| Primary | Number of Participants With Surgical Delays | 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). | Safety-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to approximately 4.7 months | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Participants With Operative and Post-operative Complications | Participants who underwent surgical resection of their tumor and had intraoperative or post-operative complications were reported. | Safety-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | From day of surgery up to end of safety follow-up (up to approximately 17.5 months) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Primary | Number of Participants With Surgical Cancellations Related to Study Treatment | 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. | Safety-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to approximately 4.7 months | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Primary | Number of Participants With Adverse Events (AEs) | 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. | Safety-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | From signing of informed consent to up to 90 days after the final dose of study treatment (Up to approximately 1.7 years) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. |
|
| Primary | Major Pathological Response (MPR) Rate | 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. | Efficacy-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At the time of surgical resection (From Day 114 to Day 144) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Secondary | Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined as the absence of any viable tumor cells in both the primary tumor and all sampled lymph nodes at the time of surgical resection, as assessed by local pathology laboratory. 95% CI was calculated using the Wilson Score Method. Percentages have been rounded off. | Efficacy-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At the time of surgical resection (From Day 114 to Day 144) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Secondary | Event-free Survival (EFS) | EFS was defined as the time from first dose of the study drug to any of the following events, whichever occurs first: disease progression that precludes surgery, as assessed by the investigator; local or distant disease recurrence (including occurrence of new primary NSCLC); or death from any cause. Median was estimated using Kaplan-Meier (K-M) method. 95% CI for median was computed using the method of Brookmeyer and Crowley. | Efficacy-evaluable population included all enrolled participants who received at least one dose of study treatment. | Posted | | Median | 95% Confidence Interval | months | | Up to approximately 3.8 years | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Secondary | Serum Concentrations of Atezolizumab at Specified Timepoints | | Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of study treatment (tiragolumab or atezolizumab) and had at least one evaluable post-dose PK sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | | Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12, and 16; 30 minutes (min) post-infusion Day 1 of Cycle 1; (Cycle=21 days) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Secondary | Serum Concentrations of Tiragolumab at Specified Timepoints | | PK-evaluable population included all participants who received at least one dose of study treatment (tiragolumab or atezolizumab) and had at least one evaluable post-dose PK sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Prior to the first infusion on Day 1 of Cycles 1, 2, 3, 4, 5, 8, 12, 16; 30 minutes (min) post-infusion Cycle 1 Day 1; (Cycle=21 days) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|
| Secondary | Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off. | Immunogenicity-analysis population included all participants with any ADA assessments, with patients grouped according to treatment received. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | | Number | | percentage of participants | | Up to approximately 3.8 years | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | |
|
| Secondary | Percentage of Participants With ADAs to Tiragolumab | Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded off. | Immunogenicity-analysis population included all participants with any ADA assessments, with patients grouped according to treatment received. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | | Number | | percentage of participants | | Up to approximately 3.8 years | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: PD-L1 High | Participants with tumors having high PD-L1 expression received neoadjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles, or adjuvant platinum-based chemotherapy (per investigator's choice) for 4 cycles or until unacceptable toxicity, disease recurrence, withdrawal, or death due to any cause. | | OG001 | Cohort B: PD-L1 All Comers | Participants with tumors, regardless of levels of PD-L1 expression received neo-adjuvant treatment with atezolizumab, 1200 mg, IV, plus tiragolumab, 600 mg, IV, on Day 1 of each 21-day cycle for 4 cycles, along with platinum-based chemotherapy for 4 cycles, followed by surgical resection. Participants then received adjuvant atezolizumab, 1200 mg, IV, in combination with tiragolumab, 600 mg, IV on Day 1 of each 21-day cycle for 16 cycles or until unacceptable toxicity, disease recurrence, withdrawal or death due to any cause. |
|