Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004397-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care [SoC] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Durvalumab + platinum-based chemotherapy and radiation | Experimental | Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment. |
|
| Arm 2: Placebo + platinum-based chemotherapy and radiation | Placebo Comparator | Placebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive placebo as consolidation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab IV (intravenous infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The ORR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of complete response (CR) or partial response (PR) based on all participants in the FAS. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
Not provided
Principal inclusion criteria :
Principal exclusion criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Bradley, MD | AstraZeneca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Barretos | 14784-400 | Brazil | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| SAP | View source |
| CSP | View source |
Not provided
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.
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.
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.
The study had a screening period (up to 28 days), followed by a treatment and follow-up period (up to 1960 days). A total of 328 participants were randomized in a 2:1 ratio to receive durvalumab + standard of care (SoC) concurrent chemoradiotherapy (cCRT) group or placebo + SoC cCRT group.
This Phase III double-blind, placebo-controlled study was conducted in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) at 87 study centers in North and South America, Europe, and Asia Pacific. The results are reported for analysis with assessment until data cut-off (DCO) date of 07 September 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab + SoC CRT | Participants received durvalumab 1500 milligram (mg) intravenous (IV) infusion every 4 weeks (Q4W) until progressive disease (PD) or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT) was delivered using external beam radiation therapy (EBRT) of 5 fractions per week for ~6 weeks (± 3 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2020 | Sep 6, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo IV (intravenous infusion) |
|
| Cisplatin/ Etoposide | Drug | Cisplatin/ Etoposide, as per standard of care |
|
| Carboplatin/ Paclitaxel | Drug | Carboplatin /Paclitaxel, as per standard of care |
|
| Pemetrexed/ Cisplatin | Drug | Pemetrexed / Cisplatin, as per standard of care |
|
| Pemetrexed/ Carboplatin | Drug | Pemetrexed / Carboplatin , as per standard of care |
|
| Radiation | Radiation | 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy) |
|
| Overall Survival (OS) | The OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy. Median OS was calculated using the Kaplan-Meier technique. | From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days). |
| Percentage of Participants Alive at 24 Months From Randomization (OS24) | The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months. Median OS24 was calculated using the Kaplan-Meier technique. | Month 24 |
| Complete Response Rate (CRR) | The CRR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of CR. The CR was defined as disappearance of all target lesions since baseline. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| Duration of Response (DoR) | The DoR per RECIST 1.1 using BICR was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of PD. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. The DoR was calculated using the Kaplan-Meier technique. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| Disease Control Rate (DCR) | The DCR at 24 weeks per RECIST 1.1 using BICR was defined as the percentage of participants who had a best objective response of CR or PR in the first 25 weeks (to allow for late assessment within the assessment window) or who had stable disease for >= 23 weeks after randomization (to allow for an early assessment within the ± 1 week assessment window). | Week 24 |
| Time to Death or Distant Metastasis (TTDM) | The TTDM per RECIST 1.1 using BICR 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 the radiation field according to RECIST 1.1 or proven by biopsy. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| Time From Randomization to Second Progression (PFS2) | The PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS per Investigator assessment) or death. The date of the second progression was recorded by the Investigator and defined according to local standard clinical practice and could have involved any of objective radiological, symptomatic progression, or death. Median PFS2 was calculated using the Kaplan-Meier technique. | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| Serum Concentration of Durvalumab | Blood samples were collected to determine the concentration of durvalumab. | End of infusion on Week 0, pre-infusion on Weeks 4 and 12, and Month 3 follow-up |
| Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab | Blood samples were collected to determine the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence was defined as the number of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as either treatment-induced (post-baseline ADA positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to >= 4-fold during the study period). Treatment-induced ADA was defined as ADA positive only post-baseline and not detected at baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive assessments with at least 16 weeks between the first and last positive assessment, or ADA positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment without fulfilling the conditions for persistently positive. | Pre-dose on Day 1 of Cycles 1, 2 and 4 |
| Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months | Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a total score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status scale with higher scores on the global health status/quality of life (QoL) and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as a change from baseline of >=10. | At screening, 2, 4, 6, 8, 12, 16, and 20 weeks after randomization, then every 8 weeks ±1 week up to 52 weeks, and then every 12 weeks ±1 week thereafter until PFS2. Assessed up to 12 months. |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is the development of any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment. | From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days. |
| Curitiba |
| 81520-060 |
| Brazil |
| Research Site | Florianópolis | 88034-000 | Brazil |
| Research Site | Fortaleza | 60336-045 | Brazil |
| Research Site | Porto Alegre | 90035-003 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Ribeirão Preto | 14021-636 | Brazil |
| Research Site | Ribeirão Preto | 14048900 | Brazil |
| Research Site | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | São Paulo | 01246-000 | Brazil |
| Research Site | Brno | 656 53 | Czechia |
| Research Site | Ostrava | 703 00 | Czechia |
| Research Site | Prague | 128 08 | Czechia |
| Research Site | Budapest | 1083 | Hungary |
| Research Site | Budapest | 1121 | Hungary |
| Research Site | Győr | 9024 | Hungary |
| Research Site | Gyula | 5700 | Hungary |
| Research Site | Törökbálint | 2045 | Hungary |
| Research Site | Bangalore | 560068 | India |
| Research Site | Chennai | 600035 | India |
| Research Site | Gurgaon | 122001 | India |
| Research Site | Karamsad | 388325 | India |
| Research Site | Mumbai | 400053 | India |
| Research Site | Nashik | 422005 | India |
| Research Site | New Delhi | 110063 | India |
| Research Site | Vadodara | 390007 | India |
| Research Site | Bunkyō City | 113-8603 | Japan |
| Research Site | Fukuoka | 812-8582 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Kyoto | 606-8507 | Japan |
| Research Site | Nagoya | 464-8681 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Sendai | 980-0873 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Aguascalientes | 20230 | Mexico |
| Research Site | Guadalajara | 44280 | Mexico |
| Research Site | Mexico City | 0 3100 | Mexico |
| Research Site | Mérida | 97134 | Mexico |
| Research Site | México | 04700 | Mexico |
| Research Site | Orizaba | 94300 | Mexico |
| Research Site | La Libertad | 13013 | Peru |
| Research Site | Lima | 15033 | Peru |
| Research Site | Lima | L27 | Peru |
| Research Site | Lima | LIMA 27 | Peru |
| Research Site | Lima | LIMA 34 | Peru |
| Research Site | Lima | LIMA 41 | Peru |
| Research Site | Cebu City | 6000 | Philippines |
| Research Site | City of Taguig | 1634 | Philippines |
| Research Site | Iloilo City | 5000 | Philippines |
| Research Site | Makati | 1229 | Philippines |
| Research Site | Manila | 1015 | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Elblag | 02-300 | Poland |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Olsztyn | 10-228 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Arkhangelsk | 163045 | Russia |
| Research Site | Chelyabinsk | 454087 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Moscow | 115533 | Russia |
| Research Site | Moscow | 125367 | Russia |
| Research Site | Omsk | 644013 | Russia |
| Research Site | Rostov-on-Don | 344037 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Busan | 48108 | South Korea |
| Research Site | Chungcheongbuk-do | 28644 | South Korea |
| Research Site | Gyeongsangnam-do | 52727 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 6351 | South Korea |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Bangkok | 10400 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Khon Kaen | 40002 | Thailand |
| Research Site | Mueang | 50200 | Thailand |
| Research Site | Ankara | 06230 | Turkey (Türkiye) |
| Research Site | Ankara | Turkey (Türkiye) |
| Research Site | Antalya | 07059 | Turkey (Türkiye) |
| Research Site | Diyarbakır | 21280 | Turkey (Türkiye) |
| Research Site | Istanbul | 34030 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hanoi | 10000 | Vietnam |
| Research Site | Ho Chi Minh City | 700000 | Vietnam |
| CSR Synopsis | View source |
| FG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab + SoC CRT | Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
| BG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | The ORR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of complete response (CR) or partial response (PR) based on all participants in the FAS. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy. Median OS was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive at 24 Months From Randomization (OS24) | The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months. Median OS24 was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | The CRR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of CR. The CR was defined as disappearance of all target lesions since baseline. | The FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | The DoR per RECIST 1.1 using BICR was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of PD. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. The DoR was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. Only participants with objective response are analyzed. | Posted | Median | Inter-Quartile Range | months | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The DCR at 24 weeks per RECIST 1.1 using BICR was defined as the percentage of participants who had a best objective response of CR or PR in the first 25 weeks (to allow for late assessment within the assessment window) or who had stable disease for >= 23 weeks after randomization (to allow for an early assessment within the ± 1 week assessment window). | The FAS included all randomized participants. | Posted | Number | percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Death or Distant Metastasis (TTDM) | The TTDM per RECIST 1.1 using BICR 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 the radiation field according to RECIST 1.1 or proven by biopsy. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time From Randomization to Second Progression (PFS2) | The PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS per Investigator assessment) or death. The date of the second progression was recorded by the Investigator and defined according to local standard clinical practice and could have involved any of objective radiological, symptomatic progression, or death. Median PFS2 was calculated using the Kaplan-Meier technique. | The FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Durvalumab | Blood samples were collected to determine the concentration of durvalumab. | The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of durvalumab or matching placebo per protocol, for whom any post-dose data were available and did not violate or deviate from the protocol in ways that would significantly affect the PK analyses. Only participants analyzed at specific timepoint are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter | End of infusion on Week 0, pre-infusion on Weeks 4 and 12, and Month 3 follow-up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab | Blood samples were collected to determine the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence was defined as the number of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as either treatment-induced (post-baseline ADA positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to >= 4-fold during the study period). Treatment-induced ADA was defined as ADA positive only post-baseline and not detected at baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive assessments with at least 16 weeks between the first and last positive assessment, or ADA positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment without fulfilling the conditions for persistently positive. | The ADA analysis set included all participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. | Posted | Count of Participants | Participants | Pre-dose on Day 1 of Cycles 1, 2 and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months | Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a total score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status scale with higher scores on the global health status/quality of life (QoL) and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as a change from baseline of >=10. | The FAS included all randomized participants. Only participants analyzed at baseline through Month 12 are reported. | Posted | Mean | 95% Confidence Interval | units on a scale | At screening, 2, 4, 6, 8, 12, 16, and 20 weeks after randomization, then every 8 weeks ±1 week up to 52 weeks, and then every 12 weeks ±1 week thereafter until PFS2. Assessed up to 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is the development of any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment. | The Safety analysis set included all participants who received at least 1 dose of randomized treatment. | Posted | Number | percentage of participants | From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days. |
|
From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days.
The Safety analysis set included all participants who received at least 1 dose of randomized treatment. All-cause mortality was determined for participants in FAS.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Durvalumab + SoC CRT | Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). | 142 | 219 | 103 | 219 | 209 | 219 |
| EG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). | 69 | 109 | 56 | 108 | 106 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mesenteric lymphadenitis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic coagulopathy | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Carotid artery thrombosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypereosinophilic syndrome | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Dec 16, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C075609 | PE regimen |
| C053518 | CP protocol |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| Not Hispanic or Latino |
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
|
|
|
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|
| OG001 | Placebo + SoC CRT | Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens.
Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for ~6 weeks (± 3 days). |
|
|