Adults 18 to 130, any sex, with Squamous Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion SizesPrimary· From first dose until disease progression (Approximately 3 months)
Calculation of the percentage of patient who have a Complete Response or Partial Response to treatment which is confirmed by a repeat assessment 4 weeks later
Complete Response (CR)
Group
Value
95% CI
Open-label AZD2014
0
0 – 23.8
Partial Response (PR)
Group
Value
95% CI
Open-label AZD2014
0
0 – 23.8
Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)Secondary· Informed consent until end of safety follow up (Approx 10 months if all treatment cycles are completed)
The safety and tolerability of AZD2014 with weekly paclitaxel as assessed with the collection of Adverse Events and Serious Adverse Events as reported during clinic visits. In addition, clinical assessments were made throughout the on treatment period including blood test for chemistry, haematology, and blood clotting. In addition to clinical observations such as vital signs, and cardiac function through the use of ECG.
Any findings from the above assessments which were considered to be abnornal and clinically significant by the doctor were reported as (AEs or SAEs).
Adverse Event (AE)
Group
Value
95% CI
Open-label AZD2014
11
Serious Adverse Event (SAE)
Group
Value
95% CI
Open-label AZD2014
4
Overall Survival: Median Number of Days Between the First Dose and End of Life Due to Any CauseSecondary· From first dose until end of life (Approx 9 months)
Assessment of the duration of overall survival in weeks through direct patient follow-up. Any patient not known to have died at the time of analysis censored at the last recorded date the patient was known to be alive
Group
Value
95% CI
Open-label AZD2014
104
27 – 164
Best Objective Response: Number of Patients Who Experienced a Best Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not-Evaluable (NE), Through Measurement of Tumour Lesion Sizes.Secondary· From Baseline until Disease Progression (Approx 3 months)
Per Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed through imaging (CT or MRI scan) or clinical examination; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR) \>=30% decrease in sum of target lesion longest diameter; Progressive Disease \>=20% increase in sum of target lesion longest diameter; Stable Disease (SD) increase or decrease amounting to neither PR or PD. Overall tumour assessment based on quantitative assessment of target lesions and qualitative assessment of non-target lesions in line with RECIST criteria.
PD
Group
Value
95% CI
Open-label AZD2014
6
SD
Group
Value
95% CI
Open-label AZD2014
5
PR
Group
Value
95% CI
Open-label AZD2014
0
CR
Group
Value
95% CI
Open-label AZD2014
0
Disease Control Rate: Percentage of Patients Who Achieve Partial Response, Complete Response or Stable Disease Through Assessment of Tumour Lesion SizesSecondary· From first dose until documented progression and at least 6 weeks after the start of treatment for assessment of Stable Disease - Assessed at 6, 13 and 20 Weeks
Assessment of the disease control rate, percentage of patients who experience a response through assessment of tumour lesions by RECIST 1.1 criteria
Disease Control Rate at 6 Weeks
Group
Value
95% CI
Open-label AZD2014
45.5
24.1 – 68.2
Disease Control Rate at 13 Weeks
Group
Value
95% CI
Open-label AZD2014
18.2
4.9 – 41.5
Disease Control Rate at 20 Weeks
Group
Value
95% CI
Open-label AZD2014
18.2
4.9 – 41.5
Change in Tumour Size: Median Percentage Change in Tumour Size in mm by Measurement of Tumour Lesion SizesSecondary· From baseline until documented progression (Approx 3 months)
Assessment of the degree of tumour response through measurement of the change in tumour lesion sizes
Group
Value
95% CI
Open-label AZD2014
0.0
-33.3 – 41.8
Progression Free Survival: Median Number of Days Between Start of Dosing Until Objective Disease Progression Through Measurement of Tumour Lesion SizesSecondary· From date of first dose until documented progression or end of life (Approx 3 months)
Assessment of the duration of progression free survival through assessment of tumour lesions by RECIST 1.1 criteria
Group
Value
95% CI
Open-label AZD2014
91
15 – 98
Evaluate the Effect of the Combination of AZD2014 and Paclitaxel on Pharmacokinetics Assessment of CmaxSecondary· Assessment at multiple timepoints in Group A patients. Samples will be taken at pre-dose and at 10 further timepoints on day 1 and at pre-dose and 9 further timepoints on days 3 and 8
To determine the effect of co-administration of paclitaxel on the PK of oral AZD2014 and the effect of co administration of oral AZD2014 on the PK of paclitaxel (Group A) by: PK parameters for each in the presence and absence of the other by intensive PK sampling and NCA techniques.
Paclitaxel Cmax
Group
Value
95% CI
Open-label AZD2014
2240
1500 – 2980
AZD2014 Cmax
Group
Value
95% CI
Open-label AZD2014
1021
741 – 1300
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from the time of informed consent throughout the treatment period until the end of the follow-up period. The follow-up period if defined as 28 days after study treatment is discontinued for a given patient. Total duration of collection period = approximately 10 months if all cycles and follow-up period is completed..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 3 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02403895.