Previously Treated Non Small Cell Lung CancerPhase 2NCT02087176
A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
A Phase 2 study testing AZD1775, Antimitotic Agent and pegfiligrastim in people with Previously Treated Non Small Cell Lung Cancer, run by AstraZeneca at 12 sites in United States.
Trial summary
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Treated Non Small Cell Lung Cancer
- What is being tested?
- AZD1775, Antimitotic Agent and pegfiligrastim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Histologic or cytologic diagnosis of advanced NSCLC, excluding large cell neuroendocrine, and mixed NSCLC/small-cell histologies
- Failure of one prior platinum-based doublet treatment for advanced NSCLC (either due to progressive disease or toxicity)
- Measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 testing
Show all 33Show fewer
- Male or female ≥18 years-of-age
- Subjects may have received radiation for palliation prior to starting study treatment if they have recovered from the side effects of such therapy
- Absolute neutrophil count (ANC) ≥1500/μL
- Haemoglobin (Hgb) ≥9 g/dL
- Platelets ≥100,000/uL
- Adequate liver function defined as:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal limits (WNL) or ≤2.5 x upper limit of normal (ULN), if liver metastases are present
- Serum bilirubin WNL
- Adequate renal function
- Ability to swallow oral medication
- Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops
- Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures
- Predicted life expectancy ≥12 weeks
- Willingness and ability to comply with study and follow-up procedures
- Ability to understand the investigational nature of this study and give written informed consent
- Most recent chemotherapy ≤21 days or have not recovered from the side effects > Grade 1.
- Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting AZD1775 or has not recovered from side effects of such therapy
- Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days
- Known central nervous system (CNS) disease
- Any known hypersensitivity or contraindication to the components of study treatment (AZD1775 and docetaxel)
- Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association [NYHA] ≥ Class 2
- Pregnant or lactating
- Concurrent administration of medications or foods that are strong inhibitors of
- Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment
- Presence of other active cancers, or history of treatment for invasive cancer ≤3 years
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Site
Birmingham, Alabama
Research Site
Cincinnati, Ohio
Research Site
Durham, North Carolina
Research Site
Englewood, Colorado
Research Site
Fayetteville, Arkansas
Research Site
Louisville, Kentucky
Research Site
Milwaukee, Wisconsin
Research Site
Nashville, Tennessee
Research Site
Orlando, Florida
Research Site
Pittsburgh, Pennsylvania
Research Site
Scottsdale, Arizona
Research Site
Wichita, Kansas
About this study
Official title: A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 Plus Docetaxel and Placebo Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer Patients
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients
Read the detailed description
This multicentre trial consists of an open-labelled single cohort lead-in (Part A) followed by a phase II double-blind, randomised, placebo-controlled comparison of AZD1775 (or placebo) and an antimitotic agent. Review by a central laboratory of fresh tumour or archival tumour samples will be required prior to study entry to assess TP53 mutation status. However, subjects will be allowed to enter the single cohort (Part A) regardless of TP53 mutation status (wild-type or mutant). In addition, patients in the single cohort Part A treatment group will be asked to consent to limited sample collections for assessment of pharmacokinetic parameters.
- Being tested
- AZD1775, AZD1775 Placebo, Antimitotic Agent, pegfiligrastim
- Keywords
- NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1775Drug
Also called MK-1775; Neulasta
AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
AZD1775 PlaceboDrug
Also called MK-1775; Neulasta
Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Antimitotic AgentDrug
Also called antiimitotic agent
The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.
pegfiligrastimDrug
Also called Neulasta
Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
| Study group | Role | What they receive |
|---|---|---|
| AZD 1775, antimitotic, pegfilgrastim | Experimental | AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles Receives: Drug: AZD1775; Drug: Antimitotic Agent; Drug: pegfiligrastim |
| Placebo + antimitotic + pegfilgrastim | Placebo comparator | Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles Receives: Drug: AZD1775 Placebo; Drug: Antimitotic Agent; Drug: pegfiligrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.
Measured: Up to 20 months
Secondary outcomes (1)
Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel
Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.
Measured: Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The study was terminated early by the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Previously Treated Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Spigel, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087176
- Sponsor's protocol ID
- D6011C00001
- Status last verified
- Apr 2016
- First submitted
- 7 Mar 2014
- Last updated
- 14 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Johnson ML, Dakhil SR, Beck JT, Sadiq A, Menon S, Mugundu GM, Chmielecki J, Spigel DR. Two Phase II Trials of Adavosertib, a Wee1 Inhibitor with Docetaxel or Carboplatin plus Pemetrexed in Non-small-cell Lung Cancer. Target Oncol. 2025 Nov;20(6):967-978. doi: 10.1007/s11523-025-01177-x. Epub 2025 Nov 10.
PubMed 41212474
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 Plus Docetaxel and Placebo Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02087176
- Acronym / sponsor ID
- D6011C00001
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the sponsor.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 14 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients
Detailed description
This multicentre trial consists of an open-labelled single cohort lead-in (Part A) followed by a phase II double-blind, randomised, placebo-controlled comparison of AZD1775 (or placebo) and an antimitotic agent. Review by a central laboratory of fresh tumour or archival tumour samples will be required prior to study entry to assess TP53 mutation status. However, subjects will be allowed to enter the single cohort (Part A) regardless of TP53 mutation status (wild-type or mutant). In addition, patients in the single cohort Part A treatment group will be asked to consent to limited sample collections for assessment of pharmacokinetic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD 1775, antimitotic, pegfilgrastim | Experimental | Drug: AZD1775, Drug: Antimitotic Agent, Drug: pegfiligrastimAZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles |
| Placebo + antimitotic + pegfilgrastim | Placebo comparator | Drug: AZD1775 Placebo, Drug: Antimitotic Agent, Drug: pegfiligrastimPlacebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Provision of informed consent prior to any study specific procedures
- Histologic or cytologic diagnosis of advanced NSCLC, excluding large cell neuroendocrine, and mixed NSCLC/small-cell histologies
- Failure of one prior platinum-based doublet treatment for advanced NSCLC (either due to progressive disease or toxicity)
- Measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1775Also: MK-1775; NeulastaAZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity | Drug | AZD 1775, antimitotic, pegfilgrastim |
| AZD1775 PlaceboAlso: MK-1775; NeulastaPlacebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity | Drug | Placebo + antimitotic + pegfilgrastim |
| Antimitotic AgentAlso: antiimitotic agentThe antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug. | Drug | AZD 1775, antimitotic, pegfilgrastim, Placebo + antimitotic + pegfilgrastim |
| pegfiligrastimAlso: NeulastaPegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often. | Drug | AZD 1775, antimitotic, pegfilgrastim, Placebo + antimitotic + pegfilgrastim |
Primary outcome
Objective Response Rate
Time frame: Up to 20 months
Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.
1 secondary outcome
Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel
Time frame: Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41212474Johnson ML, Dakhil SR, Beck JT, Sadiq A, Menon S, Mugundu GM, Chmielecki J, Spigel DR. Two Phase II Trials of Adavosertib, a Wee1 Inhibitor with Docetaxel or Carboplatin plus Pemetrexed in Non-small-cell Lung Cancer. Target Oncol. 2025 Nov;20(6):967-978. doi: 10.1007/s11523-025-01177-x. Epub 2025 Nov 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Spigel, MD study chair
SCRI Development Innovations, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1775, Antimitotic Agent and pegfiligrastim in people with Previously Treated Non Small Cell Lung Cancer, run by AstraZeneca at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.