A Phase 2 interventional study of Durvalumab + Oleclumab and Durvalumab in Stage III Non-small Cell Lung Cancer and Unresectable, sponsored by MedImmune LLC. Completed at 73 sites in 9 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 189 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
First submitted after MedImmune LLC became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
durvalumab IV
Drug: Durvalumab
durvalumab IV and oleclumab IV
Drug: Durvalumab + Oleclumab
durvalumab IV and monalizumab IV
Drug: Durvalumab + Monalizumab
Drug pages: Durvalumab · Oleclumab
Durvalumab + Oleclumab
Also known as: Durvalumab (MEDI-4736), Oleclumab (MEDI-9447)
Durvalumab
Also known as: Durvalumab (MEDI-4736)
Drug pages: Durvalumab · Monalizumab
Durvalumab + Monalizumab
Also known as: Durvalumab (MEDI-4736), Monalizumab (IPH2201)
Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Time frame: ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint
Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events
Time frame: From time of signature of informed consent up to 15 months post the first dose of study treatment
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values
Time frame: From baseline up to 15 months post the first dose of study treatment
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events
Time frame: From baseline up to 15 months post the first dose of study treatment
Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR
Time frame: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).
Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1.
Time frame: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).
Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first
Time frame: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).
Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization.
Time frame: PFS rate at 12 months after randomization.
Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
OS was defined as the time from the date of randomization until death due to any cause.
Time frame: From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023).
Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents
Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate.
Time frame: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1
Pharmacokinetics of Novel Agents in Combination With Durvalumab
Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate.
Time frame: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) 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. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
Time frame: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) 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. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
Time frame: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1
The first participant was randomized into the study on 3 January 2019 and the last participant was randomized on 6 July 2020.
| Milestone | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Started | 67 | 60 | 62 |
| Completed | 21 | 29 | 30 |
| Not completed | 46 | 31 | 32 |
| Withdrew: Death | 27 | 23 | 24 |
| Withdrew: Lost to follow-up | 6 | 2 | 1 |
| Withdrew: Withdrawal by subject | 10 | 4 | 6 |
| Withdrew: Progressive disease | 2 | 1 | 0 |
| Withdrew: Not treated | 1 | 1 | 1 |
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
| Percentage of Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | 23.9 (14.3 to 35.9) | 35.0 (23.1 to 48.4) | 40.3 (28.1 to 53.6) |
The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events
| Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Participants with any TEAEs | 65 | 57 | 61 |
| Participants with any serious TEAEs | 23 | 20 | 17 |
The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values
| Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Participants with any Grade 3 or 4 Alanine Aminostransferase (U/L) toxicities | 1 | 0 | 0 |
| Participants with any Grade 3 or 4 Albumin (g/dL) toxicities | 2 | 0 | 0 |
| Participants with any Grade 3 or 4 Amylase (U/L) toxicities | 1 | 0 | 2 |
| Participants with any Grade 3 or 4 Aspartate Aminotransferase (U/L) toxicities | 1 | 0 | 1 |
| Participants with any Grade 3 or 4 Creatinine (mg/dL) toxicities | 1 | 0 | 0 |
| Participants with any Grade 3 or 4 Creatinine Clearance Rate (mL/min) toxicities | 2 | 1 | 0 |
| Participants with any Grade 3 or 4 Gamma Glutamyl Transferase (U/L) toxicities | 1 | 0 | 0 |
| Participants with any Grade 3 or 4 Hyperkalemia (mEq/L) toxicities | 0 | 0 | 2 |
| Participants with any Grade 3 or 4 Hypokalemia (mEq/L) toxicities | 1 | 0 | 1 |
| Participants with any Grade 3 or 4 Hypocalcemia (corrected) (mg/dL) toxicities | 1 | 0 | 0 |
| Participants with any Grade 3 or 4 Hypernatremia (mEq/L) toxicities | 1 | 2 | 1 |
| Participants with any Grade 3 or 4 Lipase (U/L) toxicities | 1 | 4 | 2 |
| Participants with any Grade 3 or 4 Hemoglobin increased (g/dL) toxicities | 3 | 0 | 0 |
| Participants with any Grade 3 or 4 Lymphocyte count increased (10^3/uL) toxicities | 19 | 11 | 11 |
| Participants with any Grade 3 or 4 Platelet count decreased (10^3/uL) toxicities | 1 | 0 | 0 |
The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events
| Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Hypertension | 3 | 3 | 0 |
| Hypotension | 2 | 0 | 3 |
| Palpitations | 0 | 0 | 1 |
| Pyrexia | 6 | 8 | 10 |
| Tachycardia | 1 | 2 | 2 |
The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR
| Months | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | NA (14.1 to NA) | 29.9 (17.1 to NA) | 23.0 (10.2 to NA) |
Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1.
| Percentage of Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | 58.2 (45.5 to 70.2) | 80.0 (67.7 to 89.2) | 79.0 (66.8 to 88.3) |
PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first
| Months | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | 7.3 (4.0 to 13.8) | 21.1 (10.4 to 30.9) | 19.8 (13.6 to 31.3) |
PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization.
| Percentage of Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | 37.6 (24.7 to 50.4) | 63.5 (49.2 to 74.7) | 73.2 (59.6 to 82.9) |
OS was defined as the time from the date of randomization until death due to any cause.
| Months | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents | 40.9 (22.6 to NA) | NA (31.9 to NA) | NA (31.3 to NA) |
Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate.
| Micrograms per milliliter | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| Cycle 1 Day 1: End of Infusion | 318.0 ± 199.6 | 277.4 ± 316.1 | 223.7 ± 1272 |
| Cycle 2 Day 1: Pre-Dose | 59.7 ± 58.6 | 68.0 ± 49.9 | 74.3 ± 40.7 |
| Cycle 7 Day 1: Pre-Dose | 151.6 ± 37.7 | 127.9 ± 66.4 | 176.5 ± 45.6 |
| Cycle 11 Day 1: Pre-Dose | 156.7 ± 50.0 | 146.5 ± 91.3 | 172.4 ± 40.4 |
Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate.
| Micrograms per milliliter | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|
| Cycle 1 Day 1: End of Infusion | 581.6 ± 210.5 | 160.0 ± 286.4 |
| Cycle 2 Day 1: Pre-Dose | 216.4 ± 58.6 | 102.6 ± 39.2 |
| Cycle 7 Day 1: Pre-Dose | 124.5 ± 109.0 | 194.5 ± 33.8 |
| Cycle 11 Day 1: Pre-Dose | 132.0 ± 166.8 | 196.2 ± 48.7 |
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) 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. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
| Participants | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|---|
| ADA positive at any visit (ADA prevalence) | 3 | 1 | 2 |
| Treatment-emergent ADA positive (ADA incidence) | 1 | 0 | 0 |
| Treatment-boosted ADA | 0 | 0 | 0 |
| Treatment-induced ADA (positive post-baseline only) | 1 | 0 | 0 |
| ADA positive at baseline only | 2 | 1 | 2 |
| ADA positive post-baseline and positive at baseline | 0 | 0 | 0 |
| Persistently positive | 1 | 0 | 0 |
| Transiently positive | 0 | 0 | 0 |
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) 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. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
| Participants | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) |
|---|---|---|
| ADA positive at any visit (ADA prevalence) | 0 | 1 |
| Treatment-emergent ADA positive (ADA incidence) | 0 | 1 |
| Treatment-boosted ADA | 0 | 0 |
| Treatment-induced ADA (positive post-baseline only) | 0 | 1 |
| ADA positive at baseline only | 0 | 0 |
| ADA positive post-baseline and positive at baseline | 0 | 0 |
| Persistently positive | 0 | 0 |
| Transiently positive | 0 | 1 |
Collected over AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Durvalumab Monotherapy | 27/66 (40.9%) | 23/66 (34.8%) | 61/66 (92.4%) |
| Durvalumab + Oleclumab | 23/59 (39%) | 20/59 (33.9%) | 52/59 (88.1%) |
| Durvalumab + Monalizumab | 24/61 (39.3%) | 17/61 (27.9%) | 58/61 (95.1%) |
| Event | Durvalumab Monotherapy | Durvalumab + Oleclumab | Durvalumab + Monalizumab |
|---|---|---|---|
| PneumonitisRespiratory, thoracic and mediastinal disorders | 3/66 | 6/59 | 2/61 |
| PneumoniaInfections and infestations | 5/66 | 4/59 | 0/61 |
| Radiation pneumonitisInjury, poisoning and procedural complications | 1/66 | 2/59 | 0/61 |
| SeizureNervous system disorders | 2/66 | 0/59 | 0/61 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/66 | 0/59 | 1/61 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 2/66 | 1/59 | 0/61 |
| PyrexiaGeneral disorders | 0/66 | 1/59 | 1/61 |
| Sudden deathGeneral disorders | 0/66 | 1/59 | 0/61 |
| AppendicitisInfections and infestations | 0/66 | 1/59 | 0/61 |
| Enterocolitis infectiousInfections and infestations | 0/66 | 1/59 | 0/61 |
| Event | Durvalumab Monotherapy | Durvalumab + Oleclumab | Durvalumab + Monalizumab |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 11/66 | 19/59 | 26/61 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 17/66 | 15/59 | 14/61 |
| PruritusSkin and subcutaneous tissue disorders | 7/66 | 10/59 | 15/61 |
| AstheniaGeneral disorders | 10/66 | 11/59 | 15/61 |
| HypothyroidismEndocrine disorders | 10/66 | 8/59 | 13/61 |
| DiarrhoeaGastrointestinal disorders | 7/66 | 8/59 | 13/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 11/66 | 10/59 | 11/61 |
| RashSkin and subcutaneous tissue disorders | 6/66 | 9/59 | 8/61 |
| ConstipationGastrointestinal disorders | 10/66 | 4/59 | 2/61 |
| PyrexiaGeneral disorders | 6/66 | 7/59 | 9/61 |
The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
| Age, Continuous(years) | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) | Total |
|---|---|---|---|---|
| Mean | 65.5 ± 8.9 | 63.8 ± 9.5 | 64.4 ± 9.2 | 64.6 ± 9.2 |
| Sex: Female, Male(Participants) | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) | Total |
|---|---|---|---|---|
| Female | 22 | 18 | 20 | 60 |
| Male | 45 | 42 | 42 | 129 |
| Ethnicity (NIH/OMB)(Participants) | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 2 | 8 |
| Not Hispanic or Latino | 63 | 56 | 59 | 178 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 5 | 4 | 5 | 14 |
| Black or African American | 1 | 5 | 2 | 8 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| White | 57 | 47 | 55 | 159 |
| Other | 1 | 2 | 0 | 3 |
| Missing | 2 | 1 | 0 | 3 |
| Region of Enrollment(Participants) | Control Arm (Durvalumab Monotherapy) | Arm A (Durvalumab + Oleclumab) | Arm B (Durvalumab + Monalizumab) | Total |
|---|---|---|---|---|
| Canada | 3 | 2 | 1 | 6 |
| France | 15 | 19 | 5 | 39 |
| Hong-Kong | 1 | 2 | 3 | 6 |
| Italy | 0 | 3 | 3 | 6 |
| Portugal | 3 | 0 | 3 | 6 |
| Spain | 19 | 12 | 22 | 53 |
| Taiwan | 1 | 0 | 1 | 2 |
| United States | 25 | 22 | 24 | 71 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Dec 2018 to primary completion in Jul 2023, 54 months.
Results were first posted in Oct 2024, 1 year 2 months after primary completion.
Of 292 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's 54 months is above that.
Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Durvalumab · Oleclumab · Monalizumab
Carcinoma, Non-Small-Cell Lung →