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A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

11. september 2026 opdateret af: Jiangsu Hansoh Pharmaceutical Co., Ltd.

A Randomized, Open-label, Controlled, Multicenter Phase 3 Trial of HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation.

This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as first-line treatment in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

448

Fase

  • Fase 3

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:

  • Participants are able to comply with the process of the protocol.
  • Men or women greater than or equal to 18 years
  • At least one measurable lesion in accordance with RECIST 1.1
  • Must have an ECOG performance status of 0 or 1.
  • Must have adequate laboratory parameters.
  • Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
  • Documentation of the presence of a KRAS G12C mutation
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.

Exclusion Criteria:

  • Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
  • Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
  • Active brain metastases.
  • Participants with uncontrolled pleural, ascites or pericardial effusion
  • History of other primary malignancies.
  • Abnormal cardiac examination results.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Uncontrolled hypertension.
  • Severe bleeding symptoms or bleeding tendencies.
  • Severe arteriovenous thrombosis occurred
  • Serious infection.
  • Continuous use of glucocorticoids
  • Active infectious diseases.
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  • Interstitial lung disease (ILD).
  • Serious neurological or mental disorders.
  • Active autoimmune diseases.

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: Arm A: HS-10370 plus Adebrelimab plus chemotherapy
Indgives intravenøst
Indgives intravenøst
Indgives intravenøst
Administered orally.
Administered intravenously
Aktiv komparator: Arm B: Tislelizumab plus chemotherapy
Indgives intravenøst
Indgives intravenøst
Indgives intravenøst
Indgives intravenøst
Andet: Arm C: HS-10370 plus chemotherapy
Indgives intravenøst
Indgives intravenøst
Administered orally.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Progression-Free Survival (PFS) PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Overall Survival (OS)
Tidsramme: Randomization to date of death from any cause. (Estimated as up to 3 years)
OS
Randomization to date of death from any cause. (Estimated as up to 3 years)
Overall Response Rate (ORR)
Tidsramme: Randomization to disease progression or death. (Estimated as approximately 1 year)
ORR per RECIST v1.1 by BICR and Investigator
Randomization to disease progression or death. (Estimated as approximately 1 year)
Duration of Response (DOR)
Tidsramme: Randomization to disease progression or death. (Estimated as approximately 1 year)
DOR per RECIST v1.1 by BICR and Investigator
Randomization to disease progression or death. (Estimated as approximately 1 year)
Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Tidsramme: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Number of Participants with a TEAE
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)

Samarbejdspartnere og efterforskere

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

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)

31. oktober 2026

Primær færdiggørelse (Anslået)

31. maj 2030

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

11. september 2026

Først indsendt, der opfyldte QC-kriterier

11. september 2026

Først opslået (Faktiske)

16. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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