Clinical Trials Logo
  1. Home
  2. Non-small Cell Lung Cancer NSCLC
  3. NCT05791097

Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC. — AdvanTIG-306  

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:
AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Summary

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

Clinical Trial Description

This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy as first-line treatment for participants with locally advanced or metastatic NSCLC without actionable driver mutations. Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05791097
Study type Interventional
Source Novartis
Contact
Status Withdrawn
Phase Phase 3
Start date July 28, 2023
Completion date December 26, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT03667820 - Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Phase 2
Completed NCT02025114 - Selumetinib in Combination With Gefitinib in NSCLC Patients Phase 1/Phase 2
Recruiting NCT01994057 - A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
Completed NCT01438307 - Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer Phase 2
Completed NCT01193959 - Pemetrexed in Advanced Non-small Cell Lung Cancer
Recruiting NCT01028729 - A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) Phase 4
Completed NCT00770588 - Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) Phase 4
Active, not recruiting NCT05462717 - Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Phase 1
Completed NCT01951157 - A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients Phase 2
Recruiting NCT01964157 - An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement Phase 2
Active, not recruiting NCT04026412 - A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery Phase 3
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT03260491 - HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer Phase 1
Completed NCT05207423 - A Chart Review Study of Adults With Advanced NSCLC
Terminated NCT02608528 - Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
Completed NCT01463423 - Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR) N/A
Recruiting NCT02927340 - A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Phase 2
Recruiting NCT02521051 - Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer Phase 1/Phase 2