Evidence map›Paper›PMID 31346927›Full record

ArticleTargeted oncology2019

Phase I Trial of Targeted EGFR or ALK Therapy with Ipilimumab in Metastatic NSCLC with Long-Term Follow-Up.

Anna W Chalmers, Shiven Patel, Ken Boucher, Laura Cannon, Michelle Esplin, Julie Luckart, Natalie Graves, Terry Van Duren, Wallace Akerley

2 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Targeted oncology, 2019. 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 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT01998126 phase1completednot on this map

Evaluation of Combination Checkpoint Inhibitor Plus Targeted Inhibitor (Erlotinib or Crizotinib) for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer: Phase Ib With Expansion Cohorts

TypeinterventionalSponsorUniversity of UtahRan2013 to 2018Enrolled14ConditionsNon-small Cell Lung CancerArmsIpilimumab, Erlotinib, Crizotinib, Nivolumab
NCT04141644 phase1active not recruitingnot on this mapstarted 2020, after this paper: background citation

A Phase Ib Study to Evaluate the Safety and Efficacy of Osimertinib in Combination With Ipilimumab in Patients With EGFR Mutated Non-Small-Cell Lung Cancer Tumors

TypeinterventionalSponsorUniversity of UtahRan2020 to 2028Enrolled24ConditionsNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)ArmsIpilimumab, Osimertinib
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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  5. EGFR: New Insights on Its Activation and Mutation in Tumor and Tumor Immunotherapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
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  6. [Progress of Immunotherapy in EGFR-mutated Advanced Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2024
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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

9 authors at 1 institution in 1 country.

Anna W ChalmersHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA. Anna.chalmers@hci.utah.edu.ORCID http://orcid.org/0000-0003-4832-0022
Shiven PatelHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Ken BoucherHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Laura CannonHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Michelle EsplinHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Julie LuckartHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Natalie GravesHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Terry Van DurenHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
Wallace AkerleyHuntsman Cancer Institute, University of Utah, 1950 Cir of Hope Dr, Salt Lake City, UT, 84112, USA.
University of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe natural histories of, and treatment options for, epidermal growth factor receptor (EGFR)-mutated and anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancers (NSCLCs) are distinctly different from those of lung cancer that lacks actionable mutations. Ipilimumab is a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor that has been approved in other malignancies.

objectiveA phase I trial of ipilimumab plus targeted therapy with either erlotinib or crizotinib was performed to assess the safety of the combination in patients with EGFR-mutated or ALK-rearranged advanced NSCLC.

methodsPatients with EGFR-mutated or ALK-rearranged NSCLC on a stable dose of erlotinib or crizotinib for > 28 days were eligible for the study. Patients were treated with ipilimumab 3 mg/kg for four cycles plus erlotinib or crizotinib.

resultsTreatment of the EGFR cohort resulted in dose-limiting toxicity in three of eight patients, with grade 3 diarrhea. The protocol was amended to reduce the ipilimumab dose to 1 mg/kg. Excessive toxicity resulted in the study being closed after 14 patients. Four of 11 EGFR-mutated patients ultimately developed grade 3 colitis. Of three ALK-rearranged patients, one developed hypophysitis and another grade 2 pneumonitis. For 11 EGFR-mutated patients, progression-free survival (PFS) from the start of ipilimumab was 17.9 months. Erlotinib treatment began a median 7.7 months before ipilimumab; therefore, erlotinib PFS was 27.8 months. Median overall survival (OS) has not been reached but will be > 42.3 months from erlotinib initiation. For three ALK-rearranged patients, ipilimumab PFS was 24.1 months. Median OS has not been reached but will be at least 47.2 months from the initiation of crizotinib.

conclusionErlotinib plus ipilimumab caused excessive short-term gastrointestinal toxicity leading to early study closure. However, PFS and OS were notable; therefore, targeted therapies with immunotherapy in NSCLC merit further study. Clinicaltrials.gov registration number: NCT01998126.

Indexed as

Anaplastic Lymphoma KinaseAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleFollow-Up StudiesHumansIpilimumabLung NeoplasmsMaleNeoplasm MetastasisProspective StudiesAnaplastic Lymphoma KinaseAntineoplastic Agents, ImmunologicalErbB ReceptorsIpilimumab

Identifiers

PMID31346927
OpenAlexW2963997426

What OpenQuestion holds

Textmetadata
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.