Previously Untreated Stage IV Non-Squamous Non Small Cell Lung CancerPhase 2NCT02087241
Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer
A Phase 2 study testing AZD1775, pemetrexed and carboplatin in people with Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer, run by AstraZeneca at 8 sites in United States.
Trial summary
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer
- What is being tested?
- AZD1775, pemetrexed and carboplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2014to Jun 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, Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
- No prior chemotherapy for locally advanced or metastatic disease
- Subjects with a known EGFR mutation must have received previous treatment with an EGFR tyrosine kinase inhibitor; and subjects with a known ALK translocation must have received previous treatment with an ALK inhibitor.
- No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Show all 33Show fewer
- Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Absolute neutrophil count (ANC) ≥1500/μL
- Hemoglobin (Hgb) ≥10 g/dL
- Platelets ≥100,000/μL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ≤3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases
- Total bilirubin ≤1.5 x ULN, unless secondary to Gilbert's disease
- Serum creatinine ≤1.5 x ULN and a calculate creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method
- 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 who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
- Predicted life expectancy ≥12 weeks
- Must be ≥18 years of age
- Willingness and ability to comply with study and follow-up procedures
- Ability to understand the nature of this trial and give written informed consent Exclusion criteria
- Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
- Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days
- Known central nervous system (CNS) disease
- Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates
- Any known hypersensitivity or contraindication to the components of study treatment
- Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association ([NYHA] Appendix G) ≥ Class 2
- Corrected QT interval (QTc) >470 msec (as calculated by Fridericia correction formula) at study entry or congenital long QT syndrome.
- Pregnant or lactating
- Any serious, active underlying medical condition that would impair the ability of the subjects to receive study treatment
- Unable or unwilling to take folic acid or vitamin B12
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Research Site
Cincinnati, Ohio
Research Site
Englewood, Colorado
Research Site
Fort Myers, Florida
Research Site
Fort Wayne, Indiana
Research Site
Nashville, Tennessee
Research Site
Orlando, Florida
Research Site
Peoria, Illinois
Research Site
Wichita, Kansas
About this study
Official title: A Phase II Study of AZD1775 Plus Pemetrexed and Carboplatin Followed by a Randomised Comparison of Pemetrexed and Carboplatin With or Without AZD1775 in Patients With Previously Untreated Stage IV Non-Squamous Non-Small-Cell Lung Cancer
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
Read the detailed description
This is a randomised, phase II trial comparing AZD1775 plus pemetrexed and carboplatin followed by maintenance AZD1775 and pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed in patients with previously untreated metastatic non-squamous NSCLC with TP53 mutations. The primary endpoint of the trial is assessment of progression-free survival (PFS).
- Being tested
- AZD1775, AZD1775 Matching Placebo, pemetrexed, carboplatin
- Keywords
- Stage IV Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1775Drug
Also called MK-1775
AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies
AZD1775 Matching PlaceboDrug
AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies
pemetrexedDrug
This drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells.
carboplatinDrug
This drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die.
| Study group | Role | What they receive |
|---|---|---|
| AZD1775 + carboplatin + pemetrexed | Experimental | Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. Receives: Drug: AZD1775; Drug: pemetrexed; Drug: carboplatin |
| Placebo + carboplatin + pemetrexed | Experimental | Randomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. Receives: Drug: AZD1775 Matching Placebo; Drug: pemetrexed; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
Measured: 6 months
Secondary outcomes (4)
Assess the Objective Response Rates in Each Arm
The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline
Measured: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess the Disease Control Rate in Each Treatment Arm
the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).
Measured: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess the Duration of Response in Each Treatment Arm
Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.
Measured: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess Overall Survival in Each Treatment Arm
Overall survival is defined as the time from the date of randomization until death due to any cause.
Measured: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
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 completionJun 2015
- Study completionJun 2015
Why it stopped: The sponsor decided to terminate the study.
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 Untreated Stage IV Non-Squamous 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Spigel, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087241
- Sponsor's protocol ID
- D6011C00002
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2014
- Last updated
- 29 Mar 2017
- 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 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of AZD1775 Plus Pemetrexed and Carboplatin Followed by a Randomised Comparison of Pemetrexed and Carboplatin With or Without AZD1775 in Patients With Previously Untreated Stage IV Non-Squamous Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02087241
- Acronym / sponsor ID
- D6011C00002
- Keywords
- Stage IV Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
Detailed description
This is a randomised, phase II trial comparing AZD1775 plus pemetrexed and carboplatin followed by maintenance AZD1775 and pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed in patients with previously untreated metastatic non-squamous NSCLC with TP53 mutations. The primary endpoint of the trial is assessment of progression-free survival (PFS).
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 |
|---|---|---|
| AZD1775 + carboplatin + pemetrexed | Experimental | Drug: AZD1775, Drug: pemetrexed, Drug: carboplatinRandomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. |
| Placebo + carboplatin + pemetrexed | Experimental | Drug: AZD1775 Matching Placebo, Drug: pemetrexed, Drug: carboplatinRandomised: AZD1775 + pemetrexed + carboplatin followed by maintenance AZD1775 + pemetrexed versus pemetrexed and carboplatin followed by maintenance pemetrexed. |
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, Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
- No prior chemotherapy for locally advanced or metastatic disease
- Subjects with a known EGFR mutation must have received previous treatment with an EGFR tyrosine kinase inhibitor; and subjects with a known ALK translocation must have received previous treatment with an ALK inhibitor.
- No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area.
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-1775AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies | Drug | AZD1775 + carboplatin + pemetrexed |
| AZD1775 Matching PlaceboAZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies | Drug | Placebo + carboplatin + pemetrexed |
| pemetrexedThis drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells. | Drug | AZD1775 + carboplatin + pemetrexed, Placebo + carboplatin + pemetrexed |
| carboplatinThis drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die. | Drug | AZD1775 + carboplatin + pemetrexed, Placebo + carboplatin + pemetrexed |
Primary outcome
Progression Free Survival
Time frame: 6 months
Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.
4 secondary outcomes
Assess the Objective Response Rates in Each Arm
Time frame: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess the Disease Control Rate in Each Treatment Arm
Time frame: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess the Duration of Response in Each Treatment Arm
Time frame: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Assess Overall Survival in Each Treatment Arm
Time frame: Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- 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 principal investigator
SCRI Development Innovations, LLC
8 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, pemetrexed and carboplatin in people with Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer, run by AstraZeneca at 8 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 29 Mar 2017). 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?
Progression Free Survival (time frame: 6 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 NCT02087241, 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 29 Mar 2017.