SHR-A2009 Combined With Bevacizumab in the Treatment of Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer : a Randomized Controlled, Open, Multicenter Phase III Study
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 in Combination With Bevacizumab Versus Sacituzumab Tirumotecan in Advanced or Metastatic Non-small Cell Lung Cancer
The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Yijing Chen
- Telefonnummer: 0518-82342973
- E-mail: yijing.chen.yc510@hengrui.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- Guangdong Provincial People's Hospital
-
Ledende efterforsker:
- Yilong Wu
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; the age at the time of signing the informed consent form is 18-75 years old ( including both ends ), both men and women can.
The ECOG score was 0 or 1.
-
Participants with locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology.
-
Adequate bone marrow and organ function.
Exclusion Criteria:
- Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy or other unlisted clinical research drugs or treatments were received within 4 weeks before the first medication.
- Untreated or active central nervous system tumor metastasis
- Imaging showed that the tumor invaded important organs or tumor surrounding / invasion of large blood vessels or there was obvious necrosis / cavity, which was judged by the researchers to have a risk of bleeding.
- History of interstitial pneumonia or participants who cannot rule out interstitial pneumonia ; or other moderate to severe lung diseases ; or received previous pneumonectomy surgery
- Participants with severe cardiovascular and cerebrovascular diseases
- Have a history of severe bleeding tendency or coagulation dysfunction ; bleeding symptoms with significant clinical significance occurred within 3 months before the first medication.
- Arterial and venous thrombosis events occurred within 6 months before the first administration ;
- HIV test positive
- Participants with active hepatitis B or C
- Severe infection occurred within 4 weeks before the first administration
- Allergy to any component of the treatment regimen
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: SHR-A2009 + bevacizumab
|
SHR-A2009 + bevacizumab |
|
Aktiv komparator: Sacituzumab Tirumotecan
|
Sacituzumab Tirumotecan |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
PFS
Tidsramme: about 24 months
|
about 24 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The incidence and grade of adverse events;
Tidsramme: about 24 months
|
about 24 months
|
|
OS
Tidsramme: about 24 months
|
about 24 months
|
|
ORR
Tidsramme: about 24 months
|
about 24 months
|
|
DoR
Tidsramme: about 24 months
|
about 24 months
|
|
DCR
Tidsramme: about 24 months
|
about 24 months
|
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- SHR-A2009-303
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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