Evidence map›Paper›PMID 40379690›Full record

Trial reportNature communications2025

Alectinib in combination with bevacizumab as first-line treatment in ALK-rearranged non-small cell lung cancer (ALEK-B): a single-arm, phase 2 trial.

Oscar Arrieta, Luis Lara-Mejía, Eduardo Rios-Garcia, Enrique Caballé-Perez, Luis Cabrera-Miranda, Maritza Ramos-Ramírez, David Dávila-Dupont, Andrés F Cardona, Graciela Cruz-Rico, Jordi Remon and 2 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03779191 (Phase II, Open Label, Single Arm Trial of Alectinib in Combination With Bevacizumab in Untreated and Previously Treated Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03779191 phase2completednot on this map

Phase II, Open Label, Single Arm Trial of Alectinib in Combination With Bevacizumab in Untreated and Previously Treated Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) With Positive ALK Driver Mutation

TypeinterventionalSponsorInstituto Nacional de Cancerologia de MexicoRan2020 to 2022Enrolled41ConditionsALK Gene Rearrangement Positive, Non-Squamous Non-Small Cell Neoplasm of LungArmsAlectinib, Bevacizumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Brain metastasis: Opportunities for novel therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Oscar ArrietaThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México. oscararrietaincan@gmail.com.ORCID http://orcid.org/0000-0002-1164-3779
Luis Lara-MejíaThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Eduardo Rios-GarciaThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.ORCID http://orcid.org/0000-0002-2422-1671
Enrique Caballé-PerezThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Luis Cabrera-MirandaThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Maritza Ramos-RamírezThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
David Dávila-DupontThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Andrés F CardonaDirection of Research, Science, and Education, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia.
Graciela Cruz-RicoThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Jordi RemonDepartment of Cancer Medicine, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0002-9462-875X
Alexandra Garcilazo-ReyesThoracic Oncology Unit, Instituto Nacional de Cancerología (INCan), Mexico City, México.
Rafael RosellOncology Institute Dr. Rosell, IOR, Dexeus University Hospital, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Up to 25% of patients with ALK-rearranged non-small cell lung cancer (NSCLC) experience disease progression within the first year of targeted therapy. This phase 2 trial investigates whether combining alectinib with bevacizumab can delay resistance mechanisms in advanced ALK-rearranged NSCLC. ALEK-B was an open-label, single-arm, single-center phase 2 trial (NCT03779191) evaluating alectinib (600 mg BID) and bevacizumab (15 mg/kg) in patients with advanced ALK-rearranged NSCLC confirmed by next-generation sequencing. The primary endpoint was the 12-month progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), intracranial progression-free survival (icPFS), safety, and patient-reported quality of life (QoL). Between April 2020 and August 2022, 41 patients were enrolled, including 17.1% with brain metastases. As of December 14, 2023, with a median follow-up of 34.5 months, the 12-month PFS rate was 97.1% (95% CI 92.6-100). The 36-month PFS and OS rates were 64.2% (95% CI 56.1-85.2) and 87.9% (95% CI 74-96.6), respectively. The ORR was 100%, and the 36-month icPFS rate was 87.8% (95% CI 74.0-96.6). Grade 3-4 adverse events occurred in 46.3% of patients, most commonly proteinuria and hepatotoxicity, with no fatal events reported. QoL significantly improved from baseline at 12 months and was maintained through 36 months. These findings support the efficacy and safety of alectinib plus bevacizumab and justify further investigation in ALK-rearranged NSCLC.

Indexed as

Anaplastic Lymphoma KinaseAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarbazolesCarcinoma, Non-Small-Cell LungLung NeoplasmsPiperidinesAdultAgedFemaleGene RearrangementHumansMaleMiddle AgedProgression-Free SurvivalQuality of LifealectinibALK protein, humanAnaplastic Lymphoma KinaseBevacizumabCarbazolesPiperidines

Identifiers

PMID40379690
PMCPMC12084566

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.