Evidence map›Paper›PMID 41702354›Full record

Trial reportESMO open2026

Fast Real-Time Assessment of Combination Therapies in Immuno-ONcology in patients with advanced non-small-cell lung cancer (FRACTION-Lung).

K He, P M Forde, R Govindan, A Santoro, S Gettinger, H Borghaei, A Spira, Q Chu, R Zinner, A J Schoenfeld and 10 more

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

Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02750514 (A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer), 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.

NCT02750514 phase2terminatednot on this map

A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2020Enrolled295ConditionsAdvanced CancerArmsNivolumab, Dasatinib, Relatlimab, Ipilimumab, BMS-986205
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

20 authors.

K HeDepartment of Internal Medicine, Division of Medical Oncology, The James Comprehensive Cancer Center, Pelotonia Institute for Immuno-Oncology, The Ohio State University, Columbus, USA. Electronic address: kai.he@osumc.edu.
P M FordeDepartment of Medical Oncology, Trinity St. James's Cancer Institute, Trinity College Dublin, Ireland.
R GovindanDivision of Oncology, Department of Medicine, Washington University, St. Louis, USA.
A SantoroDepartment of Oncology and Hematology, IRCCS Humanitas Research Hospital, Humanitas Cancer Center, Milan, Italy.
S GettingerDepartment of Internal Medicine, Section of Medical Oncology, Yale Cancer Center, Yale University, New Haven, USA.
H BorghaeiDepartment of Hematology/Oncology, Fox Chase Cancer Center, Temple University Health System, Philadelphia, USA.
A SpiraDepartment of Medical Oncology, Virginia Cancer Specialists, Fairfax, USA.
Q ChuDepartment of Oncology, Cross Cancer Institute, University of Alberta/Alberta Health Services, Edmonton, Canada.
R ZinnerDivision of Medical Oncology and Hematology, Department of Internal Medicine, Markey Cancer Center, University of Kentucky, Lexington, USA.
A J SchoenfeldDepartment of Medicine, Thoracic Oncology Service, Memorial-Sloan Kettering Cancer Center, New York, USA.
D R CamidgeDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, USA.
D R SpigelDepartment of Medical Oncology, Sarah Cannon Research Institute, Nashville, USA.
A GurpideDepartment of Oncology, Clinica Universidad de Navarra, Pamplona, Navarra, Spain.
R A JuergensDivision of Medical Oncology, Department of Oncology, Juravinski Cancer Centre, McMaster University, Hamilton, Canada.
S A LaurieDivision of Medical Oncology, Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
M CerraBristol Myers Squibb, Princeton, USA.
T SpiresBristol Myers Squibb, Princeton, USA.
D M GreenawaltBristol Myers Squibb, Princeton, USA.
I RapoportBristol Myers Squibb, Princeton, USA.
J F GainorDepartment of Medicine, Division of Hematology and Oncology, Massachusetts General Hospital/Harvard Medical School, Boston, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe phase II FRACTION-Lung platform trial (NCT02750514) aimed to evaluate novel immunotherapy combinations in advanced non-small-cell lung cancer (aNSCLC). PATIENTS AND

methodsAdults with aNSCLC and Eastern Cooperative Oncology Group performance status ≤1 were allocated to tracks 1 to 5 based on programmed cell death protein (ligand) 1 [PD-(L)1] status and/or prior receipt of anti-PD-(L)1 therapy, and received nivolumab (anti-PD-1) as monotherapy or combination therapy [dasatinib (multi-kinase inhibitor), ipilimumab (anti-CTLA-4), relatlimab (anti-LAG-3), or linrodostat (IDO1 inhibitor)]. Patients with progression in one arm could be re-randomized. Primary endpoints were objective response rate (ORR); duration of response (DOR); and 24-week progression-free survival (PFS) rate. Safety was a secondary endpoint; biomarker analyses were exploratory.

resultsOverall, 295 patients were treated (191 received no prior immunotherapy, 118 received prior immunotherapy; 14 were re-randomized assigned). Among patients without prior immunotherapy, ORRs ranged from 0% (multiple arms) to 25% (nivolumab plus ipilimumab: 3/12 patients; nivolumab plus dasatinib: 1/4 patients), and among patients with prior immunotherapy from 2.3% (nivolumab plus linrodostat: 1/43 patients) to 5.6% (nivolumab plus ipilimumab: 1/18 patients). Median DOR was not estimated due to limited tumor responses. Twenty-four-week PFS rates ranged from 30.2% [nivolumab-only (n = 40)] to 45.5% [nivolumab plus ipilimumab (n = 12)] among patients without prior immunotherapy and 11.1% [nivolumab plus linrodostat (n = 43)] to 19.1% [nivolumab plus dasatinib (n = 41)] among patients with prior immunotherapy. No new safety signals were observed. Small sample sizes in each treatment group limited analyses, including biomarkers. The study was discontinued early due to an evolving treatment landscape and limited efficacy signals. Given the rolling, adaptive design, this trial was not statistically powered to assess treatment benefits and draw definitive efficacy conclusions, as early termination and the changing standard of care limited accrual.

conclusionsDespite limited efficacy, the innovative adaptive trial design allowed rapid evaluation of multiple regimens, which may inform future trials.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungImmunotherapyLung NeoplasmsAdultAgedFemaleHumansIpilimumabMaleMiddle AgedNivolumabIpilimumabNivolumabcombination therapyimmune checkpoint inhibitorsimmunotherapynivolumabplatform trial

Identifiers

PMID41702354
PMCPMC12925557

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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.