Evidence map›Paper›PMID 39134529›Full record

Trial reportSignal transduction and targeted therapy2024

Gefitinib (an EGFR tyrosine kinase inhibitor) plus anlotinib (an multikinase inhibitor) for untreated, EGFR-mutated, advanced non-small cell lung cancer (FL-ALTER): a multicenter phase III trial.

Hua-Qiang Zhou, Ya-Xiong Zhang, Gang Chen, Qi-Tao Yu, Hua Zhang, Guo-Wu Wu, Di Wu, Ying-Cheng Lin, Jun-Fei Zhu, Jian-Hua Chen and 15 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04028778 (A Multicenter, Randomized, Double-Blind Study of Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
–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.

NCT04028778 phase3unknown statusnot on this map

A Multicenter, Randomized, Double-Blind Study of Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer

TypeinterventionalSponsorSun Yat-sen UniversityRan2019 to 2022Enrolled310ConditionsLung Cancer, Nonsmall CellArmsGefitinib, Anlotinib Hydrochloride, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

25 authors.

Hua-Qiang Zhou *Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.ORCID 0000-0003-3538-4481
Ya-Xiong Zhang *Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.ORCID 0000-0002-3632-0300
Gang Chen *Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.
Qi-Tao Yu *Department of Medical Oncology of Respirotary, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, 530021, China.
Hua Zhang *Department of Urogenital Oncology, the First People's Hospital of Foshan, Foshan, 52800, China.
Guo-Wu WuDepartment of Medical Oncology, Meizhou People's Hospital (Huangtang Hospital), Meizhou, 514031, China.
Di WuDepartment of Respiratory and Critical Care Medicine, Shenzhen people's Hospital, Shenzhen, 518020, China.
Ying-Cheng LinDepartment of Medical Oncology of Respirotary, Cancer Hospital of Shantou University Medical College, Shantou, 515031, China.
Jun-Fei ZhuDepartment of Respiratory and Critical Care Medicine, Taizhou Central Hospital, Taizhou, 318000, China.
Jian-Hua ChenDepartment of Medical Oncology, Hunan Provincial Cancer Hospital, Changsha, 410031, China.
Xiao-Hua HuDepartment of Medical Oncology, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, China.
Bin LanDepartment of Cardiothoracic Surgery, Shantou Central Hospital, Shantou, 515031, China.
Ze-Qiang ZhouDepartment of Oncology, the 2nd People's Hospital of Shenzhen, Shenzhen, 518025, China.
Hai-Feng LinDepartment of Medical Oncology, the Second Affiliated Hospital of Hainan Medical University, Haikou, 570216, China.
Zi-Bing WangDepartment of Immunotherapy, Henan Cancer Hospital, Zhengzhou, 450003, China.
Xiao-Lin LeiDepartment of Oncology, Affiliated Hospital of Panzhihua University, Panzhihua, 617099, China.
Suo-Ming PanDepartment of Radiotherapy, Yuebei People's Hospital, Shaoguan, 512099, China.
Li-Ming ChenDepartment of Oncology, the First Affiliated Hospital of Shantou University Medicine College, Shantou, 515041, China.
Jian ZhangDepartment of Oncology, ZhuJiang Hospital of Southern Medical University (The Second Clinical Medical College), Guangzhou, 510280, China.
Tian-Dong KongDepartment of Respiratory Oncology, the Third People's Hospital of Zhengzhou, Zhengzhou, 450001, China.
Ji-Cheng YaoShanghai OrigiMed Co., Ltd, Shanghai, China.
Xin ZhengShanghai OrigiMed Co., Ltd, Shanghai, China.
Feng LiShanghai OrigiMed Co., Ltd, Shanghai, China.
Li ZhangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China. zhangli@sysucc.org.cn.
Wen-Feng FangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China. fangwf@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dual inhibition of vascular endothelial growth factor and epidermal growth factor receptor (EGFR) signaling pathways offers the prospect of improving the effectiveness of EFGR-targeted therapy. In this phase 3 study (ClinicalTrial.gov: NCT04028778), 315 patients with treatment-naïve, EGFR-mutated, advanced non-small cell lung cancer (NSCLC) were randomized (1:1) to receive anlotinib or placebo plus gefitinib once daily on days 1-14 per a 3-week cycle. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS was observed for the anlotinib arm over the placebo arm (hazards ratio [HR] = 0.64, 95% CI, 0.48-0.80, P = 0.003). Particularly, patients with brain metastasis and those harboring EGFR amplification or high tumor mutation load gained significant more benefits in PFS from gefitinib plus anlotinib. The incidence of grade 3 or higher treatment-emergent adverse events was 49.7% of the patients receiving gefitinib plus anlotinib versus 31.0% of the patients receiving gefitinib plus placebo. Anlotinib plus gefitinib significantly improves PFS in patients with treatment-naïve, EGFR-mutated, advanced NSCLC, with a manageable safety profile.

Indexed as

Carcinoma, Non-Small-Cell LungErbB ReceptorsGefitinibIndolesLung NeoplasmsMutationProtein Kinase InhibitorsQuinolinesAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedanlotinibEGFR protein, humanErbB ReceptorsGefitinibIndolesProtein Kinase InhibitorsQuinolinesTyrosine Kinase Inhibitors

Identifiers

PMID39134529
PMCPMC11319491

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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.