Who is sponsoring NCT05468489?

NCT05468489 is sponsored by Shanghai Henlius Biotech.

What drugs are being tested in NCT05468489?

Interventions in NCT05468489: Serplulimab + chemotherapy (carboplatin-etoposide), Atezolizumab + chemotherapy (carboplatin-etoposide).

What condition does NCT05468489 study?

NCT05468489 studies Extensive Stage Small Cell Lung Cancer.

Is NCT05468489 still recruiting?

NCT05468489 is currently active, enrolled. Last updated 21 October 2025.

Last reviewed 2025-10-21 · How we verify

NCT05468489

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Active, enrolled Phase 3 Last updated 21 October 2025

What this trial tests

Phase 3 trial testing Serplulimab + chemotherapy (carboplatin-etoposide) in Extensive Stage Small Cell Lung Cancer in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 November 2022

Primary endpoint
28 February 2026

31 December 2027

Quick facts

Lead sponsor	Shanghai Henlius Biotech
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	18 November 2022
Primary completion	28 February 2026
Estimated completion	31 December 2027
Sites	67 locations across United States

Drugs / interventions tested

Serplulimab + chemotherapy (carboplatin-etoposide) — full drug profile →
Atezolizumab + chemotherapy (carboplatin-etoposide) — full drug profile →

Conditions studied

Extensive Stage Small Cell Lung Cancer — all drugs for Extensive Stage Small Cell Lung Cancer →

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

18 and older, any sex, with Extensive Stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging advances in defining the molecular and therapeutic landscape of small-cell lung cancer.
Sen T, Takahashi N, Chakraborty S, Takebe N, et al · · 2024 · cited 79× · PMID 38965396 · DOI 10.1038/s41571-024-00914-x
Emerging Trends in Immunotherapy for Cancer.
Mishra AK, Ali A, Dutta S, Banday S, et al · · 2022 · cited 41× · PMID 36135216 · DOI 10.3390/diseases10030060
First-line serplulimab plus chemotherapy in extensive-stage small-cell lung cancer: Updated results and biomarker analysis from the ASTRUM-005 randomized clinical trial.
Cheng Y, Zhang S, Han L, Wu L, et al · · 2025 · cited 6× · PMID 40440184 · DOI 10.1002/cac2.70032
The efficacy and safety of immunotherapy as first-line treatment for extensive-stage small cell lung cancer: evaluating based on reconstructed individual patient data.
Zhang S, Li S, Cheng Y. · · 2024 · cited 2× · PMID 39026980 · DOI 10.3389/fonc.2024.1371313

Verify or expand the search:

Other recruiting trials for Extensive Stage Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07107490 — A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER · Phase 1 · recruiting
NCT07037758 — A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311 · Phase 1 · recruiting
NCT06598306 — Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) · Phase 1 · recruiting
NCT06502977 — Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines o · Phase 2 · active not recruiting
NCT05361395 — First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage S · Phase 1 · active not recruiting

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05468489 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
Last refreshed: 21 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05468489.

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