CLINICAL TRIALS PROFILE FOR TAGRISSO

All Clinical Trials for Tagrisso

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02465060 ↗	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Recruiting	National Cancer Institute (NCI)	Phase 2	2015-08-12	This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
NCT02496663 ↗	Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2016-03-24	This phase I trial studies the side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a better treatment for EGFR-mutant non-small cell lung cancer.
NCT02503722 ↗	Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2016-10-13	This phase I trial studies the side effects and best dose of sapanisertib when given together with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02520778 ↗	Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2016-03-31	This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body (metastatic) or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT02736513 ↗	Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases	Active, not recruiting	Rabin Medical Center	Phase 2	2016-05-01	Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.
NCT02736513 ↗	Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases	Active, not recruiting	Soroka University Medical Center	Phase 2	2016-05-01	Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.
NCT02759835 ↗	Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2016-04-13	Background: Some non-small-cell lung cancers (NSCLC) have a mutation in a gene that makes a protein called EGFR. This particular cancer can be treated with certain drugs such as Erlotinib (Tarceva), Gefitinib (Iressa) and Osimertinib (Tagrisso). But many tumors become resistant to these drugs because of a second mutation. Researchers want to test if adding local ablative therapy (LAT) extends the benefits of the drug, Osimertinib. LAT can include techniques such as surgery, radiofrequency ablation, cryotherapy or radiation therapy. Objective: To test if re-taking osimertinib after LAT is safe, tolerable, and effective for people whose NSCLC has progressed after initial treatment with osimertinib. Eligibility: Adults ages 18 and older with certain types of NSCLC. Participants will be divided into various groups as described below. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Tumor scans Eye exam Review of tumor sample. Participants will take the study drug by mouth once a day. They will continue until they can no longer tolerate it or their disease worsens. They will keep a dosage diary. All participants will start each 21-day course with physical exam; blood, urine, and saliva tests; and electrocardiogram. They will have scans every 6 weeks and echocardiogram every 3 months. Groups 1 and 2 will: Start osimertinib right away. Have LAT if their disease gets worse and is suitable for LAT. If LAT cannot be performed or LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Re-start osimertinib after LAT, or other treatments if not suitable for LAT. Group 3 will: Have LAT. If LAT consists of a procedure other than surgery, a tumor biopsy will be performed. Start osimertinib after LAT. After participants stop taking the drugs, they will have a final visit. This will include: Medical history Physical exam Heart and blood tests Participants will be called every year for follow-up.

Clinical Trial Conditions for Tagrisso

Condition Name

Condition Name for Tagrisso
Intervention	Trials
Stage IV Lung Cancer AJCC v8	11
Stage IVA Lung Cancer AJCC v8	10
Stage IVB Lung Cancer AJCC v8	10
Non-small Cell Lung Cancer	10

Condition MeSH

Condition MeSH for Tagrisso
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	54
Lung Neoplasms	42
Carcinoma	19
Neoplasms	7

Clinical Trial Locations for Tagrisso

Trials by Country

Trials by Country for Tagrisso
Location	Trials
United States	266
China	29
Italy	21
Korea, Republic of	20
France	15

Trials by US State

Trials by US State for Tagrisso
Location	Trials
California	23
Texas	14
Massachusetts	13
Ohio	12
Florida	11

Clinical Trial Progress for Tagrisso

Clinical Trial Phase

Clinical Trial Phase for Tagrisso
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	6
Phase 2	32

Clinical Trial Status

Clinical Trial Status for Tagrisso
Clinical Trial Phase	Trials
Recruiting	31
Not yet recruiting	20
Active, not recruiting	15

Clinical Trial Sponsors for Tagrisso

Sponsor Name

Sponsor Name for Tagrisso
Sponsor	Trials
National Cancer Institute (NCI)	19
AstraZeneca	17
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for Tagrisso
Sponsor	Trials
Other	53
Industry	41
NIH	19

TAGRISSO (osimertinib) clinical trials update, market analysis, and sales projection

Last updated: May 20, 2026

TAGRISSO (osimertinib) is an established third-generation EGFR TKI with expanding lifecycle assets across earlier-line, adjuvant, and combination settings, plus new biomarker-led studies. Commercially, the drug’s revenue outlook depends on (1) sustaining uptake in metastatic EGFR-mutant NSCLC, (2) conversion of adjuvant and perioperative demand where results support practice change, and (3) competitive pressure from other EGFR inhibitors and emerging sequencing strategies.

What is the latest clinical trials update for TAGRISSO (osimertinib)?

The TAGRISSO development program centers on EGFR-mutant NSCLC across treatment lines, including adjuvant/perioperative strategies, earlier-line metastatic therapy, and combinations designed to improve depth and duration of response.

Which TAGRISSO trials are shaping near-term clinical practice?

Adjuvant / early-stage

• Ongoing and completed studies evaluating osimertinib after resection in EGFR-mutant NSCLC, with the main decision points tied to disease-free survival and updated event-driven analyses.
• Perioperative and adjuvant strategies remain the key driver category for addressable market expansion beyond metastatic disease.

Metastatic EGFR-mutant NSCLC

• Earlier-line randomized evaluations versus standard-of-care EGFR TKIs are the main battleground for retaining and increasing first-line share.
• Combo studies for resistance management and depth-of-response improvements are the pipeline segment most likely to create additional line-of-therapy conversions.

Biomarker-defined cohorts

• Trials in uncommon EGFR mutations and resistance-defined subgroups target label expansion and sequencing differentiation.
• Biomarker stratification is used to align efficacy with prior EGFR inhibitor exposure.

What endpoints and signals matter most in osimertinib trials right now?

• Overall survival where mature data are available
• Disease-free survival for adjuvant/perioperative programs
• Objective response rate and duration of response for combination studies
• Safety/tolerability profiles that affect real-world adherence and discontinuation rates

How do trial populations differ across TAGRISSO studies?

• Treatment-line differences drive distinct adoption curves: newly diagnosed metastatic settings typically ramp faster than adjuvant, which follows post-surgical identification workflows.
• Prior EGFR TKI exposure changes resistance biology and can shift expected benefit distributions, impacting sequencing recommendations.

How big is the TAGRISSO market, and what is the current revenue base?

TAGRISSO is among the top-selling oncology small molecules for solid tumors, with revenue driven by:

• EGFR-mutant NSCLC prevalence in clinically tested populations
• Treatment line migration (earlier initiation vs later use)
• Geography and reimbursement environment
• Real-world testing rates and guideline adherence for biomarker screening

Where does TAGRISSO revenue come from by setting?

• Metastatic first-line EGFR-mutant NSCLC is typically the largest contributor, supported by guideline integration and payer coverage.
• Adjuvant/perioperative segments provide the most credible medium-term growth vector if post-surgical adoption continues to scale.
• Later-line use depends on sequencing and the competitive landscape of post-progression EGFR strategies.

What market share risks exist for osimertinib?

• Competition from other EGFR inhibitors with favorable efficacy and toxicity profiles
• Sequencing shifts prompted by evolving standard-of-care
• Price pressure via tendering, payer restrictions, and health-technology assessment outcomes
• Safety constraints and dose modifications affecting persistence

When does TAGRISSO lose exclusivity, and what does that mean for generic entry risk?

The commercial trajectory is strongly influenced by exclusivity windows and patent enforcement posture in the US and key markets.

What patent and exclusivity events govern TAGRISSO timing?

• US regulatory exclusivity and patent expirations (including relevant formulation, use, and method claims) determine Paragraph IV dynamics.
• EU/UK and other jurisdictions add parallel expiry and litigation timelines that can delay generics and biosimilar-like entrants for small molecules via follow-on processes and patent challenges.

What is the Orange Book status of TAGRISSO?

TAGRISSO’s US exclusivity and patent listing status is assessed through the Orange Book for:

• Drug substances and drug products
• Expiration dates by listed patent
• Any exclusivity-labeled events that constrain generic approval pathways

How many patents protect TAGRISSO, and how strong is the patent estate?

A TAGRISSO patent estate typically includes layered IP covering:

• Active ingredient composition and crystalline/solid-state forms
• Formulations and dosing regimens
• Methods of use tied to EGFR-mutant subsets and treatment settings
• Manufacturing methods and intermediate compounds

Which claim categories tend to matter most in litigation?

• Method-of-use patents tied to specific patient subpopulations and clinical endpoints can be harder for generics to design around without waivers or carve-outs.
• Formulation/solid-state claims can block generic substitution when they are not bioequivalent by design.

How is TAGRISSO’s IP likely to affect generic launch scenarios?

• If key method-of-use claims remain in force at filing time, Paragraph IV applicants face higher risk of injunction exposure.
• Settlement agreements, if any, can produce delayed entry dates aligned with last-to-expire patents or stipulated launch carve-outs.

What patent litigation affects TAGRISSO, including Paragraph IV challenges and settlements?

Generic risk depends on:

• The presence of listed patents with plausible validity and enforceability challenges
• The number of defendants and asserted patents in each wave
• Whether courts grant injunctions or whether parties settle for delayed launch terms

How do Paragraph IV filings change generic entry timing?

• Patent challenges can trigger 30-month stays depending on litigation status and first-filer provisions.
• Settlements typically reduce the probability of a trial-driven injunction and move the market to contract-driven launch schedules.

What outcomes are most likely to protect TAGRISSO sales?

• Consent judgments or stipulated dismissals tied to entry delays
• Sustained enforcement of core method-of-use or formulation claims
• Regulatory delays from labeling negotiations or product design constraints

What formulations are protected for TAGRISSO, and how could that affect bioequivalence?

TAGRISSO is marketed as an oral tablet. The formulation IP landscape can include:

• Tablet composition and excipient systems
• Solid-state properties and polymorph definitions
• Manufacturing conditions and process controls

Which formulation patent types most often block generic substitutes?

• Solid form and crystallinity claims
• Tablet composition claims with specific ranges
• Process claims that constrain reproducibility of critical solid-state attributes

How does TAGRISSO compare with competing EGFR therapies in efficacy, safety, and adoption?

TAGRISSO competes across EGFR-mutant NSCLC with:

• Other EGFR TKIs used in first-line and post-progression settings
• Combination regimens in earlier-stage and metastatic settings that change sequencing behavior

What factors drive physician and payer preference for osimertinib?

• Depth and durability of response in EGFR-mutant cohorts
• Central nervous system activity relevant to metastatic disease profiles
• Safety profile that supports longer treatment durations
• Label breadth across mutation types and prior exposure states

Where does competition most pressure TAGRISSO?

• Regions with aggressive tendering and cost-effectiveness thresholds
• Patient populations where alternative EGFR TKIs show comparable outcomes
• Sequencing strategies that prioritize newer combinations

What does the pipeline for TAGRISSO look like, and what is the probability of value inflection?

Value inflection comes from:

• Positive event-driven readouts in adjuvant/perioperative and combination studies
• Biomarker expansions that broaden addressable populations
• Treatment regimen simplification that increases adoption and persistence

What clinical areas could extend TAGRISSO’s revenue runway?

• Earlier-stage EGFR-mutant NSCLC adoption if confirmatory endpoints remain positive
• Post-progression strategies that restore or improve long-term disease control
• Combination approaches that address resistance biology without unacceptable toxicity

What market projections are most relevant for TAGRISSO sales growth?

Projections for TAGRISSO should be modeled around:

• Patient pool growth from expanded biomarker testing and guideline compliance
• Conversion rates from metastatic to earlier-line adoption
• Adjuvant uptake after surgical identification and payer coverage decisions
• Competitive share shifts from alternative EGFR inhibitors and combination therapies

Sales drivers and constraints

• Drivers: EGFR-mutant incidence in tested populations, adoption of earlier-line and adjuvant use, persistence based on tolerability.
• Constraints: pricing pressure, payer restrictions, safety-related discontinuations, and competitive offerings.

Projected outlook framework (industry-standard)

A robust projection structure typically uses:

• TAM: EGFR-mutant NSCLC treated in eligible settings
• SAM: guideline-supported and reimbursed segments
• SOM: share influenced by efficacy, safety, and formulary access
• Time: forecast horizon until key exclusivity and major pipeline milestones

Key Takeaways

• TAGRISSO’s near- and mid-term growth depends on adoption in earlier settings (adjuvant/perioperative) and sustained first-line share in metastatic EGFR-mutant NSCLC.
• The biggest commercial risks are payer-driven pricing pressure, competitive sequencing changes, and patent/litigation outcomes that could accelerate generic entry.
• The highest value inflection points are event-driven trial readouts that support practice changes in earlier-stage disease and biomarker expansions.

FAQs

1. What are the most important TAGRISSO clinical endpoints to watch for adjuvant EGFR-mutant NSCLC?
2. How do Paragraph IV challenges typically impact osimertinib launch timing in the US?
3. Which EGFR mutation subgroups are most likely to expand TAGRISSO label coverage?
4. How does TAGRISSO compare with other EGFR TKIs in CNS activity and durability of response?
5. What market factors most influence TAGRISSO uptake in payer-restricted formularies?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).
2. ClinicalTrials.gov. TAGRISSO (osimertinib) studies. (Accessed via ClinicalTrials.gov).
3. EMA. European public assessment reports and EPAR/SmPC documents for Tagrisso (osimertinib). (Accessed via EMA).