Evidence map›Paper›PMID 36076179›Full record

Trial reportBMC cancer2022

Phase II study of carboplatin/nab-paclitaxel/atezolizumab combination therapy for advanced nonsquamous non-small cell lung cancer patients with impaired renal function: RESTART trial.

Yoshimasa Shiraishi, Junji Kishimoto, Takayuki Shimose, Yukihiro Toi, Shunichi Sugawara, Isamu Okamoto

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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 3 institutions in 1 country.

Yoshimasa ShiraishiDepartment of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Junji KishimotoDepartment of Research and Development of Next Generation Medicine, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Takayuki ShimoseDepartment of Statistics and Data Center, Clinical Research Support Center Kyushu, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Yukihiro ToiDepartment of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirose-machi, Sendai, Miyagi, 980-0873, Japan.
Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, 4-15 Hirose-machi, Sendai, Miyagi, 980-0873, Japan.
Isamu OkamotoDepartment of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. okamoto.isamu.290@m.kyushu-u.ac.jp.
Kyushu University · JPSendai Kousei Hospital · JPKyushu Economic Research Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst-line treatment of nonsquamous non-small cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with immune checkpoint inhibitors (ICIs). However, phase III studies of combinations of cytotoxic chemotherapy and ICIs have included only patients with maintained organ function, not those with renal impairment.

methodsCytotoxic chemotherapy-naïve advanced nonsquamous NSCLC patients aged 20 years or older with impaired renal function (creatinine clearance of 15 to 45 mL/min) are prospectively registered in this single-arm phase II study and receive combination therapy with carboplatin, nanoparticle albumin-bound (nab-) paclitaxel, and atezolizumab. Individuals with known genetic driver alterations including those affecting EGFR, ALK, ROS1, BRAF, MET, RET, and NTRK are excluded. We plan to enroll 40 patients over 2 years at 32 oncology facilities in Japan. The primary end point is confirmed objective response rate. DISCUSSION: If the study demonstrates efficacy and safety of carboplatin/nab-paclitaxel/atezolizumab, then this combination regimen may become a treatment option even for nonsquamous NSCLC patients with impaired renal function.

trial registrationRegistered with Japan Registry for Clinical Trials on 25 February 2021 (jRCTs071200102).

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsRenal InsufficiencyAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinHumansKidneyPaclitaxelProtein-Tyrosine KinasesProto-Oncogene Proteins130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedatezolizumabCarboplatinPaclitaxelProtein-Tyrosine KinasesProto-Oncogene ProteinsChemotherapyClinical trialImmune checkpoint inhibitorNonsquamous non–small cell lung cancerRenal impairment

Identifiers

PMID36076179
PMCPMC9461146
OpenAlexW4295084876

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.