structural, driven by guideline preference and sequencing shifts toward newer EGFR TKIs.
• Numeric clinical-trial “update” and revenue/units projections cannot be stated accurately from the available information in this environment.

FAQs

1. Is erlotinib still used in EGFR-mutant NSCLC today?
   Yes, in selected lines and jurisdictions, depending on reimbursement and guideline interpretation.

2. What is the main competitive threat to erlotinib?
   Sequencing displacement as newer EGFR TKIs (especially third-generation) gain frontline and expanded adoption.

3. What drives erlotinib volume?
   EGFR test penetration and payer inclusion across treatment lines.

4. Is erlotinib’s clinical pipeline still active?
   Clinical work continues, but much of it reflects life-cycle and regimen/real-world studies.

5. Can a precise market projection be made without current sales and trial enrollment data?
   No. A credible projection requires a current baseline and forward-looking coverage and competitive inputs.

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References

[1] U.S. Food and Drug Administration. Erlotinib hydrochloride prescribing information.
[2] European Medicines Agency. Tarceva (erlotinib) product information and EPAR documents.
[3] National Library of Medicine. ClinicalTrials.gov (search results for erlotinib).
[4] National Comprehensive Cancer Network (NCCN) Guidelines. Non-Small Cell Lung Cancer (EGFR-directed therapy sections).