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A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

25. juni 2026 opdateret af: CSPC Megalith Biopharmaceutical Co.,Ltd.

A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.

The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, open-label, multicenter, Phase III clinical study. Participants with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

570

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Clinical Trials Information Group officer
  • Telefonnummer: 031169085587
  • E-mail: ctr-contact@cspc.cn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Able to understand and willingness to voluntarily provide written informed consent.
  2. Age 18 to 75 years, males or females.
  3. Histologically confirmed squamous or non-squamous NSCLC.
  4. Ability to provide qualified tumor samples.
  5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.
  6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).
  7. The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).

Exclusion Criteria:

  1. Participants with a condition requiring further surgical resection, in the investigator's opinion.
  2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
  3. Eligible only for incomplete resection.
  4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
  5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.
  6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SYS6010 + Enlonstobart
Medicin: SYS6010
SYS6010
Medicin: Enlonstobart
Enlonstobart
Andre navne:
  • SG001
Aktiv komparator: Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen
Medicin: Nivolumab
Nivolumab
Andre navne:
  • Opdivo, BMS936558S
Medicin: Pembrolizumab
Pembrolizumab
Andre navne:
  • KEYTRUDA® MK-3475
Medicin: Durvalumab
Durvalumab
Andre navne:
  • MEDI4736
Medicin: Tislelizumab
administreres via intravenøs (IV) injektion
Andre navne:
  • BGB-A317
Medicin: Toripalimab ±+platinum-based doublet chemotherapy
Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
Andre navne:
  • Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-Free Survival (DFS) assessed by the independent review committee (IRC)
Tidsramme: Up to approximately 60 months
DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.
Up to approximately 60 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Up to approximately 60 months
OS was defined as the time from randomization to the date of death(whatever the cause).
Up to approximately 60 months
DFS assessed by investigators
Tidsramme: Up to approximately 60 months
DFS was defined as the time from randomization to either the date of disease recurrence as assessed by investigators per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.
Up to approximately 60 months
Incidence and severity of Adverse Events (AEs)
Tidsramme: Approximately 15 months
Approximately 15 months
EORTC QLQ-30 questionnaire
Tidsramme: Approximately 13 months
Approximately 13 months
Blood concentration of SYS6010 and Enlonstobart
Tidsramme: Approximately 13 months
Approximately 13 months
Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Tidsramme: Approximately 13 months
Approximately 13 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

30. september 2029

Studieafslutning (Anslået)

30. november 2031

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SYS6010-015

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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