Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) : A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment..
Medienart: |
Klinische Studie |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
ClinicalTrials.gov - (2024) vom: 23. Jan. Zur Gesamtaufnahme - year:2024 |
---|
Sprache: |
Englisch |
---|
Links: |
Volltext [kostenfrei] |
---|
Themen: |
610 |
---|
Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: May 7, 2020, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2024, Last updated: January 31, 2024 |
---|
Study ID: |
NCT04379635 |
---|---|
Veröffentlichungen zur Studie: |
|
fisyears: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
CTG003385108 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | CTG003385108 | ||
003 | DE-627 | ||
005 | 20240131010520.0 | ||
007 | cr uuu---uuuuu | ||
008 | 210408s2024 xx |||||o 00| ||eng c | ||
035 | |a (DE-627)CTG003385108 | ||
035 | |a (UBBS_Klinische_Studien)NCT04379635 | ||
035 | |a (UBBS_Klinische_Studien)BGB-A317-315 | ||
035 | |a (UBBS_Klinische_Studien)CTR20200821 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
245 | 1 | 0 | |a Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) |b A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: May 7, 2020, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2024, Last updated: January 31, 2024 | ||
520 | |a The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. | ||
650 | 2 | |a Lung Neoplasms | |
650 | 2 | |a Carcinoma, Non-Small-Cell Lung | |
650 | 4 | |a Study Type: Interventional | |
650 | 4 | |a Recruitment Status: Active, not recruiting | |
650 | 4 | |a Phase: Phase 3 | |
650 | 4 | |a 610 | |
773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 23. Jan. |
773 | 1 | 8 | |g year:2024 |g day:23 |g month:01 |
856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04379635 |z kostenfrei |3 Volltext |
912 | |a GBV_CTG | ||
951 | |a AR | ||
952 | |j 2024 |b 23 |c 01 |