CLINICAL TRIALS PROFILE FOR XALKORI

All Clinical Trials for XALKORI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00939770 ↗	Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2009-09-21	This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment. Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. (Phase 1 completed 2/15/13)
NCT00939770 ↗	Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma	Completed	Pfizer	Phase 1/Phase 2	2009-09-21	This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment. Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. (Phase 1 completed 2/15/13)
NCT00939770 ↗	Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma	Completed	Children's Oncology Group	Phase 1/Phase 2	2009-09-21	This phase 1/2 trial the studies side effects and best dose of crizotinib and to see how well it works in treating young patients with solid tumors or anaplastic large cell lymphoma that has returned after a period of improvement or does not respond to treatment. Crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. (Phase 1 completed 2/15/13)
NCT01531361 ↗	Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations	Completed	National Cancer Institute (NCI)	Phase 1	2012-02-06	This phase I clinical trial studies vemurafenib with sorafenib tosylate or crizotinib in treating patients with advanced malignancies with BRAF mutations. Sorafenib tosylate and crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of advanced malignancies by blocking blood flow to tumors. Drugs used in chemotherapy, such as vemurafenib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vemurafenib together with sorafenib tosylate or crizotinib may kill more cancer cells.
NCT01531361 ↗	Vemurafenib With Sorafenib Tosylate or Crizotinib in Treating Patients With Advanced Malignancies With BRAF Mutations	Completed	M.D. Anderson Cancer Center	Phase 1	2012-02-06	This phase I clinical trial studies vemurafenib with sorafenib tosylate or crizotinib in treating patients with advanced malignancies with BRAF mutations. Sorafenib tosylate and crizotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of advanced malignancies by blocking blood flow to tumors. Drugs used in chemotherapy, such as vemurafenib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vemurafenib together with sorafenib tosylate or crizotinib may kill more cancer cells.
NCT01548144 ↗	Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer	Terminated	M.D. Anderson Cancer Center	Phase 1	2012-04-01	The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied. Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Pemetrexed is designed to block proteins that may cause tumors to grow. This is an investigational study. Crizotinib is FDA approved and commercially available for the treatment of locally advanced or metastatic non-small cell lung cancer. Pazopanib is FDA approved and commercially available for treatment of advanced renal cell carcinoma. Pemetrexed is FDA approved and commercially available for the treatment of non-small cell lung cancer. The combination of crizotinib with pazopanib, crizotinib with pemetrexed, pazopanib with pemetrexed, and giving all 3 drugs together to patients with advanced cancer is investigational. Up to 364 patients will take part in this study. All will be enrolled at MD Anderson.

Clinical Trial Conditions for XALKORI

Condition Name

Condition Name for XALKORI
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	5
Advanced Malignant Solid Neoplasm	4
Refractory Malignant Solid Neoplasm	4
Non-small Cell Lung Cancer	4

Condition MeSH

Condition MeSH for XALKORI
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	20
Lung Neoplasms	16
Neoplasms	12
Lymphoma	7

Clinical Trial Locations for XALKORI

Trials by Country

Trials by Country for XALKORI
Location	Trials
United States	566
China	69
Japan	36
Canada	29
Italy	28

Trials by US State

Trials by US State for XALKORI
Location	Trials
Texas	21
New York	21
Pennsylvania	19
California	18
Florida	18

Clinical Trial Progress for XALKORI

Clinical Trial Phase

Clinical Trial Phase for XALKORI
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for XALKORI
Clinical Trial Phase	Trials
Recruiting	19
Active, not recruiting	11
Completed	9

Clinical Trial Sponsors for XALKORI

Sponsor Name

Sponsor Name for XALKORI
Sponsor	Trials
Pfizer	23
National Cancer Institute (NCI)	14
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for XALKORI
Sponsor	Trials
Industry	62
Other	43
NIH	14

Xalkori (crizotinib) clinical trials update, market analysis, and exclusivity and patent timeline

Last updated: July 28, 2026

Xalkori (crizotinib) is an FDA-approved ALK and ROS1 inhibitor. The drug is in late-life, with the original brand already past primary regulatory exclusivity and with substantial competitive displacement by next-generation ALK inhibitors across most lines of therapy. Public sources do not support a single, current “clinical trials update” with a defined endpoint cohort structure for Xalkori comparable to active pre-approval pipelines, because the observable trial activity largely concerns historical comparisons, post-marketing studies, and ongoing observational or niche strategy studies rather than late-stage pivotal development.

What clinical trials are still running for Xalkori (crizotinib), and what have the latest results shown?

Short answer: Publicly visible trial activity around Xalkori is largely non-pivotal and concentrated in specific subgroups, real-world cohorts, or sequencing/combination research rather than new phase 3 readouts that would restart a major development cycle.

Which trial phases dominate Xalkori’s current clinical landscape?

• Late-stage pivotal development: largely completed years ago.
• Active or recently updated studies: commonly include phase 1b/2 sequencing experiments, investigator-initiated studies, and post-marketing observational designs.
• Trial endpoints that still appear in recent activity summaries: safety, tolerability, intracranial activity (in ALK+ disease with CNS involvement), and comparative effectiveness versus standard-of-care ALK inhibitors.

What are the most commonly targeted questions in ongoing Xalkori studies?

• Optimal sequencing after or before newer ALK TKIs in ALK-positive non-small cell lung cancer (NSCLC).
• CNS effectiveness and durability in ALK+ and ROS1+ settings.
• Combination tolerability in select regimens where mechanisms may include attempts to improve CNS penetration or overcome resistance.

Where do the latest “actionable” results typically show up?

• Small-cohort publications and conference abstracts rather than phase 3 registrational releases.
• Retrospective analyses tied to real-world practice patterns such as treatment switching and dose modification.

Cited sources do not appear in the prompt context. Without verifiable, up-to-date clinical-trial registry extraction for Xalkori (trial-by-trial status, last update date, and posted results), a precise “clinical trials update” table cannot be produced to Bloomberg-grade standards.

What market does Xalkori still address, and how has demand shifted versus newer ALK inhibitors?

Short answer: Xalkori’s addressable market has contracted because newer ALK inhibitors (including next-generation agents) expanded guideline-preferred first-line and later-line use, especially when CNS activity and response durability are weighed.

What indications drive Xalkori sales historically?

• ALK-positive metastatic NSCLC (first-line and subsequent lines historically).
• ROS1-positive metastatic NSCLC (second-line and beyond historically, depending on approvals and local practice).
• CNS involvement historically mattered because crizotinib has more limited brain penetration than later-generation agents, which changed treatment sequencing over time.

How has standard-of-care changed?

• Next-generation ALK TKIs have increasingly been preferred for ALK-positive disease based on superior response depth and more consistent intracranial activity in head-to-head or comparative evidence sets.
• This shift moves Xalkori into a smaller “option set,” often as:
  • a historical comparator,
  • a later-line agent in selected patients,
  • a bridge in constrained access settings,
  • a rechallenge scenario in resistance-managed disease.

What is Xalkori’s current revenue exposure, and what drives the downside?

Short answer: Xalkori faces structural decline from category displacement and loss of premium brand status, with revenue primarily exposed to:

• continued substitution to newer ALK inhibitors,
• generic or biosimilar-like competitive pressure is unlikely in the classic sense here because crizotinib is a small molecule with generics, but in practice the brand’s share loss and price pressure drive the exposure,
• line-of-therapy compression where newer agents take earlier positions.

Key market risk levers for projections

• Guideline updates that favor next-generation ALK inhibitors in first-line.
• Local payer formularies that lock newer agents as preferred.
• Patient access and drug price benchmarks in oncology.
• Real-world prescribing patterns that reduce use of older TKIs unless contraindications exist.

When does Xalkori lose exclusivity, and what patents control generic entry?

Short answer: The critical “brand exclusivity” is already passed for a marketed oncology small molecule like crizotinib, but the controlling question for generic entry risk is the remaining patent estate for drug substance, formulation, and method-of-use plus any Orange Book-listed patents still in force.

How to map Xalkori’s remaining exclusivity and Orange Book risk

A complete, accurate “loss of exclusivity” and patent-by-patent risk map requires Orange Book listing extraction and patent expiration dates. The prompt does not provide the Orange Book dataset or patent numbers, and no reliable in-scope citation set is available in this conversation. Therefore a precise timeline with numbered patents cannot be produced to a litigable standard.

How strong is the patent estate for Xalkori (crizotinib), and what types of patents matter most?

Short answer: For late-life small-molecule brands, generic launch is usually limited first by:

• listed composition and formulation patents (including salts, polymorphs, dosage forms, and controlled release if claimed),
• method-of-use patents (specific ALK/ROS1 patient populations, dosing regimens, and combination methods),
• any manufacturing-process patents, if still active.

Which patent types most often block or shape generic launch timelines?

• Composition-of-matter: active if any are still listed, less likely at this stage but cannot be asserted without listing data.
• Formulation and dosage form: tablet/capsule composition, excipients, or stability claims.
• Method-of-use: ALK-relevant or ROS1-relevant claims tied to specific clinical criteria or endpoints.
• Combination claims: co-administration with other oncology agents.

What patent litigation affects Xalkori, and what are typical outcomes?

Short answer: Litigation involving late-stage oncology brands usually centers on Paragraph IV challenges to Orange Book-listed patents and settlement agreements that create delayed entry.

A fact-specific account requires:

• case captions,
• filing dates,
• asserted patent numbers,
• court outcomes or settlement dates.

No such litigation dataset is present in the prompt context, so a verified litigation-impact section cannot be generated.

What generic entry risks exist for Xalkori, and what would a launch scenario look like?

Short answer: If any Orange Book-listed patents remain, generic entry risk is determined by which patents are still in force and which are the basis for Paragraph IV filings.

A launch scenario table must include:

• earliest potential generic effective date,
• at-risk period,
• design-around pathways (different crystalline forms, salt forms, formulation changes, different dosing regimens to avoid method-of-use infringement),
• regulatory pathway (ANDA type and any carve-outs).

No Orange Book listing data or ANDA litigation records are provided, so this cannot be produced accurately.

How does Xalkori compare with next-generation ALK inhibitors in clinical positioning and market share outlook?

Short answer: Next-generation ALK TKIs have displaced crizotinib for many patients because they provide more consistent intracranial activity and longer disease control in ALK-positive metastatic NSCLC, shifting Xalkori toward niche or later-line use.

Competitive set to anchor projections

• ALK TKIs commonly used as comparators in ALK+ metastatic NSCLC markets.
• ROS1 TKIs that compete where ROS1 is the primary driver.
• In each geography, payer and guideline differences matter more than molecule-level efficacy in late-life market forecasts.

Market projection framework for Xalkori: what’s most likely over 12 to 36 months?

Short answer: Over the next 12 to 36 months, Xalkori’s most likely trajectory is continued low-growth to decline from:

• remaining guideline-driven substitution to next-generation ALK TKIs,
• increased price competition after brand share erosion,
• shrinking patient pool as first-line selection shifts away from older agents.

Projection drivers that should be quantified in a working model

• Total addressable ALK+ and ROS1+ metastatic NSCLC treated per year (by line).
• Share of prescriptions by line-of-therapy.
• Switching rates after progression (including CNS progression).
• Net price erosion and rebate changes.
• Generic utilization timing.

Why a numerical projection cannot be stated here

A credible projection requires:

• last reported Xalkori sales (brand and net),
• unit and price history by geography,
• payer channel data,
• latest clinical uptake metrics and trial-anchored sequencing changes. No sales or prescribing data is present in the prompt context, so a quantified forecast would be fabricated.

Key Takeaways

• Xalkori’s development cycle is largely late-life; publicly visible activity is not dominated by new pivotal trial outcomes.
• Market opportunity has narrowed as next-generation ALK inhibitors take earlier lines, especially when intracranial activity is a decision driver.
• A patent and exclusivity timeline requires Orange Book listing extraction with patent numbers and expiration dates; litigation requires Paragraph IV case mapping with asserted patents and settlement dates.
• A numeric 12 to 36 month market projection cannot be produced without authenticated sales, share, and prescribing data.

FAQs

1. What is Xalkori’s current FDA label and which ALK or ROS1 patient subgroups remain covered?
2. Has Xalkori’s intracranial efficacy affected sequencing versus newer ALK inhibitors in real-world practice?
3. Which Orange Book patents (composition, formulation, or method-of-use) were last listed for Xalkori and when do they expire?
4. Are there any Paragraph IV challenges for Xalkori that could change generic entry timing?
5. What dosing modifications and safety signals are most cited in current observational studies of crizotinib?

References

1. FDA Orange Book. U.S. FDA Approved Drug Products with Therapeutic Equivalence Evaluations.
2. ClinicalTrials.gov. Search results for crizotinib (Xalkori) trial records and status updates.
3. FDA Drug Label (Xalkori, crizotinib). Prescribing Information.