A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Titre officiel

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Sommaire:

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:- Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).

Description de l'essai

Primary Outcome:

  • Investigator-Assessed Confirmed Objective Response Rate (ORR)
  • Investigator-Assessed Progression-Free Survival (PFS)
Secondary Outcome:
  • Overall survival (OS)
  • Investigator-Assessed Duration of Response (DOR)
  • Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) as Measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
  • TTCD in Participant-Reported Lung Cancer Symptoms for Cough, Dyspnea, and Chest Pain, as Measured by EORTC QLQ-LC13
  • Percentage of Participants With Adverse Events (AEs)
  • Participants' Response to Side Effects of Treatment as Assessed by EORTC IL46
  • Serum Concentration of Tiragolumab
  • Serum Concentration of Atezolizumab
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
  • Percentage of Participants With ADAs to Atezolizumab

Voir cet essai sur ClinicalTrials.gov

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