Non Small Cell Lung CancerPhase 1/2NCT01666977
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
A Phase 1/2 study testing AMG 386, Pemetrexed and Carboplatin in people with Non Small Cell Lung Cancer, run by Amgen at 35 sites in 6 countries.
Trial summary
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- AMG 386, Pemetrexed and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 35 sitesin 6 countries
- Study dates
- Aug 2012to Nov 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
- Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
- Other criteria may apply
Who cannot join
- Any prior chemotherapy or targeted therapy for non-squamous NSCLC
- Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
- History or presence of central nervous system metastases
- Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
Show all 11Show fewer
- History of pulmonary hemorrhage or gross hemoptysis within 6 months
- History of arterial or venous thromboembolism within 12 months
- History of clinically significant bleeding within 6 months
- Clinically significant cardiovascular disease within 12 months
- Other criteria may apply
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
United States13 sites
Research Site
Bismarck, North Dakota, 58501
Research Site
Fayetteville, Arkansas, 72703
Research Site
Greenville, South Carolina, 29605
Research Site
Hannover, New Hampshire, 03756
Research Site
Hot Springs, Arkansas, 71913
Research Site
Los Angeles, California, 90048
Research Site
Paducah, Kentucky, 42003
Research Site
Palm Springs, California, 92262
Research Site
Peoria, Illinois, 61615
Research Site
Pleasant Hill, California, 94523
Research Site
San Diego, California, 92123
Research Site
Santa Monica, California, 90403
Research Site
The Bronx, New York, 10461
Australia7 sites
Research Site
Bentleigh East, Victoria, 3165
Research Site
Camperdown, New South Wales, 2050
Research Site
Heidelberg, Victoria, 3084
Research Site
Herston, Queensland, 4029
Research Site
Kogarah, New South Wales, 2217
Research Site
Randwick, New South Wales, 2031
Research Site
Tweed Heads, New South Wales, 2485
Canada7 sites
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
Laval, Quebec, H7M 3L9
Research Site
Lévis, Quebec, G6V 3Z1
Research Site
Montreal, Quebec, H2L 4M1
Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Toronto, Ontario, M4N 3M5
Greece4 sites
Research Site
Heraklion, 71110
Research Site
Larissa, 41110
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 56429
Spain3 sites
Research Site
Madrid, Madrid, 28046
Research Site
Málaga, Andalusia, 29010
Research Site
Zaragoza, Aragon, 50009
About this study
Official title: A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Read the detailed description
To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- AMG 386, AMG 386 Placebo, Pemetrexed, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 386Drug
15mg/kg
AMG 386Drug
30 mg/kg
AMG 386 PlaceboDrug
AMG 386 Placebo
PemetrexedDrug
Pemetrexed 500 mg/m2
CarboplatinDrug
Carboplatin AUC 6
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles Receives: Drug: AMG 386 Placebo; Drug: Pemetrexed; Drug: Carboplatin |
| Arm B | Experimental | Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles Receives: Drug: AMG 386; Drug: Pemetrexed; Drug: Carboplatin |
| Arm C | Experimental | Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles Receives: Drug: AMG 386; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Subjects will be evaluated for progression free survival.
Measured: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666977
- Sponsor's protocol ID
- 20101128
- Other IDs
- 2011-001111-31
- Status last verified
- May 2016
- First submitted
- 15 Aug 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01666977
- Acronym / sponsor ID
- 20101128
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Detailed description
To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AMG 386 Placebo, Drug: Pemetrexed, Drug: CarboplatinArm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles |
| Arm B | Experimental | Drug: AMG 386, Drug: Pemetrexed, Drug: CarboplatinArm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles |
| Arm C | Experimental | Drug: AMG 386, Drug: Pemetrexed, Drug: CarboplatinArm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
- Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
- Other criteria may apply
Key exclusion criteria (11 listed)
- Any prior chemotherapy or targeted therapy for non-squamous NSCLC
- Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
- History or presence of central nervous system metastases
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 |
|---|---|---|
| AMG 38615mg/kg | Drug | Arm B |
| AMG 38630 mg/kg | Drug | Arm C |
| AMG 386 PlaceboAMG 386 Placebo | Drug | Arm A |
| PemetrexedPemetrexed 500 mg/m2 | Drug | Arm A, Arm B, Arm C |
| CarboplatinCarboplatin AUC 6 | Drug | Arm A, Arm B, Arm C |
Primary outcome
Progression Free Survival
Time frame: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT
Subjects will be evaluated for progression free survival.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMG 386, Pemetrexed and Carboplatin in people with Non Small Cell Lung Cancer, run by Amgen at 35 sites in 6 countries.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 3 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 35 sites in United States, Australia, Canada, Greece, Spain and 1 more country. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT). 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 3 Jun 2016.