Evidence map›Paper›PMID 40025391›Full record

Trial reportAdvances in therapy2025

Patient-Reported Outcomes for Patients with Previously Treated Small Cell Lung Cancer Receiving Tarlatamab: Results from the DeLLphi-301 Phase 2 Trial.

Horst-Dieter Hummel, Myung-Ju Ahn, Fiona Blackhall, Martin Reck, Hiroaki Akamatsu, Suresh S Ramalingam, Hossein Borghaei, Melissa Johnson, Franziska Dirnberger, Kim Cocks and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05060016 (A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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.

NCT05060016 phase2active not recruitingnot on this map

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

TypeinterventionalSponsorAmgenRan2021 to 2027Enrolled222ConditionsRelapsed/Refractory Small Cell Lung CancerArmsTarlatamab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Dermatologic Adverse Events Associated with T-Cell Engager Therapy.American journal of clinical dermatology · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. 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

13 authors.

Horst-Dieter HummelTranslational Oncology/Early Clinical Trial Unit (ECTU), Bavarian Cancer Research Center, National Center for Tumor Diseases, Comprehensive Cancer Center Mainfranken and University Hospital Würzburg, Haus A9, Ebene 2, Straubmühlweg 2a, 97078, Würzburg, Germany. hummel_h@ukw.de.ORCID 0009-0006-2634-9747
Myung-Ju AhnSection of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Fiona BlackhallChristie NHS Foundation Trust and University of Manchester, Manchester, UK.ORCID 0000-0001-8716-3395
Martin ReckLungenClinic, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Großhansdorf, Germany.ORCID 0000-0002-5336-9739
Hiroaki AkamatsuWakayama Medical University Hospital, Wakayama, Japan.ORCID 0000-0001-5856-5512
Suresh S RamalingamWinship Cancer Institute of Emory University, Atlanta, USA.ORCID 0000-0002-0757-3106
Hossein BorghaeiFox Chase Cancer Center, Philadelphia, PA, USA.ORCID 0000-0002-2577-4454
Melissa JohnsonSarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA.ORCID 0000-0001-9874-1314
Franziska DirnbergerAmgen GmbH, Munich, Germany.
Kim CocksAdelphi Values Ltd, Patient-Centered Outcomes, Bollington, Cheshire, UK.ORCID 0000-0003-2595-708X
Shuang HuangAmgen, Inc., Thousand Oaks, CA, USA.
Sujoy MukherjeeAmgen, Inc., Thousand Oaks, CA, USA.
Luis Paz-AresHospital Universitario 12 de Octubre, CNIO-H120 Lung Cancer Unit, Complutense University and Ciberonc, Madrid, Spain.ORCID 0000-0002-1947-3364

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTarlatamab demonstrated a durable response and promising survival outcomes in patients with previously treated small cell lung cancer (SCLC) in the phase 2, open-label DeLLphi-301 trial. Patient-reported outcomes (PROs) were evaluated to assess the benefit-risk profile of tarlatamab.

methodsPatients received tarlatamab intravenously every 2 weeks at a dose of 10 mg (regulatory approved dose) or 100-mg until progression or loss of benefit. PROs, including European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC-QLQ-C30) and 13-item lung cancer module (LC13), Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and the GP5 question of the Functional Assessment of Cancer Therapy - General Form (FACT-GP5), were collected at Cycle 1 (days 1, 8, 22), Cycle 2 (days 1, 15) and every 6 weeks from Cycle 3 onwards. PROs were summarized descriptively alongside the amount and reason for missing data and analyzed using a mixed model for repeated measures. In addition, median time to deterioration (TTD) for symptom and functional scales was analyzed.

resultsA total of 100 patients were PRO-evaluable at the selected target dose (10 mg). EORTC-QLQ-C30 and LC13 completion rates (proportion of PRO assessments expected to be completed) were high (> 80%) throughout the study. Least square mean changes from baseline showed a trend towards improvement for the QLQ-C30 subscale of global health status and stabilization for physical functioning. Patients experienced reduced symptom burden for dyspnea which was more pronounced for patients at later cycles (≥ 10 points), and stabilization for chest pain and cough. Median TTD exceeded 6 months for cough and dyspnea and was not estimable for chest pain. Overall, tarlatamab was well tolerated with the majority of patients reporting no bother or a little bit of bother from side effects post baseline. Patient-reported adverse events were generally of mild to moderate severity occurring rarely or occasionally.

conclusionAlongside previously reported antitumor activity, tarlatamab demonstrated a positive benefit-risk profile in previously treated SCLC with favorable PROs across a range of functional outcomes and symptoms, while showing manageable and sustained tolerability. CLINICALTRIALS: GOV NUMBER: NCT05060016.

Indexed as

Antineoplastic AgentsLung NeoplasmsPatient Reported Outcome MeasuresSmall Cell Lung CarcinomaAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeAntineoplastic AgentsDeLLphi-301Patient reported outcomesPhase 2 trialSmall cell lung cancerTarlatamab

Identifiers

PMID40025391
PMCPMC11929685

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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.