A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
A Randomized, Open-Label, Multicenter Phase III Trial of HRS-7058 Versus the Investigator-Selected KRAS G12C Inhibitor in KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Sida Zhu
- Telefonnummer: +86-18611089618
- E-mail: sida.zhu.sz15@hengrui.com
Undersøgelse Kontakt Backup
- Navn: Han Xu
- Telefonnummer: +86-17721286653
- E-mail: Han.xu@hengrui.com
Studiesteder
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute and Hospital
-
Ledende efterforsker:
- Dingzhi Huang
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 years old to 75 years old ( including both ends ), regardless of gender ;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ;
- Histological specimens confirmed the presence of KRAS G12 C mutation ;
- Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ;
- At least one measurable lesion conforming to the definition of RECIST v1.1 standard ;
- ECOG physical score 0-1 points ;
- Expected survival time ≥ 12 weeks ;
- Have adequate bone marrow and organ function
- Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form.
Exclusion Criteria:
- Subjects with active central nervous system ( CNS ) metastasis ;
- Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection.
- Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ;
- Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ;
- Have serious cardiovascular and cerebrovascular diseases
- Severe infection occurred within 4 weeks before the first administration.
- The first study of arterial / venous thrombosis events within 3 months before medication was conducted.
- Have a history of immunodeficiency, including HIV test positive ;
- There is active hepatitis B or hepatitis C ;
- Subjects with active central nervous system ( CNS ) metastasis ;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Treatment group A: HRS-7058
|
HRS-7058
|
|
Aktiv komparator: Treatment group B: Fulzerasib Tablets
|
600mg BID
|
|
Aktiv komparator: Treatment group C: Garsorasib Tablets
|
600mg BID
|
|
Aktiv komparator: Treatment group D: Glecirasib Citrate Tablets
|
800mg QD
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
PFS based on BICR evaluation
Tidsramme: about 32 months
|
about 32 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
OS
Tidsramme: about 45 months
|
about 45 months
|
|
PFS based on researcher 's assessment
Tidsramme: about 32 months
|
about 32 months
|
|
ORR based on researchers and BICR assessment
Tidsramme: about 45 months
|
about 45 months
|
|
DoR based on researchers and BICR evaluation
Tidsramme: about 45 months
|
about 45 months
|
|
DCR based on researcher and BICR assessment
Tidsramme: about 45 months
|
about 45 months
|
|
The incidence and severity of adverse events ( AE )
Tidsramme: about 45 months
|
about 45 months
|
|
the occurrence of severe adverse events ( SAE )
Tidsramme: about 45months
|
about 45months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS-7058-301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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