RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC30H35ClN4O2

InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N

CAS Registry1256589-74-8

Clinical Trials associated with Alectinib Hydrochloride

ChiCTR2600125803

/ Not yet recruitingNot ApplicableIIT

A Prospective, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Alectinib in Conversion Surgery for Locally Advanced ALK Fusion-Positive NSCLC

Start Date01 Jun 2026

Sponsor / Collaborator-

NCT07560410

/ Not yet recruitingPhase 1/2IIT

Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Eligible patients must have disease progression after standard therapy or no suitable standard treatment options.
Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators. The study aims to assess antitumor activity, safety, and clinical outcomes in this rare molecular subtype of bone cancer.

Start Date15 May 2026

Sponsor / Collaborator

China Medical University Hospital

NCT05987956

/ Active, not recruitingPhase 2/3

Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Start Date18 Mar 2026

Sponsor / Collaborator

Medicine Invention Design, Inc.

[+1]

100 Clinical Results associated with Alectinib Hydrochloride

100 Translational Medicine associated with Alectinib Hydrochloride

100 Patents (Medical) associated with Alectinib Hydrochloride

1,555

Literatures (Medical) associated with Alectinib Hydrochloride

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of lorlatinib as first-line treatment for anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer in Italy

Article

Author: Pasello, Giulia ; Novelli, Giuseppe ; Rumi, Filippo ; Di Virgilio, Roberto ; Bearz, Alessandra ; Basile, Michele ; Di Brino, Eugenio ; Valentini, Ilaria

BACKGROUND:

Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) with high central nervous system penetration and activity against resistance mutations. Although its clinical efficacy as first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC) has been demonstrated, its economic value within the Italian healthcare system remains to be fully established. This study evaluated the cost-effectiveness of lorlatinib compared with alectinib as first-line therapy in Italy.

METHODS:

A partitioned survival model with three health states (progression-free, progressed disease, and death) was developed from the Italian National Health Service and societal perspectives over a 30-year time horizon. Clinical efficacy inputs were derived from the CROWN trial and indirect treatment comparisons using network meta-analysis. Costs (2026 euros) included drug acquisition, subsequent treatments, healthcare resource use, adverse events, end-of-life care, and societal costs. Health outcomes were expressed as life-years (LYs) and quality-adjusted life-years (QALYs). Deterministic, probabilistic, and scenario analyses were conducted to assess uncertainty.

RESULTS:

In the base case, lorlatinib was dominant over alectinib, providing higher benefits (+2.01 LYs; +1.66 QALYs) at lower costs (-€19,210 per patient). This finding was robust across pricing scenarios. Probabilistic sensitivity analysis showed an almost 98,40% probability of cost-effectiveness at Italian willingness-to-pay thresholds.

CONCLUSIONS:

From both NHS and societal perspectives, lorlatinib represents a cost-saving and clinically superior first-line treatment option compared with alectinib for patients with ALK-positive advanced NSCLC in Italy.

31 Dec 2026·Lung Cancer Management

Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China

Article

Author: Zhu, Fanfan ; Li, Hongchao ; Xue, Jing ; Le, Hannah ; Duan, Jia ; Hu, Bingqi ; Li, Dingsiman ; Rifi, Nada ; Dong, Peng ; Luan, Luan

AIM:

To estimate brain metastases (BM) management costs in Chinese ALK+ advanced non-small-cell lung cancer (NSCLC) patients receiving first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).

METHODS:

A survey of 105 clinical experts across 23 Chinese regions evaluated healthcare resource utilization (HCRU). Total annual costs with TKIs were calculated by weighting the management costs of patients with and without BM using the cumulative incidence rate (CIR) of BM from ALK-TKI clinical trials.

RESULTS:

First-year management cost averaged ¥24,974 per-patient without BM versus ¥89,859 per-patient with BM, saving ¥64,885. Subsequent years saved ¥33,231. Applying 12-month CIR of BM, the annual costs per-patient were ¥26,791 for 1 L lorlatinib versus ¥46,516 for crizotinib in the intention-to-treat (ITT) population. Subgroup analysis showed annual costs of ¥25,623 per-patient with lorlatinib in those without BM and ¥29,775 in those with BM. Alectinib's and brigatinib's costs were ¥31,073 and ¥32,760 respectively, using the 12-month CIR of BM. Lorlatinib's cost savings increased progressively over 1-4 years. Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials.

CONCLUSION:

Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.

01 Jul 2026·Translational Oncology

Molecular profiling and personalized medicine within EURACAN in the SPECTA Arcagen study in comparison to the France Genomic Medicine 2025 Plan in the AURAGEN platform in peritoneal mesotheliomas

Article

Author: Kepenekian, Vahan ; Momenkhan, Seddig ; Tejpar, Sabine ; Fontaine, Juliette ; Villeneuve, Laurent ; Morfouace, Marie ; Isaac, Sylvie ; Blay, Jean-Yves ; Benzerdjeb, Nazim ; Oliveira, Julio ; Glehen, Olivier ; Péron, Julien

Peritoneal mesothelioma (PM) is a rare aggressive cancer with limited therapeutic options upon progression. Two genomic profiling initiatives were launched to implement personalized medicine in rare cancers: the EURACAN molecular profiling and personalized medicine pathway and the France Genomic Medicine 2025 plan (AURAGEN). The aim of this study was to describe initial findings in PM and to compare these approaches in a real-world implementation setting. Herein, we present the results from a cohort of 56 patients with PM. Females represented 55.4% of patients; mean age was 55.9 years. The European (Arcagen) study profiled 26 patients and the AURAGEN platform profiled 42 patients. Genomic sequencing was performed using Foundation Medicine for the Arcagen cohort and whole-genome sequencing (WGS) for the AURAGEN cohort. Arcagen used FFPE tissue or blood depending on material availability, whereas AURAGEN relied on fresh frozen tumor tissue with paired blood (and RNA sequencing when feasible). Both cohorts displayed a predominance of alterations in BAP1, NF2, and CDKN2A/B. One patient with an ALK::STRN fusion was treated with Alectinib. AURAGEN identified a larger number of altered genes overall, while the proportion of therapeutic targets was similar between approaches. In conclusion, comprehensive molecular profiling offers potential therapeutic strategies for PM patients. Panel-based profiling and pan-genomic WGS appear complementary in real-world practice, each with distinct strengths and limitations.

163

News (Medical) associated with Alectinib Hydrochloride

10 Jun 2026

·www.einpresswire.com

Three Reputable Pharmaceutical Intermediate Manufacturers in China 2026: Powering Global Drug Development

Highlighting advanced manufacturing capabilities, stringent quality standards, and reliable supply for pharmaceutical innovation worldwide. CALIFORNIA, CA, UNITED STATES, June 10, 2026 / EINPresswire.com / -- SHANDONG, China — As global demand for cost-effective and high-quality pharmaceutical intermediates intensifies, three Chinese manufacturers have emerged as key players in supplying the building blocks for active pharmaceutical ingredients (APIs) used in anti-cancer, antiviral, and chronic disease therapies. Haohong (Qihe) Pharmaceutical Technology Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., and CSPC Pharmaceutical Group Limited represent distinct segments of the market, each offering specialized capabilities that power drug development pipelines worldwide. Industry Context The pharmaceutical intermediate market, estimated at over $40 billion globally in 2025, is projected to grow at a compound annual growth rate of 6-7% through 2030, driven by increasing R&D investments in targeted therapies and generic drug manufacturing. Chinese manufacturers collectively account for more than 30% of global intermediate supply, leveraging integrated chemical synthesis capabilities and cost advantages. Within this landscape, companies differentiate themselves through purity standards, batch consistency, regulatory compliance, and customized synthesis services. Company Profiles and Competitive Strengths Haohong (Qihe) Pharmaceutical Technology Co., Ltd., established in 2021 and based in Shandong Province, specializes in high-grade active pharmaceutical intermediates and custom synthesis. The company employs approximately 75 staff and operates a 3,000-square-meter manufacturing facility with an annual production capacity of 1,000 tons. Export business accounts for 40% of total sales, with products reaching the United States, Europe, Japan, India, and Bangladesh. Haohong holds ISO 9001:2015 certification and was recognized as a Technology-based Small and Medium-sized Enterprise in 2024 and awarded Innovative Small and Medium-sized Enterprise of Shandong Province in 2025. Its research and development team comprises 30 engineers, supporting custom synthesis from gram scale to hundreds of kilograms. The production base in Liaocheng is equipped with 30 sets of 3,000–5,000L reactors. The company focuses on anti-cancer, anti-hepatitis C, and anti-diabetic intermediates, including key products for Apalutamide, Abemaciclib, and Alectinib. Haohong’s competitive edge lies in its ability to deliver ultra-high purity (≥98%) with strict impurity control and batch-to-batch consistency, supported by complete technical documentation compliant with ICH and GMP standards. The company also holds multiple utility model patents for production equipment, including a waste gas absorption device and a gas chromatography detection system. Zhejiang Huahai Pharmaceutical Co., Ltd. (SZSE: 600521), founded in 1998 and headquartered in Linhai, Zhejiang, is one of China’s largest API and intermediate manufacturers. Huahai specializes in cardiovascular, central nervous system, and anti-cancer drugs. It operates multiple FDA- and EMA-approved facilities and exports to over 50 countries. Huahai’s strength lies in its vertically integrated supply chain, extensive regulatory dossier library (more than 100 ANDAs), and large-scale production capacity exceeding 5,000 tons per year for certain intermediates. The company has a robust R&D pipeline and is a preferred partner for branded generic drug manufacturers in the United States and Europe. Huahai’s market capitalization exceeds $3 billion, reflecting its established position. CSPC Pharmaceutical Group Limited (HKEx: 1093), founded in 1938 and headquartered in Shijiazhuang, Hebei, is a leading Chinese pharmaceutical conglomerate with a strong presence in innovative drug development and bulk intermediates. With over 20,000 employees and annual revenue exceeding $4 billion, CSPC manufactures a wide range of chemical intermediates, APIs, and finished formulations. The company has a dedicated oncology intermediate division, producing key precursors for drugs like lenvatinib and olaparib. CSPC differentiates itself through its proprietary continuous flow chemistry technology and its ability to scale from laboratory to commercial production rapidly. The group holds multiple patents on synthesis routes and is a major supplier to multinational pharmaceutical companies for clinical trial materials. Comparative Advantages While Huahai and CSPC dominate in scale, regulatory approvals, and global brand recognition, Haohong positions itself as a specialized, high-agility partner for customers requiring high-purity custom intermediates, particularly in the oncology and targeted therapy space. Haohong’s strengths include timely delivery, stable batch quality, comprehensive technical documentation, and a flexible approach to custom synthesis—from gram-scale R&D batches to metric ton-level commercial supply. According to internal comparison data, Haohong’s product purity is on average 0.02% higher than industry peers, and batch quality stability is 10% above the industry average. The company’s self-owned factory and deep R&D capabilities allow it to offer competitive pricing without compromising quality. Market Impact and Analyst Perspective The diversification of intermediate suppliers is critical for global drug developers seeking supply chain resilience. “Companies like Haohong fill a niche for project-specific, high-purity intermediates that require close collaboration and rapid turnaround,” said a pharmaceutical supply chain analyst based in Shanghai. “While large players offer volume, smaller specialized manufacturers often provide better customization and faster response times.” The trend toward more complex targeted therapies, such as antibody-drug conjugates and protein degraders, demands higher purity intermediates with controlled chiral and steric properties—areas where dedicated Chinese manufacturers are investing heavily. Outlook As the global pharmaceutical industry continues to outsource intermediate production, the three companies highlighted are expected to capture growing demand. Haohong plans to expand its reactor capacity and pursue additional industry certifications. Huahai is investing in continuous manufacturing platforms. CSPC is accelerating its innovative drug pipeline, which in turn drives demand for proprietary intermediates. The competitive landscape in China remains fragmented, but specialized players with strong technical foundations and international traceability are well-positioned for growth. For more information about Haohong Pharmaceutical ’s product range and capabilities, download the company brochure: Haohong Corporate Brochure Contact: Xu Tianxia | Email: Xutx@haohong-pharma.com | Tel: +86 180-6854-1569 Address: Block B, building 3, accelerator, high tech Zone, Qihe County, De Zhou City, Shandong Province, China Website: www.haohong-pharma.com Xu Tianxia Haohong (Qihe) Pharmaceutical Technology Co., Ltd + +86 180-6854-1569 Xutx@haohong-pharma.com Visit us on social media: Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

09 Jun 2026

·www.fiercebiotech.com

GSK inks $10.6B Nuvalent buyout to challenge Roche and Pfizer in lung cancer

GSK CEO Luke Miels said the deal “will strengthen our operating profit ... through the dolutegravir loss of exclusivity period.”\n GSK has struck a deal to buy Nuvalent for $10.6 billion, securing two near-approval cancer therapies that could challenge products from Roche, Pfizer and other drugmakers. The FDA is set to rule on whether to approve Nuvalent’s ROS1 inhibitor zidesamtinib in September and reach a decision on the biotech’s ALK inhibitor neladalkib in November. With two near-approval assets, plus a phase 1 HER2 inhibitor and preclinical programs, the deal offers near-term growth drivers to ease the pressure GSK could face as generics erode sales of a key HIV drug from 2028 to 2030.“Subject to FDA approvals, the acquisition will deliver revenue growth from 2027. This is what our investors have been asking,” GSK CEO Luke Miels said on a call with the media early Tuesday morning. “It will strengthen our operating profit for GSK through the dolutegravir loss of exclusivity period.”Nuvalent filed for FDA approval of zidesamtinib in ROS1-positive non-small cell lung cancer (NSCLC) patients who have previously received a tyrosine kinase inhibitor (TKI). Before accepting GSK’s offer, the biotech said (PDF) it planned to apply to expand the label in the second half of the year to include patients without prior TKI exposure.Zidesamtinib could pose a threat to Pfizer’s TKI inhibitor Xalkori, which Nuvalent named as the first-line standard of care. Treatment guidelines also recommend (PDF) Roche’s Rozlytrek, Bristol Myers Squibb’s Augtyro and Nuvation Bio’s Ibtrozi, especially against brain metastases. Nuvalent has identified improved durability and reduced central nervous system side effects as ways to differentiate zidesamtinib.The FDA is reviewing neladalkib in TKI-pretreated, ALK-positive NSCLC. Nuvalent is enrolling patients in a phase 3 trial that is pitting the ALK inhibitor against Roche’s Alecensa in TKI-naive patients. Alecensa is the first-line standard of care and Pfizer’s Lorbrena is the preferred second-line treatment, according to Nuvalent. Miels named a recent seven-year analysis of Pfizer’s phase 3 Crown study as a driver of GSK\'s interest in neladalkib. The data showed Pfizer’s Lorbrena “has very good efficacy but a very, very difficult side effect profile to manage,” Miels said. Because patients are often relatively young, the downsides to a drug that impacts their ability to care for their kids and lead active lives are particularly severe, Miels said.The duration of treatment factored into GSK’s valuation of Nuvalent. The target mutations are found in a small subset of patients—about 3% to 5% of people with NSCLC are ALK-positive—but patients who are eligible for treatment spend longer on the drugs than is typical for many cancers. That means there are “very long tails to these products,” Miels said. About 1% to 3% of patients have ROS1 mutations. GSK sees “multiblockbuster potential” for zidesamtinib and neladalkib, leading it to agree to pay $124 a share to buy the biotech. Nuvalent’s stock closed at $88.49 on Monday. The outlay is well beyond the $2 billion to $4 billion deal range that Miels targeted after becoming CEO early this year. Yet the GSK leader maintained that the Nuvalent buyout is in line with the types of deals the company has been pursuing and striking. The difference is that instead of paying up to $4 billion for a biotech with one attractive asset, GSK is paying $10.6 billion for a company with multiple molecules of interest. “If you take apart the components, it\'s consistent with our approach so far,” Miels said. If zidesamtinib or neladalkib wins FDA approval, the deal will accelerate GSK’s entry into lung cancer and provide a potential launchpad for its B7-H3 antibody-drug conjugate (ADC) risvutatug rezetecan. GSK started a phase 3 trial of the ADC in small cell lung cancer last year.

Phase 3AcquisitionPhase 1Drug ApprovalADC

09 Jun 2026

·allsci.com

Chugai enters post-lorlatinib ALK resistance race with AQUA07 trial

Japan-based Chugai Pharmaceutical Co., Ltd. (TSE: 4519) has registered a first-in-human Phase I clinical trial of AQUA07, an oral investigational drug whose mechanism has not been publicly disclosed, in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on at least one prior ALK inhibitor. The AQUA07 clinical trial is notable for its parallel-arm structure: one arm evaluates AQUA07 as monotherapy, while a second tests it in combination with lorlatinib, Pfizer’s third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI). The design suggests Chugai may be positioning AQUA07 to address resistance mechanisms that emerge after exposure to later-generation ALK inhibitors — a setting where durable options remain limited. The Phase I, open-label, multicenter study (NCT07617337) is expected to enroll approximately 102 adults with locally advanced unresectable or metastatic ALK-positive NSCLC, according to the trial record. Patients must have received at least one prior ALK TKI, though those treated exclusively with crizotinib — the first-generation agent — are excluded, effectively enriching the population for individuals who have progressed on second- or third-generation inhibitors such as alectinib, brigatinib, or lorlatinib itself. The study is structured in two parallel dose-escalation parts: Part A evaluates AQUA07 monotherapy, and Part B evaluates AQUA07 in combination with lorlatinib, with each arm seeking to establish the recommended Phase II dose and maximum tolerated dose. Recruitment is anticipated to begin in Q3 2026, with primary completion targeted for August 2030. Secondary endpoints include pharmacokinetic profiling of both AQUA07 and lorlatinib, as well as preliminary efficacy measures — objective response rate, progression-free survival, and duration of response — assessed per RECIST v1.1. The biological rationale for AQUA07 cannot be fully characterized from available public sources; Chugai has not disclosed the compound’s molecular target or mechanism of action ahead of trial initiation, which is consistent with the company’s practice for early-stage internal programs. The oral route of administration and classification as a small-molecule drug are confirmed by the trial record, suggesting a kinase inhibitor-type modality, though this remains an inference. The decision to pair AQUA07 with lorlatinib in a dedicated dose-escalation arm — rather than simply evaluating monotherapy activity — implies the compound may act on a pathway distinct from or complementary to direct ALK kinase inhibition, potentially addressing bypass signaling or resistance mutations that limit the durability of ALK TKI monotherapy. Chugai has prior expertise in ALK-positive NSCLC through its development of alectinib (Alecensa), a second-generation ALK inhibitor now widely used as a first-line standard of care. In the post-lorlatinib resistance setting, the competitive field is sparse but active. The most advanced program is Nuvalent‘s neladalkib (NVL-655), a brain-penetrant next-generation ALK inhibitor designed to overcome a broad range of resistance mutations, including compound mutations that can emerge following sequential ALK TKI treatment. The agent is currently under US FDA review following positive pivotal data from the ALKOVE program. Chugai’s decision to evaluate AQUA07 both as monotherapy and in combination with lorlatinib suggests a potentially differentiated strategy, although the absence of a disclosed molecular target makes direct comparisons premature. Trial identifier: NCT07617337. Sponsor: Chugai Pharmaceutical Co., Ltd. Status: Not yet recruiting. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 Deals associated with Alectinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10450	Alectinib Hydrochloride	L01XE	DB11363

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ALK Positive Solid Tumors	Japan	Chugai Pharmaceutical Co., Ltd.	18 May 2026
Resectable Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	19 Jun 2024
ALK-positive anaplastic large cell lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	21 Feb 2020
Advanced Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	16 Feb 2017
Non-Small Cell Lung Cancer	Canada	Hoffmann-La Roche Ltd.	29 Sep 2016
ALK positive Non-Small Cell Lung Cancer	United States	Hoffmann-La Roche, Inc.	11 Dec 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anaplastic Large-Cell Lymphoma	Phase 3	United Kingdom	-	18 Dec 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	18 Dec 2023
Neuroblastoma	Phase 3	United Kingdom	-	18 Dec 2023
Renal Cell Carcinoma	Phase 3	United Kingdom	-	18 Dec 2023
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Nov 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Hoffmann-La Roche, Inc.	01 Nov 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	Hoffmann-La Roche, Inc.	01 Nov 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	Hoffmann-La Roche, Inc.	01 Nov 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	Hoffmann-La Roche, Inc.	01 Nov 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	Hoffmann-La Roche, Inc.	01 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ELCC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	55	Adjuvant Alectinib	vdogpbvomq(gupcislumk) = zdepuajacu kzavdvmect (prbzzvseyz ) View more	Positive	25 Mar 2026
J-ALEX (ESMO_ASIA2025)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK secondary mutations (SMs)	67	Alectinib	nhdyodlusx(jtnweoeuwu) = lsvoezzvss talwsabgtx (zrxkxshzyw ) View more	Positive	05 Dec 2025
				Alectinib (Patients with detected ALK SMs)	nhdyodlusx(fqysukmcye) = pkltdmgndb zddfvjdflw (hkbfncaikc, 10.2 - 25.2)
ESMO_ASIA2025	Not Applicable	ALK positive Lung Cancer	70	Crizotinib	cftcbigaoc(groksuyfkm) = udskaaamcv tlupwxjcbg (drtfcfquvg, 34 - 65) View more	Positive	05 Dec 2025
NCT02075840 (ALEX, ESMO2025) Manual	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK Positive	303	Alectinib 600 mg BID	ypytjuijak(ylysykoiyz) = gkvwnjhmdl vbpwyuhdvx (irkvrnyknj, 62.3 - NE) View more	Positive	17 Oct 2025
				Crizotinib 250 mg BID	ypytjuijak(ylysykoiyz) = kfaosrldjh vbpwyuhdvx (irkvrnyknj, 34.6 - 75.6) View more
ESMO2025	Not Applicable	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	48	Alectinib 600 mg BID	keldiqnvwg(erwnwifvnx) = wketvcgfvb vmjxydiigj (fczquzlgqf ) View more	Positive	17 Oct 2025
				Crizotinib 250 mg BID	keldiqnvwg(erwnwifvnx) = dhwoziydwy vmjxydiigj (fczquzlgqf ) View more
ESMO2025	Not Applicable	Non-Small Cell Lung Cancer	12,820	Osimertinib	zhwhntumju(arrndiktax) = zdwbqtupro uyfilkovql (mdvqwujxna, 0.7 - 1.4) View more	Positive	17 Oct 2025
				Alectinib	zhwhntumju(arrndiktax) = llbwyeieyd uyfilkovql (mdvqwujxna, 0.2 - 0.6) View more
NCT02737501 \| NCT01970865 \| NCT02075840 \| NCT02604342 \| NCT02094573 \| NCT03052608 (1027 Study EXP2-3A, WCLC2025) Manual	Not Applicable	ALK positive Non-Small Cell Lung Cancer Second line \| First line ALK Positive	-	lorlatinib+alectinib+chemotherapy	ohecouohwd(nxgwjsfved) = yycfzojcrv axlckadzty (ixohrtybey ) View more	Positive	09 Sep 2025
				lorlatinib+brigatinib+chemotherapy	ohecouohwd(nxgwjsfved) = ebzobbemar axlckadzty (ixohrtybey ) View more
NCT04302025 (NAUTIKA1, WCLC2025)	Phase 2	ALK positive Non-Small Cell Lung Cancer Neoadjuvant ALK+	33	Neoadjuvant Alectinib 600mg BID	nkxrqcnkho(wvoeorgtgj) = mjixnumnaz cpjpwsyaky (avxndqbxtk ) View more	Positive	09 Sep 2025
NCT04302025 (NAUTIKA1, WCLC2025)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant \| Adjuvant ALK positive	33	alectinib+Platinum containing dual drug chemotherapy	prgdqjddeq(mdnhrkpskf) = fwoffzllir vdlxjkbnoh (swybaznavz ) View more	Positive	08 Sep 2025
NCT05015010 (ALNEO, ASCO2025) Manual	Phase 2	ALK positive Non-Small Cell Lung Cancer Adjuvant \| Neoadjuvant	33	Alectinib	hsnfxrmmcz(kymemtwbka) = mpxmbcrnzc gaewdxqxsf (kiwzgsugfm, 31 - 61) Met View more	Positive	30 May 2025

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