Trial results for the Phase 2 study (NCT04832854) investigating atezolizumab plus tiragolumab in participants with locally advanced resectable non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2026-03-11. The study reported a major pathological response (MPR) rate of 71.4% in the PD-L1 High cohort. The trial, which was terminated, also provided data on surgical safety and adverse events.
Background
This study evaluated atezolizumab plus tiragolumab, with or without platinum-based chemotherapy, as neoadjuvant and adjuvant treatment for participants with previously untreated locally advanced resectable Stage II, IIIA, or select IIIB Non-Small Cell Lung Cancer (NSCLC).
Trial design
The study NCT04832854 was a Phase 2 trial that enrolled 50 participants with previously untreated locally advanced resectable Stage II, IIIA, or select IIIB Non-Small Cell Lung Cancer (NSCLC). The trial investigated atezolizumab plus tiragolumab, alone or in combination with platinum-based chemotherapy, as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy. Participants were stratified into Cohort A: PD-L1 High and Cohort B: PD-L1 All Comers.
Key results
The trial reported the following key measurements:
- Major Pathological Response (MPR) Rate: 71.4% of participants in Cohort A: PD-L1 High achieved MPR, compared to 51.2% in Cohort B: PD-L1 All Comers.
- Number of Participants With Surgical Delays: 0 participants in Cohort A: PD-L1 High experienced surgical delays, while 4 participants in Cohort B: PD-L1 All Comers did.
- Number of Participants With Operative and Post-operative Complications: In Cohort A: PD-L1 High, 0 participants were reported with complications in one measurement, and 2 participants in another. In Cohort B: PD-L1 All Comers, 3 participants were reported with complications in one measurement, and 7 participants in another.
- Number of Participants With Surgical Cancellations Related to Study Treatment: 0 participants in both Cohort A: PD-L1 High and Cohort B: PD-L1 All Comers experienced surgical cancellations.
- Number of Participants With Adverse Events (AEs): 7 participants in Cohort A: PD-L1 High experienced AEs, compared to 41 participants in Cohort B: PD-L1 All Comers.
What this means
The results from this Phase 2 trial provide initial insights into the efficacy and safety of atezolizumab plus tiragolumab, with or without chemotherapy, as neoadjuvant and adjuvant treatment for locally advanced resectable NSCLC. The observed major pathological response rates, particularly the 71.4% in the PD-L1 High cohort, suggest potential anti-tumor activity. The data on surgical delays, complications, and cancellations, along with adverse events, offers important information regarding the surgical feasibility and tolerability of this regimen in the neoadjuvant setting. The termination of the trial indicates that further development may be impacted, but the posted results contribute to the understanding of these agents in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04832854, titled "A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer," were posted on 2026-03-11 on clinicaltrials.gov.