Evidence map›Paper›PMID 39755168›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2025

Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03.

Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano and 4 more

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

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03964727 (A Phase 2 Open-Label Study of Sacituzumab Govitecan), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 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.

NCT03964727 phase2active not recruitingnot on this map

A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

TypeinterventionalSponsorGilead SciencesRan2019 to 2026Enrolled227ConditionsMetastatic Solid TumorArmsSacituzumab Govitecan-hziy
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  15. The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Afshin DowlatiUniversity Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, Ohio. Electronic address: Afshin.dowlati@uhhospitals.org.
Anne C ChiangYale School of Medicine, New Haven, Connecticut.
Andrés CervantesINCLIVA Instituto de Investigación Sanitaria, University of Valencia, Valencia, Spain; CIBERONC, Instituto de Salud Carlos III, Madrid, Spain.
Sunil BabuFort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana.
Erika HamiltonSarah Cannon Research Institute, Nashville, Tennessee.
Shu Fen WongAndrew Love Cancer Centre, Geelong, Victoria, Australia.
Andrea TazbirkovaPindara Private Hospital, Benowa, Queensland, Australia.
Ivana Gabriela SullivanHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Cédric van MarckeCliniques universitaires Saint-Luc, Brussels, Belgium.
Antoine ItalianoInstitut Bergonié, Bordeaux, France; University of Bordeaux, Bordeaux, France.
Jilpa PatelGilead Sciences, Inc., Foster City, California.
Sabeen MekanGilead Sciences, Inc., Foster City, California.
Tia WuGilead Sciences, Inc., Foster City, California.
Saiama N WaqarWashington University School of Medicine, St. Louis, Missouri.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive-stage SCLC (ES-SCLC).

methodsTROPiCS-03 (NCT03964727) is a multicohort, open-label, phase 2 basket study of solid tumors, including ES-SCLC. Adults with ES-SCLC that progressed after one previous line of platinum-based chemotherapy and anti-programmed death-(ligand) 1 (PD-[L]1) therapy received SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary end point was the investigator-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary end points included investigator-assessed duration of response (DOR) and progression-free survival (PFS); blinded independent central review-assessed ORR, DOR, and PFS; overall survival (OS); and safety. Efficacy was evaluated in patients with platinum-resistant and platinum-sensitive disease.

resultsAmong 43 patients (median follow-up, 12.3 [range, 8.1-20.1] mo), investigator-assessed ORR was 41.9% (95% confidence interval [CI]: 27.0%-57.9%), with 18 confirmed partial responses; median (95% CI) DOR, PFS, and OS were 4.73 (3.52-6.70), 4.40 (3.81-6.11), and 13.60 (6.57-14.78) months, respectively. The efficacy results of the blinded independent central review assessments were similar. The investigator-assessed ORR (95% CI) was 35.0% (15.4%-59.2%) in patients with platinum-resistant disease (n = 20) and 47.8% (26.8%-69.4%) in patients with platinum-sensitive disease (n = 23). Furthermore, 32 patients (74.4%) had grade greater than or equal to 3 treatment-emergent adverse events (TEAEs). No TEAE led to SG discontinuation; one treatment-related TEAE (neutropenic sepsis) led to death.

conclusionsSG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that observed in other SG studies.

Indexed as

Antibodies, Monoclonal, HumanizedCamptothecinLung NeoplasmsSmall Cell Lung CarcinomaAdultAgedFemaleHumansImmunoconjugatesMaleMiddle AgedSurvival RateAntibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatessacituzumab govitecanAntibody-drug conjugateClinical trialExtensive-stage small cell lung cancerPlatinum sensitivitySacituzumab govitecan

Identifiers

PMID39755168

What OpenQuestion holds

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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.