Evidence map›Paper›PMID 41896648›Full record

Trial reportNature medicine2026

Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial.

Byoung Chul Cho, Rama Balaraman, Hua-Jun Chen, Xinmin Yu, Adewale Fawole, Zhi-Gang Liu, Jiliang Zhang, Long Wu, Bin Yang, Jennifer L Leddon and 29 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05671510 (Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors), which is not on this map. Not yet cited in PubMed.

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

NCT05671510 phase3active not recruitingnot on this map

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

TypeinterventionalSponsorOncoC4, Inc.Ran2023 to 2028Enrolled630ConditionsNon Small Cell Lung CancerArmsGotistobart, Docetaxel
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

39 authors.

Byoung Chul ChoDivision of Medical Oncology, Yonsei Cancer Center, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-5562-270X
Rama BalaramanOcala Oncology Center PL, Ocala, FL, USA.
Hua-Jun ChenGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China.
Xinmin YuZhejiang Cancer Hospital, Hangzhou, China.
Adewale FawoleFlorida Cancer Specialists and Research Institute, The Villages, FL, USA.
Zhi-Gang LiuCancer Center, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital), Guangzhou, China.ORCID http://orcid.org/0000-0003-4043-3196
Jiliang ZhangChengdu Seventh People's Hospital, Sichuan, China.
Long WuRenmin Hospital of Wuhan University, Wuhan, China.
Bin YangHubei Cancer Hospital, Wuhan, China.
Jennifer L LeddonUniversity of Cincinnati, Cincinnati, OH, USA.
John HammNorton Cancer Institute, Louisville, KY, USA.
Yanjing HuangHainan General Hospital, Haikou, China.
Lin WuHunan Cancer Hospital, Changsha, China.ORCID http://orcid.org/0000-0001-7078-7767
Pinhua PanXiangya Hospital, Central South University, Changsha, China.
Preet SinghSpringfield Clinic Cancer Center, Springfield, IL, USA.
Andrew BeardsleyMessino Cancer Center, Asheville, NC, USA.
Fadi KayaliFlorida Cancer Specialists, Sarasota, FL, USA.
Ardalan DavarifarThe University of Tennessee Medical Center, Knoxville, TN, USA.ORCID http://orcid.org/0000-0002-8779-2893
Ki Hyeong LeeChungbuk National University Hospital, Cheongju, Republic of Korea.
Keon-Uk ParkKeimyung University Dongsan Hospital, Daegu, Republic of Korea.
Youngjoo LeeNational Cancer Center, Goyang, Republic of Korea.
Luchun LiChongqing Cancer Hospital, Chongqing, China.
Xicheng WangThe First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China.ORCID http://orcid.org/0000-0002-8490-9785
Meili SunJinan Central Hospital, Jinan, China.ORCID http://orcid.org/0000-0002-4914-6508
Yan YuHarbin Medical University-Tumor Hospital (The Third Affiliated Hospital), Harbin, China.
Vikram JainMater Hospital, South Brisbane, Queensland, Australia.
Svetlana ShpyroBioNTech SE, Mainz, Germany.
Qiong WangBioNTech US Inc., Cambridge, MA, USA.
Michael WengerBioNTech SE, Mainz, Germany.ORCID http://orcid.org/0000-0003-1706-0029
Uğur ŞahinBioNTech SE, Mainz, Germany.ORCID http://orcid.org/0000-0003-0363-1564
Sergey EfuniOncoC4 Inc., Rockville, MD, USA.
Shiling SongOncoC4 Inc., Rockville, MD, USA.
Kun HeR&G US, Inc., North Potomac, MD, USA.ORCID http://orcid.org/0000-0002-2697-8635
Pan ZhengOncoC4 Inc., Rockville, MD, USA.
Yang LiuOncoC4 Inc., Rockville, MD, USA.ORCID http://orcid.org/0000-0002-9442-700X
Kai HeThe Ohio State University James Cancer Hospital, Pelotonia Institute for Immuno-Oncology, Columbus, OH, USA. kai.he@osumc.edu.ORCID http://orcid.org/0000-0002-4378-9297
Tianhong LiUC Davis Comprehensive Cancer Center, Sacramento, CA, USA. thli@health.ucdavis.edu.ORCID http://orcid.org/0000-0001-7422-3520
Mark A SocinskiAdventHealth Cancer Institute, Orlando, FL, USA. mark.socinski.md@adventhealth.com.ORCID http://orcid.org/0000-0003-2915-9325
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. syylwu@live.cn.ORCID http://orcid.org/0000-0002-3611-0258

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI KC KENT LLOYD · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

PRESERVE-003 is a two-stage phase 3 trial evaluating gotistobart (BNT316/ONC-392), a novel pH-sensitive anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody that selectively depletes regulatory T cells within the tumor microenvironment, in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on programmed cell death protein/programmed death ligand 1 inhibitor/platinum-based chemotherapy-a population with a poor prognosis. Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel. Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Squamous CellDocetaxelLung NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedNeoplasm MetastasisDocetaxel

Identifiers

PMID41896648
PMCPMC13278949

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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.