Trial · NCT02125461
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT02125461, Phase 3, Completed, AstraZeneca; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer. Trials, record NCT02125461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02125461
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- NCT number
- NCT02125461
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 713 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- MEDI4736, PLACEBO
- First posted
- 2014-04-29
- Last updated
- 2023-10-10
- Other registries' IDs
- eudract:2014-000336-42
- Results first posted
- 2019-01-30
- Limitations and caveats
Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique. |
| Primary | Overall Survival | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique. |
| Secondary | Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | ORR was defined as the percentage of patients 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. |
| Secondary | Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique. |
| Secondary | Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. |
| Secondary | Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months. |
| Secondary | Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique. |
| Secondary | Percentage of Patients Alive at 24 Months (OS24) | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months. |
| Secondary | Time to Second Progression or Death (PFS2) | Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique. |
| Secondary | Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | FAS included all randomized patients, analyzed on an intent-to-treat (ITT) basis. | Months | MEDIAN |
| PRIMARY | Overall Survival | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis. | Percentage of patients | NUMBER |
| SECONDARY | Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis. | Months | MEDIAN |
| SECONDARY | Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | FAS included all randomized patients, analyzed on an ITT basis. | Percentage of patients | NUMBER |
| SECONDARY | Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years. | FAS included all randomized patients, analyzed on an ITT basis. | Percentage of patients | NUMBER |
| SECONDARY | Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1 | Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. | Months | MEDIAN |
| SECONDARY | Percentage of Patients Alive at 24 Months (OS24) | From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. | Percentage of patients | NUMBER |
| SECONDARY | Time to Second Progression or Death (PFS2) | Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. | Months | MEDIAN |
| SECONDARY | Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30) | At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years. | FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≥ 10 were included in the analysis. | Months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Durvalumab (MEDI4736) | 16.8 | 95% Confidence Interval 13.0 to 18.1 | Months | |
| Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Placebo | 5.6 | 95% Confidence Interval 4.6 to 7.8 | Months | |
| Overall Survival | Durvalumab (MEDI4736) | NA | 95% Confidence Interval 34.7 to NA | Months | |
| Overall Survival | Placebo | 28.7 | 95% Confidence Interval 22.9 to NA | Months | |
| Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | Durvalumab (MEDI4736) | 30.0 | 95% Confidence Interval 25.79 to 34.53 | Percentage of patients | |
| Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1 | Placebo | 17.8 | 95% Confidence Interval 12.95 to 23.65 | Percentage of patients | |
| Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | Durvalumab (MEDI4736) | NA | 95% Confidence Interval 27.4 to NA | Months | |
| Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1 | Placebo | 18.4 | 95% Confidence Interval 6.7 to 24.5 | Months | |
| Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | Durvalumab (MEDI4736) | 55.9 | 95% Confidence Interval 51.0 to 60.4 | Percentage of patients | |
| Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1 | Placebo | 35.3 | 95% Confidence Interval 29.0 to 41.7 | Percentage of patients |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab (MEDI4736) | 476 | |
| Overall Study | STARTED | Placebo | 237 | |
| Overall Study | Full Analysis Set (FAS) | Durvalumab (MEDI4736) | 476 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 237 | |
| Overall Study | Received Treatment | Durvalumab (MEDI4736) | 473 | |
| Overall Study | Received Treatment | Placebo | 236 | |
| Overall Study | Safety Analysis Set | Durvalumab (MEDI4736) | 475 | |
| Overall Study | Safety Analysis Set | Placebo | 234 | |
| Overall Study | Completed 12 Months of Treatment | Durvalumab (MEDI4736) | 232 | |
| Overall Study | Completed 12 Months of Treatment | Placebo | 82 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events354
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab (MEDI4736) | 35 | 475 | 39 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 26 | 234 | 32 |
| other | Hyperthyroidism | Endocrine disorders | Durvalumab (MEDI4736) | 35 | 475 | 39 |
| other | Hyperthyroidism | Endocrine disorders | Placebo | 4 | 234 | 4 |
| other | Hypothyroidism | Endocrine disorders | Durvalumab (MEDI4736) | 54 | 475 | 62 |
| other | Hypothyroidism | Endocrine disorders | Placebo | 4 | 234 | 4 |
| other | Constipation | Gastrointestinal disorders | Durvalumab (MEDI4736) | 57 | 475 | 59 |
| other | Constipation | Gastrointestinal disorders | Placebo | 20 | 234 | 27 |
| other | Diarrhoea | Gastrointestinal disorders | Durvalumab (MEDI4736) | 87 | 475 | 136 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 46 | 234 | 56 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab (MEDI4736) | 262 | 475 |
| Total, all-cause mortality | Placebo | 154 | 234 |
| Total, other adverse events | Durvalumab (MEDI4736) | 436 | 475 |
| Total, other adverse events | Placebo | 212 | 234 |
| Total, serious adverse events | Durvalumab (MEDI4736) | 138 | 475 |
| Total, serious adverse events | Placebo | 54 | 234 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Durvalumab (MEDI4736) vs Placebo: deaths from any cause | Trial comparisons |
| Durvalumab (MEDI4736) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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