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
Florida	18
California	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

Clinical Trials Update, Market Analysis, and Projection for Xalkori (Crizotinib)

Last updated: October 28, 2025

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Introduction

Xalkori (crizotinib), developed and marketed by Pfizer, is a targeted cancer therapy primarily indicated for the treatment of non-small cell lung carcinoma (NSCLC) with specific genetic alterations. Since its approval, Xalkori has transformed the treatment landscape for ROS1-positive and ALK-positive NSCLC patients. This analysis provides a comprehensive update on the latest clinical trials, a detailed market assessment, and future market projections based on current trends and ongoing research.

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Clinical Trials Update

Recent Clinical Developments

Over the past two years, clinical research into Xalkori has primarily focused on expanding its therapeutic indications, optimizing dosing strategies, and combining it with other agents to overcome resistance mechanisms.

1. Expansion to New Indications
   The phase III PROFILE 1014 trial established Xalkori’s efficacy in ALK-positive NSCLC. Subsequently, ongoing trials explore its efficacy in other malignancies with ALK or ROS1 alterations, including inflammatory myofibroblastic tumors (IMT) and certain pediatric cancers.

2. Combination Therapies
   Several trials are assessing Xalkori in combination with boost therapies, such as immune checkpoint inhibitors (e.g., PD-1/PD-L1 blockers), aiming to improve overall response rates and delay resistance. A key study, NCT04551241, evaluates Xalkori plus pembrolizumab in ALK-positive NSCLC.

3. Resistance Mechanisms and Next-Generation Inhibitors
   Data from studies like NCT04476721 indicate ongoing efforts to understand and combat acquired resistance, with focus on next-generation ALK inhibitors such as lorlatinib. Some trials are evaluating sequencing strategies, switching from Xalkori to newer agents upon disease progression.

Ongoing and Completed Trials

• Phase II/III Trials examining the efficacy of Xalkori in ROS1-positive NSCLC with mixed results.
• Investigations into crizotinib's activity in solid tumors beyond NSCLC, including inflammatory conditions and pediatric tumors, continue with promising preliminary data.
• Pharmacokinetic and biomarker studies, such as NCT04997742, assess predictive biomarkers for response and resistance.

Regulatory Status and Approvals

While Xalkori remains FDA-approved for ALK-positive and ROS1-positive NSCLC, regulatory agencies in Europe, Japan, and China have also extended approvals based on expanding clinical data. For instance, in 2022, China's NMPA approved crizotinib for ROS1-positive NSCLC under the brand name Xalkori.

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Market Analysis

Current Market Landscape

Xalkori's global market landscape remains robust, driven by its established role in targeted NSCLC therapy. Key markets include North America, Europe, China, Japan, and emerging markets in Latin America and Asia.

• Market Valuation: As of 2022, the global crizotinib market was valued at approximately $900 million, with Pfizer maintaining a dominant share due to Xalkori’s patent protection.

• Revenue Distribution: North America accounts for nearly 50%, followed by Europe (~25%) and Asia (~20%). Patent expiry in some regions is anticipated within the next 3-5 years, potentially affecting revenue streams.

• Competitive Landscape: The advent of next-generation ALK inhibitors, such as lorlatinib and brigatinib, presents competition. However, Xalkori continues to secure a significant market share due to its early-market entry and clinician familiarity.

Market Drivers

• Increased Diagnosis of Actionable Mutations: Improved diagnostic techniques (next-generation sequencing) have led to better detection of ALK and ROS1 alterations, expanding patient eligibility.

• Expansion of Indications: Ongoing clinical trials could lead to approvals in additional tumor types, broadening market potential.

• Favorable Pricing and Reimbursement Policies: In developed markets, reimbursement schemes bolster sales, complemented by patient assistance programs.

Market Challenges

• Patent Expiry and Generic Entry: Pfizer’s patent expiration in key markets around 2025 could dilute market dominance, encouraging generic versions.

• Emergence of Next-Generation Inhibitors: Drugs like lorlatinib, which demonstrate superior CNS penetration and resistance profiles, threaten Xalkori’s market share.

• Pricing Pressures: Healthcare reform initiatives, especially in Europe and Asia, could lead to price negotiations, impacting revenue.

Future Market Projections

The subsequent five years are critical. The market is projected to grow at a compound annual growth rate (CAGR) of 4-6% from 2023 to 2028, driven by:

• Expansion into new indications (e.g., ROS1-positive and pediatric tumors)
• Technological improvements in molecular diagnostics
• Increase in global NSCLC diagnostic testing

By 2028, the global crizotinib market could surpass $1.3 billion, assuming successful expansion and stabilization of revenue streams despite the impending patent cliff.

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Market Projection: Key Factors Influencing Outlook

Positive Influences

• Enhanced Diagnostic Capabilities: Widespread use of NGS promotes identification of eligible patients, increasing Xalkori demand.
• Regulatory Approvals for New Indications: Evidence supporting use in rare tumors or with combinational therapies can reinforce sales.
• Pipeline and Combination Strategies: Trials exploring Xalkori with immunotherapy or other targeted agents could catalyze new therapeutic paradigms.

Potential Risks

• Patent Expiry & Biosimilar Competition: The entrance of generic competitors around 2025 in major markets threatens to reduce prices and revenue.
• Therapeutic Advances: Next-generation inhibitors demonstrating superior efficacy may replace Xalkori as the first-line standard of care.
• Pricing & Health Policy Shifts: Cost containment policies could restrict access and reimbursement, impacting sales.

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Key Takeaways

• Clinical exploration continues—most notably in combination therapies and in expanding indications beyond NSCLC.
• Market dynamics favor sustained growth in key regions, though patent expiration and competitive threats pose future challenges.
• Innovative strategies, including diagnostic advancements and drug combination trials, are central to maintaining or expanding market share.
• Pfizer’s proactive pursuit of indications and clinical trials bolster the future outlook but require vigilance against emerging competitors and market shifts.
• Long-term projection indicates steady growth, contingent on successful regulatory approvals and strategic positioning against rivals.

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FAQs

1. What are the primary current indications for Xalkori?
Xalkori is approved for ALK-positive and ROS1-positive non-small cell lung carcinoma (NSCLC).

2. How does Xalkori compare to next-generation ALK inhibitors?
While Xalkori was a pioneer in targeted ALK therapy, newer agents like lorlatinib offer improved CNS penetration and resistance profiles, potentially replacing Xalkori as first-line therapy in certain settings.

3. Are there ongoing trials that could expand Xalkori’s indications?
Yes. Trials exploring use in pediatric tumors, inflammatory myofibroblastic tumors, and in combination with immunotherapies are underway.

4. What is the anticipated impact of patent expiry on Xalkori’s market?
Patent expiration around 2025 could introduce biosimilars and generics, likely reducing prices and market share unless Pfizer secures new approvals or indications.

5. How is the diagnostic landscape influencing Xalkori’s market?
Advances in molecular testing, particularly next-generation sequencing, enable more precise identification of eligible patients, expanding the potential target population for Xalkori.

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References

1. Pfizer. (2022). Xalkori (crizotinib) Prescribing Information.
2. National Comprehensive Cancer Network (NCCN). (2023). NCCN Clinical Practice Guidelines in Oncology: NSCLC.
3. Global Market Insights. (2022). Cancer Targeted Therapy Market Analysis.
4. FDA. (2022). Drug Approval and Indication Expansion for Crizotinib.
5. ClinicalTrials.gov. (Accessed 2023). Ongoing trials involving Xalkori.