Nonsquamous Nonsmall Cell Neoplasm of LungPhase 2DENALINCT02259582
A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing Pemetrexed, Carboplatin and demcizumab in people with Nonsquamous Nonsmall Cell Neoplasm of Lung, run by OncoMed Pharmaceuticals, Inc. at 45 sites in 5 countries.
Trial summary
A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- Pemetrexed, Carboplatin and demcizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 45 sitesin 5 countries
- Study dates
- Feb 2015to 7 Apr 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Signed Informed Consent Form
- Histologically or cytologically confirmed Stage IV non-squamous NSCLC
- Availability of FFPE (formalin-fixed paraffin-embedded) tumor tissue, either fresh core-needle-biopsied or archived
- Age > or = to 21 years
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
- Disease that is measurable per RECIST v1.1
- Adequate organ and marrow function
- For women of childbearing potential, agreement to use two effective forms of contraception
Main Exclusion Criteria:
- Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
- NSCLC with known EGFR (epidermal growth factor receptor ) mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4 [echinoderm microtubule-associated protein-like 4]-ALK [anaplastic lymphoma kinase])
- Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous NSCLC
- Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
- Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
- Malignancies other than non-squamous NSCLC successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
- Significant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this study
- Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study
Trial locations and contacts
45 sites in 5 countries.
45 sites in 5 countries
United States18 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Broome Oncology, LLC
Binghamton, New York, 13905
Roswell Park Cancer Institute
Buffalo, New York, 14263
Gabrail Cancer Center Research
Canton, Ohio, 44718
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
Karmanos Cancer Institute
Detroit, Michigan, 4820I
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Gaston Hematology & Oncology
Gastonia, North Carolina, 28054
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510-3221
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
Ocala Oncology Center
Ocala, Florida, 34471
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
University of California, San Francisco
San Francisco, California, . 94143-1705
Texas Oncology-Sherman
Sherman, Texas, 75090-0504
Edward H. Kaplan MD & Associates
Skokie, Illinois, 60076
Compass Oncology
Vancouver, Washington, 98684
Spain11 sites
Hospital Nuestra Senora de Sonsoles
Ávila, 05004
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Institute Catalan de Oncologia (ICO L'Hospitalet)
Barcelona, 08908
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Clinico San Carlos
Madrid, 28040
Hospital Madrid Universitario Sanchinarro
Madrid, 28050
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Universitario Virgen del Rocio
Seville, 41013
Australia8 sites
Monash Health, Monash Cancer Centre-Moorabbin
Bentleigh East, Victoria, 3165
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
The Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Royall Brisbane & Women's Hospital
Herston, Queensland, 4029
Icon Cancer Foundation
Milton, Queensland, 4064
North Coast Cancer Institute Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
St. John of God Subiaco Hospital
Subiaco, Western Australia, 6008
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Belgium4 sites
Ziekenhuisnetwerk Antwerpen- Koningin Paola Kinderzickenhuis
Antwerp, 2020
Grand Hopital de Charleroi- Site Notre-Dame
Charleroi, 6000
Centre Hospitalier Jolimont-Lobbes
La Louvière, 7100
CHR de Ia Citadelle
Liège, 4000
Italy4 sites
Smilow Cancer Hospital at Yale-New Haven
Aviano, Pordenone, 33081
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardy, 26100
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
About this study
Official title: A 2-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus Truncated Demcizumab as First-Line Treatment in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer
A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.
Read the detailed description
Patients will be enrolled at centers in North America, Western Europe, Australia and New Zealand. Up to 28 days (4 weeks) prior to treatment.
If enrolled in the study, you will receive intravenous (in the vein) infusions of demcizumab (or placebo), carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has gotten worse. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. After 8 cycles, if you have stable or improved disease, you may receive demcizumab (or placebo), every 21 days for 4 more cycles.
You will undergo assessments every 6 weeks to determine the status of your disease.
- Being tested
- Pemetrexed, Carboplatin, demcizumab
- Keywords
- Phase 2, histologically, confirmed, malignancy, metastatic, pemetrexed, carboplatin, carcinoma, non small cell lung, lung neoplasms, lung diseases
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Carcinoma, Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
CarboplatinDrug
demcizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Pem, carbo, placebo x 4 cycles | Placebo comparator | Pemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84 Receives: Drug: Pemetrexed; Drug: Carboplatin |
| Arm 2 Pem, carbo x 4 cycles, one course of dem | Active comparator | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84 Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: demcizumab |
| Arm 3 pem, carbo, dem x 4 cycles, dem retreatment | Active comparator | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg Receives: Drug: Pemetrexed; Drug: Carboplatin; Drug: demcizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
Measured: Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
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.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259582
- Sponsor's protocol ID
- M18-007
- Acronym
- DENALI
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2014
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus Truncated Demcizumab as First-Line Treatment in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02259582
- Acronym / sponsor ID
- DENALI / M18-007
- Keywords
- Phase 2, histologically, confirmed, malignancy, metastatic, pemetrexed, carboplatin, carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- Feb 2015 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Posted 20 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.
Detailed description
Patients will be enrolled at centers in North America, Western Europe, Australia and New Zealand. Up to 28 days (4 weeks) prior to treatment.
If enrolled in the study, you will receive intravenous (in the vein) infusions of demcizumab (or placebo), carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has gotten worse. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. After 8 cycles, if you have stable or improved disease, you may receive demcizumab (or placebo), every 21 days for 4 more cycles.
You will undergo assessments every 6 weeks to determine the status of your disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Pem, carbo, placebo x 4 cycles | Placebo comparator | Drug: Pemetrexed, Drug: CarboplatinPemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84 |
| Arm 2 Pem, carbo x 4 cycles, one course of dem | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: demcizumabPemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84 |
| Arm 3 pem, carbo, dem x 4 cycles, dem retreatment | Active comparator | Drug: Pemetrexed, Drug: Carboplatin, Drug: demcizumabPemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pemetrexed | Drug | Arm 1 Pem, carbo, placebo x 4 cycles, Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment |
| Carboplatin | Drug | Arm 1 Pem, carbo, placebo x 4 cycles, Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment |
| demcizumab | Drug | Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment |
Primary outcome
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.
Time frame: Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.
Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed, Carboplatin and demcizumab in people with Nonsquamous Nonsmall Cell Neoplasm of Lung, run by OncoMed Pharmaceuticals, Inc. at 45 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Spain, Australia, Belgium, Italy. 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 20 Aug 2018). 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?
To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms. (time frame: Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.