Evidence map›Paper›PMID 42334618›Full record

Trial reportCancer immunology, immunotherapy : CII2026

Phase II study of 1st-line durvalumab and platinum-etoposide in advanced large-cell neuroendocrine lung carcinoma (aLCNEC).

Elizabeth Dudnik, Hovav Nechushtan, Ofer Rotem, Ekaterina Hanovich, Mira Wollner, Tatiana Boikaner, Niel Fridman, Jonathan Ofer, Merav A Ben-David, Daniel Reinhorn

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Elizabeth DudnikThoracic Oncology, Assuta Medical Centers, 20 HaBarzel Street, Ramat HaHayal, 6971028, Tel Aviv, Israel. elizabethd@assuta.co.il.
Hovav NechushtanSharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Ein Kerem Campus, P.O.B. 12000, 91120, Jerusalem, Israel.
Ofer RotemDavidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 39 Jabotinsky Street, 4941492, Petah Tikva, Israel.
Ekaterina HanovichDavidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 39 Jabotinsky Street, 4941492, Petah Tikva, Israel.
Mira WollnerInstitute of Oncology, Rambam Medical Centre, 8 HaAliyah HaShniya Street, Bat Galim, 3109601, Haifa, Israel.
Tatiana BoikanerSanz Medical Center, Laniado Hospital, 6 Divrei Haim Street, 4244916, Netanya, Israel.
Niel FridmanSanz Medical Center, Laniado Hospital, 6 Divrei Haim Street, 4244916, Netanya, Israel.
Jonathan OferDavidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 39 Jabotinsky Street, 4941492, Petah Tikva, Israel.
Merav A Ben-DavidFaculty of Health Sciences, Joyce & Irving Goldman Medical School, Ben Gurion University of the Negev, P.O.B. 653, 84105, Beer-Sheva, Israel.
Daniel ReinhornDavidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, 39 Jabotinsky Street, 4941492, Petah Tikva, Israel.

Funding

Astra Zeneca This investigator-initiated trial was funded by AstraZeneca as an externally funded research (funding provided to the participating center).
6 · The paper itself

Abstract

backgroundLCNEC is a rare high-grade neuroendocrine malignancy with poor prognosis and limited evidence to guide systemic therapy.

methodsProspective, single-arm phase II study of 1st-line durvalumab 1500 mg + cisplatin or carboplatin and etoposide (EP) q3 weeks for 4 cycles, followed by durvalumab 1500 mg q4 weeks, in aLCNEC. The primary endpoint was 12-month PFS (RECIST v1.1, radiologist-assessed); secondary endpoints were ORR, OS, and safety. Sample size followed a single-stage Fleming design (one-sided α = 0.10, power 80%) testing a 12-month PFS rate ≤ 5% (H0) vs ≥ 18% (H1). The study closed early due to slow accrual after twelve of twenty-two planned patients were enrolled.

resultsTwelve patients were treated (median age 68y; 66.7% male; 91.7% smokers; 91.7% stage IVB). After median follow-up of 12.8 months (95% CI 8.5-21.3), 92% had progressed and 75% had died. Median PFS was 4.4 months (95% CI 3.1-12.9); 12-month PFS was 25.0% (95% CI 6.0-50.5), exceeding the ≤ 5% null hypothesis (H0) and compatible with the ≥ 18% target (H1). Median OS was 12.8 months (95% CI 5.2-NR); 12-month OS was 58.3% (95% CI 27.0-80.1). ORR was 50.0%, and DCR was 91.7%. All three patients with untreated brain metastases achieved complete intracranial response. Toxicities were mainly grade 1-2; 41.7% had grade 3 adverse events; three discontinued durvalumab for immune-related toxicity; and no treatment-related deaths occurred.

conclusionsThis first prospective evaluation of durvalumab + EP in aLCNEC, though underpowered, demonstrates efficacy and safety consistent with design expectations.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Large CellCarcinoma, NeuroendocrineLung NeoplasmsAgedCarboplatinCisplatinEtoposideFemaleHumansMaleMiddle AgedProspective StudiesAntibodies, MonoclonalCarboplatinCisplatindurvalumabEtoposideCarcinomaImmune checkpoint inhibitorsImmunotherapyLCNECNeuroendocrinePD-L1 inhibitors

Identifiers

PMID42334618
PMCPMC13578167

What OpenQuestion holds

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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.