An observational study in Non Small Cell Lung Cancer, sponsored by AstraZeneca. Completed at 7 sites in Taiwan. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by AstraZeneca · Observational
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Among 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca — 25 open to participants now, 78 under way, 28 of them phase 3. Carcinoma, Non-Small-Cell Lung · AstraZeneca.
Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, this one is the 32nd largest by enrollment of the 67 observational ones that give a count, is one of 20 that started in 2018, is one of 67 observational ones, and was the 100th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →25 of the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in Australia, Georgia, Poland and 2 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 48 · Phase 3 44 · Phase 4 10
First in 2000; this study’s year is marked. 20 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 423 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 152 across the 137 interventional studies, 350 across the 67 observational. Of the 123 that completed or were terminated, 45 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
16 of the studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
| NCT05120349Phase 3AstraZenecaA Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection | 2027-08-02 |
| NCT05687266Phase 3AstraZenecaPhase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations | 2027-11-01 |
| NCT05456867AstraZenecaA Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia | 2026-11-30 |
Add all 16 to your calendar (.ics) → With an account.
Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP
All the available patients who have participated in the AZD9291 EAP will be screened for the eligible criteria for data collection in this observational study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study also gives Osimertinib. No intervention listed here names it: that was found by reading the record.
Progression free survival (PFS)
PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression
Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Overall survival (OS)
OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause
Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months
Response Rate (RR)
RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment
Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Disease Control Rate (DCR)
DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment.
Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Time to treatment discontinuation (TTD)
TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason
Time frame: Time from patient first dose to data cut off (up to 32 months)
Ran from Jun 2018 to primary completion in Dec 2019, 18 months.
Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's 18 months is below that.
Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →