Evidence map›Paper›PMID 33023530›Full record

Trial reportBMC cancer2020

A phase II study of daily carboplatin plus irradiation followed by durvalumab for stage III non-small cell lung cancer patients with PS 2 up to 74 years old and patients with PS 0 or 1 from 75 years: NEJ039A (trial in progress).

Kyoichi Kaira, Atsuto Mouri, Shingo Kato, Kenichi Yoshimura, Hiroshi Kagamu, Kunihiko Kobayashi

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2020. 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
0.3field-weighted citation impact, top 38% 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, 7 citations in OpenAlex.

  1. Trial
  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

6 authors at 2 institutions in 1 country.

Kyoichi KairaDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan. kkaira1970@yahoo.co.jp.ORCID http://orcid.org/0000-0001-5548-7686
Atsuto MouriDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.
Shingo KatoDepartment of Radiation Oncology, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.
Kenichi YoshimuraCenter for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 732-8551, Japan.
Hiroshi KagamuDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.
Kunihiko KobayashiDepartment of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-City, Saitama, 350-1298, Japan.
Saitama Medical University · JPHiroshima University Hospital · JP

Funding

AstraZeneca company N/A
6 · The paper itself

Abstract

backgroundDurvalumab is a standard drug used during maintenance therapy after chemoradiotherapy in patients with locally advanced non-small cell lung cancer (LA-NSCLC). However, little is known about the clinical benefits of durvalumab after chemoradiotherapy in patients with LA-NSCLC with a performance status (PS) of 2 and/or aged > 75 years. As daily carboplatin plus concurrent thoracic radiotherapy is recommended for elderly patients according to guideline, the current phase II study aims to investigate the effect of daily carboplatin plus radiotherapy followed by durvalumab for patients with stage III NSCLC who have a PS of 2 and/or are older.

methodsDaily carboplatin plus radiotherapy followed by durvalumab is performed for the patients with stage III NSCLC who have a PS of 2 and/or are older. This is a trial in progress manuscript. STUDY TREATMENT: Daily, intravenous, low-dose carboplatin (30 mg/m EXPLORATORY ASSESSMENT: In the future, an exploratory investigation will be performed to determine whether the combined assessment of T-cell markers, PD-L1 expression, and tumor mutation burden could predict the outcomes of the regimen. DISCUSSION: The results of our study will exhibit the efficacy and tolerability of durvalumab as maintenance therapy after daily carboplatin plus radiotherapy.

trial registrationDuring the first registration (before induction chemoradiotherapy), 70 patients will be included; then, we include 58 patients during the second registration (before durvalumab treatment after chemoradiotherapy). https://jcrb.niph.go.jp/ . PRIMARY ENDPOINT: The primary endpoint of the current study is the 12-month progression-free survival (PFS) rate after the initiation of durvalumab. SECONDARY ENDPOINTS: The secondary endpoints are the feasibility, objective response, PFS, overall survival, and adverse events.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungChemoradiotherapyChildChild, PreschoolFemaleHumansInfantInfant, NewbornLung NeoplasmsMaleAntibodies, MonoclonalCarboplatindurvalumabCarboplatinChemoradiotherapyDurvalumabElderlyImmune checkpoint inhibitorLocally advanced non-small cell lung cancerPD-L1 antibodyPS 2

Identifiers

PMID33023530
PMCPMC7542352
OpenAlexW3092177429

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.