Non-small Cell Lung Cancer NSCLC
Conditions
Keywords
NSCLC, Durvalumab, Olaparib, Maintenance, Homologous Recombination Repair (HRR)
Brief summary
This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
Detailed description
Adult patients with a histologically or cytologically documented advanced NSCLC not amenable to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK fusions are eligible for enrollment. During the initial therapy phase, patients will receive treatment with Durvalumab along with the Investigator's choice of platinum-based doublet therapy for squamous NSCLC (nab-paclitaxel plus carboplatin or gemcitabine plus carboplatin/cisplatin) and non-squamous NSCLC (nab-paclitaxel plus carboplatin or pemetrexed plus carboplatin/cisplatin) for 4 cycles. Patients who have completed 4 cycles and not progressed throughout the initial therapy phase will be randomized in a 1:1 ratio into the maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus Olaparib maintenance therapy. Patients will receive maintenance treatment until specific discontinuation criteria are met, including clinical disease progression (as assessed by the Investigator) or RECIST 1.1-defined radiological Progressive Disease (PD), unacceptable toxicity, and withdrawal of consent. Tumor evaluation scans will be performed until objective disease progression as efficacy assessments. All patients will be followed for survival until the end of the study.
Interventions
DRUGDurvalumab
Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
Matching tablet
DRUGOlaparib
150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
Standard of Care chemotherapy (squamous and non-squamous patients)
DRUGGemcitabine+carboplatin
Standard of Care chemotherapy (squamous patients only)
Standard of Care chemotherapy (non-squamous patients only)
Standard of Care chemotherapy (squamous patients only)
Standard of Care chemotherapy (non-squamous patients only)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
\- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation. Patients must have tumors that lack activating EGFR mutations and ALK fusions. * (WHO)/(ECOG) performance status of 0 or 1 * No prior chemotherapy or any other systemic therapy for Stage IV NSCLC * Adequate organ and marrow function without blood transfusions in the past 28 days, * At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment: * Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. * Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection. * Ability to swallow whole oral medications. * All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (\<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken \<3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit.
Exclusion criteria
* Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. * Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerase (PARP) therapy, or immunomediated therapy * Active or prior documented autoimmune or inflammatory disorders. * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. * Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP) * untreated (CNS) metastases and/or carcinomatous meningitis * Active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1. PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization until the date of death due to any cause, up to 18 months. | Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause |
| Objective Response Rate | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization |
| Duration of Response | From date of first documented response until objective radiological disease progression or death, up to 18 months. | Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression. Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method. |
| Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression). |
| Concentration of Durvalumab | Assessed from start of initial therapy up to 2 years. | Concentration (pharmacokinetics) of durvalumab |
| Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity. |
| Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13. Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events. |
| Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months. | Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. |
| Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | From randomization until date of first symptom deterioration that is confirmed, up to 18 months. | Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events. |
| Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Assessed from start of initial therapy up to 2 years. | Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab |
| Number of Participants With Treatment-Related Adverse Events | From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months | Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) |
Countries
Belgium, Hungary, India, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Ukraine, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMyung-Ju Ahn, MD
Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea
Participant flow
Pre-assignment details
Initial therapy phase included participants who received durvalumab in combination with platinum based doublet chemotherapy.
Participants by arm
| Arm | Count |
|---|---|
| Durvalumab/Olaparib Combination Therapy Initial Therapy Phase (up to 4 cycles):
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:
* Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle
* Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle
* Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle
* Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle
* Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle
Followed by Maintenance Phase:
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily | 134 |
| Durvalumab/Placebo Therapy Initial Therapy Phase (up to 4 cycles):
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:
* Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle
* Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle
* Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle
* Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle
* Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle
Followed by Maintenance Phase:
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily | 135 |
| Total | 269 |
Baseline characteristics
| Characteristic | Durvalumab/Placebo Therapy | Total | Durvalumab/Olaparib Combination Therapy |
|---|---|---|---|
| Age, Continuous Mean age (years) | 63.0 Years STANDARD_DEVIATION 9.5 | 64.5 Years STANDARD_DEVIATION 9.64 | 65.9 Years STANDARD_DEVIATION 9.59 |
| Age, Customized Equal to or greater than 50 years to less than 65 years | 55 participants | 104 participants | 49 participants |
| Age, Customized Equal to or greater than 65 years to less than 75 years | 54 participants | 108 participants | 54 participants |
| Age, Customized Equal to or greater than 75 years | 12 participants | 36 participants | 24 participants |
| Age, Customized Less than 50 years | 14 participants | 21 participants | 7 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 264 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Histology Type Nonsquamous Cell Carcinoma | 76 participants | 152 participants | 76 participants |
| Histology Type Squamous Cell Carcinoma | 59 participants | 117 participants | 58 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 45 Participants | 82 Participants | 37 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 89 Participants | 185 Participants | 96 Participants |
| Sex: Female, Male Female | 38 Participants | 74 Participants | 36 Participants |
| Sex: Female, Male Male | 97 Participants | 195 Participants | 98 Participants |
| Smoking Status Current | 31 Participants | 66 Participants | 35 Participants |
| Smoking Status Former | 72 Participants | 146 Participants | 74 Participants |
| Smoking Status Never | 32 Participants | 57 Participants | 25 Participants |
| World Health Organization/Eastern Cooperative Oncology Group In Bed Less Than or Equal to 50 percent of the Time | 1 participants | 2 participants | 1 participants |
| World Health Organization/Eastern Cooperative Oncology Group Normal Activity | 54 participants | 106 participants | 52 participants |
| World Health Organization/Eastern Cooperative Oncology Group Restricted Activity | 80 participants | 161 participants | 81 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 89 / 401 | 44 / 134 | 45 / 135 |
| other Total, other adverse events | 368 / 401 | 116 / 134 | 104 / 134 |
| serious Total, serious adverse events | 104 / 401 | 25 / 134 | 19 / 134 |
Outcome results
Primary
Progression-free Survival
Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1. PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Death in the absence of progression | 8 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Progression-free at time of analysis | 44 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | RECIST progression: New Lesions | 44 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Progression-free prior to lost to follow-up | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Censored RECIST progression | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Progression-free prior to withdrawal of consent | 3 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | RECIST progression: Non Target Lesions | 28 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Progression-free prior to discontinuation due to other reason | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: Censored death | 1 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | Censored subjects: No post-baseline evaluable tumor assessment | 2 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival | RECIST progression: Target Lesions | 40 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: No post-baseline evaluable tumor assessment | 2 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | RECIST progression: Target Lesions | 63 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | RECIST progression: Non Target Lesions | 30 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | RECIST progression: New Lesions | 39 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Death in the absence of progression | 9 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Censored RECIST progression | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Censored death | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Progression-free at time of analysis | 34 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Progression-free prior to lost to follow-up | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Progression-free prior to withdrawal of consent | 2 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival | Censored subjects: Progression-free prior to discontinuation due to other reason | 0 Participants |
p-value: 0.07495% CI: [0.57, 1.02]Log Rank
Comparison: Median progression-free survival (months)95% CI: [5.3, 7.9]
Comparison: Median progression-free survival (months)95% CI: [3.7, 5.8]
Secondary
Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Fatigue | 0.15 change from baseline score | Standard Error 1.327 |
| Durvalumab/Olaparib Combination Therapy | Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Appetite loss | -0.13 change from baseline score | Standard Error 1.613 |
| Durvalumab/Placebo Therapy | Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Fatigue | -1.49 change from baseline score | Standard Error 1.456 |
| Durvalumab/Placebo Therapy | Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Appetite loss | -3.35 change from baseline score | Standard Error 1.779 |
Comparison: EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.95% CI: [-2.2, 5.47]
Comparison: EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.95% CI: [-1.46, 7.9]
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Dyspnoea | -1.27 change from baseline score | Standard Error 1.373 |
| Durvalumab/Olaparib Combination Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Coughing | -2.14 change from baseline score | Standard Error 1.98 |
| Durvalumab/Olaparib Combination Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain in chest | 1.31 change from baseline score | Standard Error 1.41 |
| Durvalumab/Placebo Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Dyspnoea | -0.76 change from baseline score | Standard Error 1.5 |
| Durvalumab/Placebo Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Coughing | -3.09 change from baseline score | Standard Error 2.172 |
| Durvalumab/Placebo Therapy | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain in chest | 3.57 change from baseline score | Standard Error 1.575 |
Comparison: EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.95% CI: [-4.47, 3.46]
Comparison: EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.95% CI: [-4.81, 6.71]
Comparison: EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.95% CI: [-6.39, 1.88]
Secondary
Concentration of Durvalumab
Concentration (pharmacokinetics) of durvalumab
Time frame: Assessed from start of initial therapy up to 2 years.
Population: Pharmacokinetic analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 02 Day 01 (Initial Therapy Phase) Pre dose | 76.812 μg/mL | Geometric Coefficient of Variation 84.586 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 08 (Maintenance Phase) Pre dose | 198.932 μg/mL | Geometric Coefficient of Variation 47.024 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 01 (Maintenance Phase) Post dose | 535.078 μg/mL | Geometric Coefficient of Variation 40.119 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 11 (Maintenance Phase) Pre dose | 210.794 μg/mL | Geometric Coefficient of Variation 42.117 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 01 Day 01 (Initial Therapy Phase) Post dose | 417.152 μg/mL | Geometric Coefficient of Variation 62.694 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 14 (Maintenance Phase) Pre dose | 276.612 μg/mL | Geometric Coefficient of Variation 50.137 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 02 (Maintenance Phase) Pre dose | 159.157 μg/mL | Geometric Coefficient of Variation 53.813 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 17 (Maintenance Phase) Pre dose | 264.096 μg/mL | Geometric Coefficient of Variation 55.519 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 04 Day 01 (Initial Therapy Phase) Pre dose | 155.461 μg/mL | Geometric Coefficient of Variation 58.251 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 20 (Maintenance Phase) Pre dose | 528.046 μg/mL | — |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Month 03 (Maintenance Phase) Pre dose | 12.289 μg/mL | Geometric Coefficient of Variation 450.125 |
| Durvalumab/Olaparib Combination Therapy | Concentration of Durvalumab | Cycle 05 (Maintenance Phase) Pre dose | 166.644 μg/mL | Geometric Coefficient of Variation 54.948 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Month 03 (Maintenance Phase) Pre dose | 12.769 μg/mL | Geometric Coefficient of Variation 225.898 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 01 Day 01 (Initial Therapy Phase) Post dose | 453.724 μg/mL | Geometric Coefficient of Variation 43.258 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 02 Day 01 (Initial Therapy Phase) Pre dose | 76.959 μg/mL | Geometric Coefficient of Variation 71.104 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 04 Day 01 (Initial Therapy Phase) Pre dose | 154.947 μg/mL | Geometric Coefficient of Variation 50.102 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 01 (Maintenance Phase) Post dose | 524.306 μg/mL | Geometric Coefficient of Variation 56.458 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 02 (Maintenance Phase) Pre dose | 160.315 μg/mL | Geometric Coefficient of Variation 54.409 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 05 (Maintenance Phase) Pre dose | 147.848 μg/mL | Geometric Coefficient of Variation 56.204 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 08 (Maintenance Phase) Pre dose | 154.057 μg/mL | Geometric Coefficient of Variation 54.911 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 11 (Maintenance Phase) Pre dose | 186.092 μg/mL | Geometric Coefficient of Variation 39.823 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 14 (Maintenance Phase) Pre dose | 182.042 μg/mL | Geometric Coefficient of Variation 39.341 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 17 (Maintenance Phase) Pre dose | 217.137 μg/mL | Geometric Coefficient of Variation 92.229 |
| Durvalumab/Placebo Therapy | Concentration of Durvalumab | Cycle 20 (Maintenance Phase) Pre dose | 112.276 μg/mL | — |
Secondary
Duration of Response
Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression. Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.
Time frame: From date of first documented response until objective radiological disease progression or death, up to 18 months.
Population: Participants with a response and with measurable disease at baseline from the full analysis set (maintenance phase)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Duration of Response | Percentage of participants remaining in response at 3 months | 90.5 percent |
| Durvalumab/Olaparib Combination Therapy | Duration of Response | Percentage of participants remaining in response at 6 months | 79.1 percent |
| Durvalumab/Olaparib Combination Therapy | Duration of Response | Percentage of participants remaining in response at 9 months | 69.2 percent |
| Durvalumab/Olaparib Combination Therapy | Duration of Response | Percentage of participants remaining in response at 12 months | 69.2 percent |
| Durvalumab/Placebo Therapy | Duration of Response | Percentage of participants remaining in response at 12 months | 65.7 percent |
| Durvalumab/Placebo Therapy | Duration of Response | Percentage of participants remaining in response at 3 months | 85.1 percent |
| Durvalumab/Placebo Therapy | Duration of Response | Percentage of participants remaining in response at 9 months | 65.7 percent |
| Durvalumab/Placebo Therapy | Duration of Response | Percentage of participants remaining in response at 6 months | 65.7 percent |
Secondary
Number of Participants With Treatment-Related Adverse Events
Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Safety analysis set.~One participant randomized to the durvalumab/placebo group did not receive any durvalumab or placebo and was excluded from the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Number of Participants With Treatment-Related Adverse Events | 83 Participants |
| Durvalumab/Placebo Therapy | Number of Participants With Treatment-Related Adverse Events | 54 Participants |
Secondary
Objective Response Rate
Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Full analysis set for maintenance phase, participants with measurable disease at baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Objective Response Rate | No Response | 107 Participants |
| Durvalumab/Olaparib Combination Therapy | Objective Response Rate | Response | 22 Participants |
| Durvalumab/Placebo Therapy | Objective Response Rate | No Response | 113 Participants |
| Durvalumab/Placebo Therapy | Objective Response Rate | Response | 18 Participants |
Secondary
Overall Survival
Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause
Time frame: From randomization until the date of death due to any cause, up to 18 months.
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Overall Survival | Death | 44 Participants |
| Durvalumab/Olaparib Combination Therapy | Overall Survival | Censored participants (still in survival at follow up or terminated study prior to death) | 90 Participants |
| Durvalumab/Placebo Therapy | Overall Survival | Death | 45 Participants |
| Durvalumab/Placebo Therapy | Overall Survival | Censored participants (still in survival at follow up or terminated study prior to death) | 90 Participants |
p-value: 0.60495% CI: [0.59, 1.36]Log Rank
Comparison: Median overall survival (months)
Comparison: Median overall survival (months)
Secondary
Presence of Anti-drug Antibodies (ADAs) for Durvalumab
Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab
Time frame: Assessed from start of initial therapy up to 2 years.
Population: Anti-drug antibody (ADA) evaluable set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA incidence (treatment-induced or treatment-boosted) | 5 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Treatment-boosted ADA | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA positive post-baseline and not detected at baseline (treatment-induced) | 5 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Persistent positive | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA positive post-baseline and positive at baseline | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Transient positive | 5 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA not detected at post-baseline and positive at baseline | 6 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Neutralizing anti-drug antibody positive at any visit | 1 Participants |
| Durvalumab/Olaparib Combination Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA prevalence (any ADA positive, baseline or post-baseline) | 11 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Neutralizing anti-drug antibody positive at any visit | 1 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA prevalence (any ADA positive, baseline or post-baseline) | 9 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA incidence (treatment-induced or treatment-boosted) | 4 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA positive post-baseline and positive at baseline | 1 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA positive post-baseline and not detected at baseline (treatment-induced) | 4 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | ADA not detected at post-baseline and positive at baseline | 4 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Treatment-boosted ADA | 0 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Persistent positive | 3 Participants |
| Durvalumab/Placebo Therapy | Presence of Anti-drug Antibodies (ADAs) for Durvalumab | Transient positive | 2 Participants |
Secondary
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population
Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Full analysis set (maintenance phase); HRRm subgroup
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Death in the absence of progression | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free at time of analysis | 2 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: New Lesions | 3 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to lost to follow-up | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Censored RECIST progression | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to withdrawal of consent | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: Non Target Lesions | 2 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to discontinuation due to other reason | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Censored death | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: No post-baseline evaluable tumor assessment | 0 Participants |
| Durvalumab/Olaparib Combination Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: Target Lesions | 1 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: No post-baseline evaluable tumor assessment | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: Target Lesions | 5 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: Non Target Lesions | 2 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | RECIST progression: New Lesions | 3 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Death in the absence of progression | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Censored RECIST progression | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Censored death | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free at time of analysis | 2 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to lost to follow-up | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to withdrawal of consent | 0 Participants |
| Durvalumab/Placebo Therapy | Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population | Censored subjects: Progression-free prior to discontinuation due to other reason | 0 Participants |
95% CI: [0.07, 2]
Comparison: Median progression-free survival (months)
Comparison: Median progression-free survival (months)95% CI: [1.2, 16.6]
Secondary
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30. NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time frame: From randomization until date of first symptom deterioration that is confirmed, up to 18 months.
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Fatigue | 8.8 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Nausea And Vomiting | 12.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Pain | 10.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Dyspnoea | 12.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Insomnia | 13.8 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Appetite Loss | 11.7 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Constipation | 12.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Diarrhoea | 13.8 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Physical Functioning | 12.0 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Role Functioning | 10.0 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Emotional Functioning | 12.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Cognitive Functioning | 10.2 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Social Functioning | 9.3 time to deterioration (months) |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Global Health Status/Quality of Life | 10.2 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Emotional Functioning | 11.0 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Fatigue | 10 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Diarrhoea | 11.5 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Nausea And Vomiting | 12.6 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Social Functioning | 10.0 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Pain | 9.7 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Physical Functioning | 12.0 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Dyspnoea | 11.0 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Cognitive Functioning | 10.6 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Insomnia | 10.6 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Role Functioning | 10.6 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Appetite Loss | 11.5 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | Global Health Status/Quality of Life | 9.7 time to deterioration (months) |
| Durvalumab/Placebo Therapy | Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 | EORTC QLQ-C30: Constipation | 12.0 time to deterioration (months) |
Secondary
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13. Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration. NA is not applicable. The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
Population: Full analysis set (maintenance phase)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Dyspnoea | 10.0 months |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Coughing | 11.7 months |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Haemoptysis | 15.0 months |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Chest | 13.8 months |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Arm Or Shoulder | 15.0 months |
| Durvalumab/Olaparib Combination Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Other Parts | 10.3 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Arm Or Shoulder | 9.7 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Dyspnoea | 9.7 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Chest | 11.5 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Coughing | 10.6 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Pain In Other Parts | 10.6 months |
| Durvalumab/Placebo Therapy | Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 | EORTC QLQ-LC13: Haemoptysis | 12.6 months |