Evidence map›Paper›PMID 33231285›Full record

Trial reportInternational journal of cancer2021

Randomized clinical trial of pembrolizumab vs chemotherapy for previously untreated Chinese patients with PD-L1-positive locally advanced or metastatic non-small-cell lung cancer: KEYNOTE-042 China Study.

Yi-Long Wu, Li Zhang, Yun Fan, JianYing Zhou, Li Zhang, Qing Zhou, Wei Li, ChengPing Hu, GongYan Chen, Xin Zhang and 7 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 79 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 14 pooled it
5.3field-weighted citation impact, top 3% of its field
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.

NCT02220894 phase3completednot on this map

A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2022Enrolled1,274ConditionsNon-small Cell Lung CancerArmspembrolizumab, carboplatin, paclitaxel, pemetrexed
NCT03850444 phase3completednot on this map

A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2016 to 2022Enrolled262ConditionsNon-small Cell Lung CancerArmspembrolizumab, carboplatin, paclitaxel, pemetrexed
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 14 syntheses or guidelines pooled it, 95 citations in OpenAlex.

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19 more citing papers are in PubMed but not listed here.

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

17 authors at 12 institutions in 3 countries.

Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.ORCID 0000-0002-3611-0258
Li ZhangPeking Union Medical College Hospital, Beijing, China.
Yun FanThe Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
JianYing ZhouThe First Affiliated Hospital of Zhejiang University, Hangzhou, China.
Li ZhangSun Yat-Sen University Cancer Center, Guangzhou, China.
Qing ZhouGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
Wei LiThe First Hospital of Jilin University, Changchun, China.
ChengPing HuXiangya Hospital-Central South University, Changsha, China.
GongYan ChenThe Third Affiliated Hospital of Harbin Medical University, Harbin, China.
Xin ZhangZhongshan Hospital Fudan University Respiratory Diseases Department, Shanghai, China.
CaiCun ZhouShanghai Pulmonary Hospital and Tongji University School of Medicine, Shanghai, China.
Thao DangMerck & Co., Inc., Kenilworth, New Jersey, USA.
Sara SadowskiMerck & Co., Inc., Kenilworth, New Jersey, USA.
Debra A KushMerck & Co., Inc., Kenilworth, New Jersey, USA.
Yu ZhouMSD China, Shanghai, China.
Ben LiMSD China, Shanghai, China.
Tony MokState Key Laboratory of Translation Oncology, Chinese University of Hong Kong, Hong Kong, China.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USGuangdong Academy of Medical Sciences · CNMSCI (China) · CNSun Yat-sen University · CNCentral South University · CNChinese University of Hong Kong · HKFirst Affiliated Hospital Zhejiang University · CNFudan University · CNHarbin Medical University · CNJilin University · CNTongji University · CNZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the global KEYNOTE-042 study (Clinicaltrials.gov, NCT02220894), pembrolizumab significantly improved overall survival (OS) vs chemotherapy in patients with previously untreated programmed death ligand 1 (PD-L1)-positive locally advanced/metastatic non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations. We present results from patients in KEYNOTE-042 enrolled from China in the global or extension study (NCT03850444; protocol identical to global study). Patients were randomized 1:1 (stratified by ECOG performance status 0 vs 1, squamous vs nonsquamous histology and PD-L1 tumor proportion score [TPS] ≥50% vs 1%-49%) to 35 cycles of pembrolizumab 200 mg every 3 weeks (Q3W) or investigator's choice of 4 to 6 cycles of carboplatin plus paclitaxel or pemetrexed Q3W with optional pemetrexed maintenance for nonsquamous tumors. Primary endpoints were OS in patients with PD-L1 TPS ≥50%, ≥20% or ≥1%. Two hundred sixty-two patients (pembrolizumab, n = 128; chemotherapy, n = 134) were enrolled from China. At data cutoff (February 21, 2020; median follow-up, 33.0 [range, 25.6-41.9] months), pembrolizumab was shown to improve OS vs chemotherapy in patients with PD-L1 TPS ≥50% (hazard ratio [95% CI], 0.63 [0.43-0.94]), TPS ≥20% (0.66 [0.47-0.92]) and TPS ≥1% (0.67 [0.50-0.89]). Grade 3 to 5 treatment-related adverse events occurred less frequently with pembrolizumab vs chemotherapy (19.5% vs 68.8%). In 22 patients who completed 35 cycles of pembrolizumab, objective response rate was 77.3% and median duration of response was 27.6 months. Consistent with the global KEYNOTE-042 study, pembrolizumab improved OS vs chemotherapy in this study of Chinese patients with locally advanced/metastatic NSCLC and PD-L1 TPS ≥1%, supporting first-line pembrolizumab monotherapy for PD-L1-positive advanced/metastatic NSCLC in China.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungChinaFemaleHumansLung NeoplasmsMaleMiddle AgedYoung AdultAntibodies, Monoclonal, Humanizedpembrolizumabchemotherapynon-small-cell lung cancerpembrolizumabprogrammed death ligand 1

Identifiers

PMID33231285
PMCPMC8048589
OpenAlexW3107870684

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.