Evidence map›Paper›PMID 37507657›Full record

Trial reportBMC cancer2023

A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer.

Ernest Nadal, Mansoor Saleh, Santiago Ponce Aix, Maria Ochoa-de-Olza, Sandip Pravin Patel, Scott Antonia, Yumin Zhao, Ivelina Gueorguieva, Michael Man, Shawn T Estrem and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02423343 (A Phase 1b/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of a Novel Transforming Growth Factor-beta Receptor I Kinase Inhibitor), which is not on this map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
14.5field-weighted citation impact, top 1% 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.

NCT02423343 phase1 / phase2completednot on this map

A Phase 1b/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of a Novel Transforming Growth Factor-beta Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors (Phase 1b) and in Recurrent or Refractory Non-small Cell Lung Cancer or Hepatocellular Carcinoma (Phase 2)

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2020Enrolled41ConditionsSolid Tumor, Non-Small Cell Lung Cancer Recurrent, Hepatocellular Carcinoma RecurrentArmsGalunisertib, Nivolumab
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 56 citations in OpenAlex.

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  8. Targeting Tumor-Associated Macrophages and Cancer-Associated Fibroblasts to Overcome Therapeutic Resistance in Hepatocellular Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  17. EMT and cancer: what clinicians should know.Nature reviews. Clinical oncology · 2025
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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

17 authors at 9 institutions in 2 countries.

Ernest NadalDepartment of Medical Oncology, Catalan Institute of Oncology, IDIBELL, L'Hospitalet, Barcelona, Spain. esnadal@iconcologia.net.
Mansoor SalehUniversity of Alabama, Birmingham, AL, USA.
Santiago Ponce AixHospital 12 de Octubre - Oncology, Madrid, Spain.
Maria Ochoa-de-OlzaHospital Universitario Vall d'Hebron, Barcelona, Spain.
Sandip Pravin PatelUniversity of California, San Diego, CA, USA.
Scott AntoniaH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Yumin ZhaoEli Lilly and Company, Indianapolis, IN, USA.
Ivelina GueorguievaEli Lilly and Company, Indianapolis, IN, USA.
Michael ManEli Lilly and Company, Indianapolis, IN, USA.
Shawn T EstremEli Lilly and Company, Indianapolis, IN, USA.
Jiangang LiuEli Lilly and Company, Indianapolis, IN, USA.
Emin AvsarEli Lilly and Company, Indianapolis, IN, USA.
Wen Hong LinBristol Myers Squibb, Princeton, NJ, USA.
Karim A BenhadjiEli Lilly and Company, Indianapolis, IN, USA.
Leena GandhiEli Lilly and Company, Indianapolis, IN, USA.
Susan C GubaEli Lilly and Company, Indianapolis, IN, USA.
Inmaculada Ales DiazUGCI Oncología Médica, Hospitales Universitarios Regional Y Virgen de La Victoria, IBIMA, Málaga, Spain.
Eli Lilly (United States) · USBristol-Myers Squibb (United States) · USInstitut Català d'Oncologia · ESInstituto de Investigación Biomédica de Málaga · ESMoffitt Cancer Center · USResearch Institute Hospital 12 de Octubre · ESUniversity of Alabama at Birmingham · USUniversity of California, San Diego · USVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this phase Ib/II open-label study, tumor immune suppression was targeted in patients with advanced refractory solid tumors and patients with recurrent/refractory non-small cell lung cancer (NSCLC) using galunisertib with nivolumab.

methodsEligible patients were ≥ 18 years old, had an Eastern Cooperative Oncology Group performance status ≤ 1, and were treatment-naive for anti-programmed cell death-1, its ligand, or transforming growth factor β receptor 1 kinase inhibitors. Phase Ib was an open-label, dose-escalation assessment of the safety and tolerability of galunisertib with nivolumab in patients with advanced refractory solid tumors. Phase II evaluated the safety of galunisertib with nivolumab in NSCLC patients who had received prior platinum-based treatment but were immuno-oncology agent-naive.

resultsThis trial was conducted between October 2015 and August 2020. No dose-limiting toxicities were observed in phase I. In the phase II NSCLC cohort (n = 25), patients received 150 mg twice daily galunisertib (14 days on/14 days off dosing schedule for all phases) plus nivolumab at 3 mg/kg (intravenously every 2 weeks). In this phase, the most frequent treatment-related adverse events (AEs) were pruritus (n = 9, 36%), fatigue (n = 8, 32%), and decreased appetite (n = 7, 28%). No grade 4 or 5 treatment-related AEs were observed. Six (24%) patients had confirmed partial response (PR) and 4 (16%) had stable disease; 1 additional patient had confirmed PR after initial pseudo-progression. The median duration of response was 7.43 months (95% confidence interval [CI]: 3.75, NR). Among the 7 responders, including the delayed responder, 1 had high PD-L1 expression (≥ 50%). The median progression-free survival was 5.26 months (95% CI: 1.77, 9.20) and the median overall survival was 11.99 months (95% CI: 8.15, NR). Interferon gamma response genes were induced post-treatment and cell adhesion genes were repressed, although the association of these observations with tumor response and clinical outcomes was not statistically powered due to limited samples available.

conclusionsThe study met its primary endpoint as galunisertib combined with nivolumab was well tolerated. Preliminary efficacy was observed in a subset of patients in the Phase 2 NSCLC cohort.

trial registrationTrial registered with ClinicalTrials.gov (NCT02423343; 22.04.2015).

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungLung NeoplasmsAdolescentAntineoplastic Combined Chemotherapy ProtocolsHumansNeoplasm Recurrence, LocalNivolumabPyrazolesQuinolinesAntineoplastic Agents, ImmunologicalLY-2157299NivolumabPyrazolesQuinolinesGalunisertibImmune checkpoint inhibitorNivolumabNSCLCTGF-β

Identifiers

PMID37507657
PMCPMC10386782
OpenAlexW4385342714

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.