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

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

ClinicalTrials.gov ID

NCT04832854

Acronym / sponsor ID

GO42501

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Study was terminated as data became available from Phase 3 trials of perioperative regimens combining chemotherapy with immunotherapy showing improved efficacy outcomes versus chemotherapy alone.

Enrolment

50 participants (actual)

Lead sponsor

Hoffmann-La RocheIndustry (pharma, biotech, devices)

Study start

23 Apr 2021 (actual)

Primary completion

5 Mar 2025 (actual)

Study completion

5 Mar 2025 (actual)

First posted

6 Apr 2021 (actual)

Results

Posted 11 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Surgical Delays

   Time frame: Up to approximately 4.7 months

   Participants were scheduled to undergo surgical resection of their tumor upon completion of four cycles of neo-adjuvant therapy. Prior to the surgery, the attending surgeon and medical oncologist assessed the participant to check if it was clinically feasible for them to undergo surgery (pre-surgical assessment). Surgery was to be done within 30 days of the pre-surgical assessment visit. Assessment of surgical delays were made by assessing the data entered in the electronic case report forms (eCRFs).

2. Number of Participants With Operative and Post-operative Complications

   Time frame: From day of surgery up to end of safety follow-up (up to approximately 17.5 months)

   Participants who underwent surgical resection of their tumor and had intraoperative or post-operative complications were reported.

3. Number of Participants With Surgical Cancellations Related to Study Treatment

   Time frame: Up to approximately 4.7 months

   Participants were scheduled to undergo surgical resection of their tumor upon completion of four cycles of neo-adjuvant therapy. Prior to the surgery, the attending surgeon and medical oncologist assessed the participant for to check if it was clinically feasible for them to undergo surgery (pre-surgical assessment). Surgery was to be done within 30 days of the pre-surgical assessment visit. Assessment of surgical delays were made by assessing the data entered in the eCRFs.

4. Number of Participants With Adverse Events (AEs)

   Time frame: From signing of informed consent to up to 90 days after the final dose of study treatment (Up to approximately 1.7 years)

   AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; Any new disease or exacerbation of an existing disease; Recurrence of an intermittent medical condition not present at baseline; Any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study treatment; AEs that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.

5. Major Pathological Response (MPR) Rate

   Time frame: At the time of surgical resection (From Day 114 to Day 144)

   MPR rate was defined as the percentage of participants who achieved MPR. MPR was defined as ≤10% residual viable tumor at the time of surgical resection in the primary tumor, as assessed by the local pathology laboratory. Patients who did not proceed to surgery were considered as non-responders for MPR. 95% confidence interval (CI) was calculated using the Wilson Score Method. Percentages have been rounded off.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Related trials for Non-Small Cell Lung Cancer (NSCLC)

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• RecruitingObservational study

  A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC

  Non Small Cell Lung Cancer

• RecruitingPhase 3

  A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

  Non-Small Cell Lung Cancer (NSCLC)

• Active, not recruitingPhase 2

  Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

  Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

• Not yet recruitingPhase 1/2

  STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

  NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

21 sites in 5 countries: see every site and its status.