Evidence map›Paper›PMID 37390616›Full record

Trial reportThe oncologist2024

Phase I/II Trial of Carboplatin, Nab-paclitaxel, and Pembrolizumab for Advanced Non-Small Cell Lung Cancer: Hoosier Cancer Research Network LUN13-175.

Ryan D Gentzler, Nisha A Mohindra, Shadia I Jalal, Karen L Reckamp, Richard D Hall, Nasser H Hanna, Young Kwang Chae, Marianna Koczywas, Irene B Helenowski, Jyoti D Patel

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
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

10 authors at 5 institutions in 1 country.

Ryan D GentzlerDepartment of Medicine, Division of Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA, USA.ORCID 0000-0002-8983-6677
Nisha A MohindraDepartment of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.ORCID 0000-0001-5913-1716
Shadia I JalalDepartment of Medicine, Division of Hematology/Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.ORCID 0000-0001-8938-7077
Karen L ReckampDepartment of Medicine, Division of Medical Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.ORCID 0000-0002-9213-0325
Richard D HallDepartment of Medicine, Division of Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA, USA.
Nasser H HannaDepartment of Medicine, Division of Hematology/Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.ORCID 0000-0002-7046-6426
Young Kwang ChaeDepartment of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.ORCID 0000-0003-1557-7235
Marianna KoczywasDepartment of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.ORCID 0000-0002-1588-6292
Irene B HelenowskiDepartment of Preventive Medicine, Northwestern University, Chicago, IL, USA.ORCID 0000-0003-1606-9013
Jyoti D PatelDepartment of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.
Northwestern University · USIndiana University Health · USUniversity of Virginia Cancer CenterCedars-Sinai Medical Center · USCity of Hope · US

Funding

Celgene IncMerck & Co., IncMerck Sharp & Dohme LLC
6 · The paper itself

Abstract

backgroundCombination chemotherapy and immunotherapy regimens have significantly improved survival for patients with previously untreated advanced non-small cell lung cancer (NSCLC). Improvements in overall survival (OS) in two separate pembrolizumab trials have demonstrated survival improvements over chemotherapy alone, regardless of PD-L1 status. The optimal chemotherapy backbone for combination with immunotherapy is unknown. We hypothesized nab-paclitaxel may be a well-suited platinum partner to use in combination with checkpoint inhibitor therapy for both adenocarcinoma and squamous histology and conducted a phase I/II trial to assess the efficacy of this regimen in advanced NSCLC.

methodsAdult patients with previously untreated, stage IIIB/IV NSCLC (any histology) with an Eastern Cooperative Oncology Group performance status of 0-1, any PD-L1 expression, and no EGFR mutations or ALK translocations, received carboplatin area under the curve (AUC) 6 day 1, nab-paclitaxel 100 mg/m2 days 1, 8, 15, and pembrolizumab 200 mg day 1 q21 days for 4 cycles followed by maintenance pembrolizumab q3w. Co-primary endpoints were progression-free survival (PFS) and overall response rate (ORR).

resultsForty-six evaluable patients enrolled, 14 in phase I and 32 in phase II, from June 2015 to July 2018 with a median duration of follow-up of 35.4 months. Median time from enrollment to data lock was 42 months. In the ITT population, the ORR was 35%, median PFS was 5.6 months (95% CI, 4.6-8.2), and median OS was 15.4 months (CI, 12.4-28.1). There were no statistical differences in PFS or OS by PD-L1 status. The 2- and 3-year landmark OS rates were 33% and 24%, respectively.

conclusionCarboplatin, nab-paclitaxel, and pembrolizumab are a safe and effective regimen for patients with both squamous and nonsquamous NSCLC. Although this study did not meet the prespecified endpoints, the median and landmark OS results are consistent with durable benefit of this regimen as seen in phase III trials for first-line treatment of advanced NSCLC.

Indexed as

Carcinoma, Non-Small-Cell LungCarcinoma, Squamous CellLung NeoplasmsAdultAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinHumansPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCarboplatinPaclitaxelpembrolizumabadenocarcinomacarboplatinimmunotherapylung cancernab-paclitaxelpembrolizumab

Identifiers

PMID37390616
PMCPMC10769801
OpenAlexW4382645579

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.