Evidence map›Paper›PMID 40366884›Full record

Trial reportCancer2025

Anlotinib in combination with docetaxel for advanced nonsmall cell lung cancer after failure of platinum-based treatment: A phase 1/2 trial.

Jiawei Shou, Jun Chen, Qunyi Guo, Wei Hong, Yonghui Wang, Chuangzhou Rao, Liqin Lu, Xinmei Yang, Dan Zhu, Fen Lan and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03726736 (Anlotinib Combined With Docetaxel Versus Docetaxel for Platinum-based Therapy Treated Advanced NSCLC), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03726736 phase1 / phase2unknown statusnot on this map

Anlotinib Combined With Docetaxel Versus Docetaxel for Platinum-based Therapy Treated Advanced NSCLC: a Multicentre, Randomised Explorative Trial

TypeinterventionalSponsorYong FangRan2018 to 2020Enrolled97ConditionsNon-small Cell Lung CancerArmsAnlotinib combined Docetaxel, Docetaxel
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jiawei ShouDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jun ChenDepartment of Tumor Radiochemotherapy, The Affiliated People's Hospital of NingBo University, Ningbo, China.
Qunyi GuoDepartment of Hematology Oncology, Taizhou Hospital of Zhejiang Province, Taizhou, China.
Wei HongDepartment of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine, Chinese Academy of Sciences, Hangzhou, China.
Yonghui WangDepartment of Medical Oncology, Thoracic Cancer, Lishui Municipal Central Hospital, Lishui, China.ORCID https://orcid.org/0000-0002-3172-2458
Chuangzhou RaoDepartment of Radiotherapy and Chemotherapy, Ningbo No. 2 Hospital, Ningbo, China.
Liqin LuDepartment of Medical Oncology, Zhejiang Provincial People's Hospital, Hangzhou, China.
Xinmei YangDepartment of Oncology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.
Dan ZhuDepartment of Pulmonary and Critical Care Medicine, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Fen LanDepartment of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Yong FangDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID https://orcid.org/0000-0002-0588-2116
Hongming PanDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Funding

China International Medical Fund Exchange Conference XS022Chinese Society of Clinical Oncology Health Project Y-MSD2020-0314Chinese Society of Clinical Oncology Health Project YQL2019-0316Health Commission of Zhejiang Province 2016KYA115Medical Science and Technology Project of Zhejiang Province 2016ZDB007Medical Science and Technology Project of Zhejiang Province 2017197380Medical Science and Technology Project of Zhejiang Province 2017ZD021National Key Research and Development Program of China 2021YPA1301104Natural Science Foundation of Zhejiang Province LQ16H160003Natural Science Foundation of Zhejiang Province LY13H160013Zhejiang Medical Innovative Discipline Construction Project-2016
6 · The paper itself

Abstract

backgroundThe combination of anlotinib with chemotherapy has demonstrated encouraging efficacy in the treatment of nonsmall cell lung cancer (NSCLC). The objective of this phase 1/2 trial was to establish the maximum tolerated dose of anlotinib in combination with docetaxel and to assess the efficacy and safety of this regimen in patients with advanced NSCLC who had progressed after platinum-based chemotherapy.

methodsIn the phase 1 trial, eight patients were enrolled to determine the maximum tolerated dose, which was identified as 10 mg for anlotinib in combination with docetaxel. In the phase 2 trial, in total, 88 patients were randomized, with 57 receiving anlotinib at the established maximum tolerated dose alongside docetaxel and 31 receiving docetaxel monotherapy. Tumor response was evaluated in 88 patients.

resultsIn the phase 2 study, the combination of anlotinib and docetaxel demonstrated a significant improvement in progression-free survival compared with docetaxel monotherapy (median, 5.39 vs. 2.56 months; hazard ratio, 0.36; 95% confidence interval, 0.21-0.63; p = .0002). The objective response rate was also superior in the combination group (26.32% vs. 6.45%). The median overall survival was 16.82 months for the combination group versus 9.86 months for the monotherapy group (hazard ratio, 0.89; 95% confidence interval, 0.47-1.66; p = .7114). Safety analysis included 96 patients, and the most frequent treatment-emergent adverse events were decreased neutrophil count and decreased white blood cell count.

conclusionsThe addition of anlotinib to docetaxel was characterized by a manageable safety profile and also resulted in a significant improvement in progression-free survival among patients with advanced NSCLC who had previously failed platinum-based chemotherapy (ClinicalTrials.gov identifier NCT03726736).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDocetaxelIndolesLung NeoplasmsQuinolinesAdultAgedFemaleHumansMaleMaximum Tolerated DoseMiddle AgedProgression-Free SurvivalanlotinibDocetaxelIndolesQuinolinesadvanced canceranlotinibdocetaxelnonsmall cell lung cancerphase 1/2

Identifiers

PMID40366884
PMCPMC12077655

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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.