| Primary | Overall Survival (OS) | OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | The FAS included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022] | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00014.6(12.2 to 16.9)
- OG00112.8(10.1 to 14.7)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Stratified Log-rank test | | 0.037 | | Hazard Ratio (HR) | 0.84 | | | 2-Sided | 95 | 0.706 | 0.989 | | | The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model | | Other | The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus >= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs. non-squamous + former/current smoker) and using the rank tests of association approach. | |
|
| Primary | OS in Participants With LREM | OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS in PD-L1 TC >= 50% Analysis Set | OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS in PD-L1 TC >= 50% LREM Analysis Set | OS is defined as the time from the date of randomization until death due to ay cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 o 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | The PFS (per RECIST 1.1) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). Progression of disease per RECIST 1.1, when either 1 of the criteria met: Target lesion (TL): at least a 20% increase in the sum of diameters of TLs, for reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Non-target lesion (NTL): Unequivocal progression of existing NTLs. It may be due to an important progression in 1 lesion only or in several lesions. In all cases the progression must be clinically significant for the physician to consider changing (or stopping) therapy. New lesions: the presence of 1 or more new lesions was assessed as progression. | The FAS included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. |
|
| Secondary | PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set | The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set | The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set | The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment | ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs). Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. | The FAS included all randomized participants who had PD-L1 expression TC >= 25% with the VENTANA PD-L1 (SP263) assay. | Posted | | Number | | percentage of participants | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set | ORR (per RECIST 1.1 using Investigator assessments)was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | | percentage of participants | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set | ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Number | | percentage of participants | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set | ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | | percentage of participants | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 o 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 o 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set | DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Alive and Progression-Free at 12 Months (APF12) | The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. | The FAS included all randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization until 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
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| Secondary | APF12 in PD-L1 TC >= 25% LREM Analysis Set | The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization until 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | APF12 in PD-L1 TC >= 50% Analysis Set | The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization until 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | APF12 in PD-L1 TC >= 50% LREM Analysis Set | The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization until 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Time From Randomization to Second Progression (PFS2) | PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants who had PD-L1 expression TC >= 25% with the VENTANA PD-L1 (SP263) assay. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | PFS2 in PD-L1 TC >= 25% LREM Analysis Set | PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | PFS2 in PD-L1 TC >= 50% Analysis Set | PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | PFS2 in PD-L1 TC >= 50% LREM Analysis Set | PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Median | 95% Confidence Interval | months | | Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 18 Months | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. | The FAS included all randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 18 months. | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 18 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 18 Months in PD-L1 TC >= 50% Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 18 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 18 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 24 Months | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. | The FAS included all randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 24 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 24 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 24 Months in PD-L1 TC >= 50% Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. | The PD-L1 TC >= 50% analysis set included the subset of participants in the FAS whose PD-L1 expression status was PD-L1 TC >= 50% as defined by the VENTANA PD-L1 (SP263) assay. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 24 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set | OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months. | The PD-L1 TC >= 50% LREM analysis set included participants with PD-L1 TC >= 50% and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From date of randomization till 24 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30) | The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. | The FAS included all randomized participants. | Posted | | Mean | Standard Error | scores on a scale | | Baseline and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
|
| Secondary | Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set | The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. Only data from the participants analyzed were reported. | Posted | | Mean | Standard Error | scores on a scale | | Baseline and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
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| Secondary | Time to Deterioration of EORTC QLQ-C30 | Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration (a decrease in the function scales or the global health status/ health-related quality of life [HRQoL] from baseline of ≥10) that was confirmed at a subsequent visit or death in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. | The FAS included all randomized participants. Only data from the participants analyzed were reported. | Posted | | Median | 95% Confidence Interval | months | | From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC |
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| Secondary | Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set | Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. Only data from the participants analyzed were reported. | Posted | | Median | 95% Confidence Interval | months | | From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 |
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| Secondary | Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13) | The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. | The FAS included all randomized participants. Only data from the participants analyzed were reported. | Posted | | Mean | Standard Error | scores on a scale | | Baseline and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
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| Secondary | Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set | The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. Only data from the participants analyzed were reported. | Posted | | Mean | Standard Error | scores on a scale | | Baseline and 12 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
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| Secondary | Time to Deterioration of EORTC QLQ-LC13 | Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. | The FAS included all randomized participants. Only data from the participants analyzed were reported. | Posted | | Median | 95% Confidence Interval | months | | From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
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| Secondary | Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set | Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of ≥10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. Only data from the participants analyzed were reported. | Posted | | Median | 95% Confidence Interval | months | | From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022) | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. | The FAS included all randomized participants. | Posted | | Number | | number of participants | | From Baseline and until follow-up period of 57 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2.
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
|
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| Secondary | Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set | ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported. | The PD-L1 TC >= 25% LREM analysis set included participants identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | | number of participants | | From Baseline and until follow-up period of 57 months | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. | | OG001 | Platinum-based SoC | Participants received 1 of the following IV infusion treatment combination platinum-based SoC as per Investigator's choice on Day 1 of each 21-day cycle for 4 to 6 cycles or until documented PD or until specific treatment discontinuation criteria were met.
- Paclitaxel 175 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions.
- Gemcitabine 1000 or 1250 mg/m^2 and cisplatin 75 or 80 mg/m^2 (for squamous participants).
- Gemcitabine 1000 or 1250 mg/m^2 and carboplatin AUC 5 or 6 via infusions (for squamous participants).
- Pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2 (for non-squamous participants; pemetrexed maintenance dose was permitted).
- Pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6 via IV infusions (for non-squamous participants; pemetrexed maintenance dose was permitted).
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| Secondary | Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab | Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | The ADA evaluable analysis set included all participants in the safety analysis set who had a non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. | Posted | | Number | | percentage of participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. |
| |
| Secondary | Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set | Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | The ADA evaluable LREM analysis set included all participants in the safety analysis set who had a non-missing baseline ADA and at least 1 non-missing post-baseline ADA result, and identified by a prognostic model developed by AstraZeneca as having LREM. | Posted | | Number | | percentage of participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Durvalumab | Participants received durvalumab 20 mg/kg via IV infusion Q4W until documented PD or unacceptable toxicity or until specific treatment discontinuation criteria were met. |
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