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Stage IV Non-small Cell Lung CancerPhase 2NCT02831491

A Study of Ramucirumab (LY3009806) in Combination With Weekly Docetaxel in Participants With Stage IV Non-Small Cell Lung Cancer

A Phase 2 study testing Ramucirumab and Docetaxel in people with Stage IV Non-small Cell Lung Cancer, run by Eli Lilly and Company.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC) following disease progression after prior platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Non-small Cell Lung Cancer
What is being tested?
Ramucirumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2016to Jan 2018
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant had disease progression on or after prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC.
  • Prior immunotherapy for NSCLC is allowed.
  • The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • The participant has histologically or cytologically confirmed NSCLC.
  • The participant has metastatic NSCLC disease (Stage IV) at the time of first dose of study treatment.
  • The participant has measurable disease at the time of first dose of study treatment documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
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  • The participant has resolution to Grade ≤1 by the National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
  • The participant has adequate organ function.
  • The participant's urine protein is <2+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria ≥2+, then a 24-hour urine must be collected and must demonstrate <2 grams of protein in 24 hours to allow participation in the study.
  • For male participants, are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict), and to not donate sperm starting with the first dose of study treatment, during the study, and for at least 6 months following the last dose of study treatment or country requirements, whichever is longer.
  • For female participants, are surgically sterile, postmenopausal, or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict) during the study and for 6 months following the last dose of study treatment or country requirements, whichever is longer.
  • Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
  • The participant has a life expectancy of ≥3 months.

Who cannot join

  • Prior therapy with docetaxel or ramucirumab.
  • The participant has received more than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC; however, prior maintenance chemotherapy for locally advanced or metastatic NSCLC is allowed.
  • The participant's tumour contains small cell lung cancer.
  • The participant has undergone major surgery within 28 days prior to first dose of study treatment, or subcutaneous venous access device placement within 7 days prior to first dose of study treatment. Furthermore, any participant with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
  • The participant has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
  • The participant has peripheral neuropathy Grade ≥2 (NCI-CTCAE v 4.0).
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  • The participant has an elective or a planned major surgery during the course of the trial.
  • The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
  • The participant has symptomatic, active, or untreated central nervous system (CNS) metastases. Brain metastases that are asymptomatic, stable and not requiring steroid use, and previously treated by radiation are allowed. The participant may have no evidence of Grade ≥1 CNS hemorrhage based on pretreatment MRI or I.V. contrast CT scan (performed within 21 days before first dose of study treatment).
  • The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
  • The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology.
  • The participant has a history of uncontrolled hereditary or acquired thrombotic disorder.
  • The participant is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin (acetylsalicylic acid) use at doses up to 325 milligrams/day is permitted.
  • Participants with a history of gross hemoptysis (defined as bright red blood or ≥1/2 teaspoon) within 2 months prior to first dose of study treatment.
  • The participant has clinically relevant congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
  • The participant has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to first dose of study treatment.
  • The participant has uncontrolled arterial hypertension ≥150 / ≥90 millimeters of mercury despite standard medical management.
  • The participant has had a serious or nonhealing wound, ulcer, or bone fracture ≤28 days prior to first dose of study treatment.
  • The participant has significant bleeding disorders, vasculitis, or experienced Grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of study treatment.
  • History of GI perforation and / or fistulae within 6 months prior to first dose of study treatment.

About this study

Official title: A Single-Arm, Phase 2 Study of Ramucirumab in Combination With Weekly Docetaxel in Patients With Stage IV Non-Small Cell Lung Cancer Following Disease Progression After Prior Platinum-Based Chemotherapy

The main purpose of this study is to evaluate the safety of the study drug ramucirumab in combination with weekly docetaxel in participants with stage IV non-small cell lung cancer (NSCLC) following disease progression after prior platinum-based chemotherapy.

Being tested
Ramucirumab, Docetaxel
Keywords
metastatic
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabDrug

    Also called LY3009806

    Administered IV

  • DocetaxelDrug

    Administered IV

Study groups in NCT02831491
Study groupRoleWhat they receive
Ramucirumab + DocetaxelExperimentalRamucirumab given intravenously (IV) on day 1 every 3 weeks followed by weekly IV infusion of docetaxel on days 1, 8, and 15 every 4 weeks.
Receives: Drug: Ramucirumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Grade ≥3 Neutropenia

    Measured: Baseline through End of Study (Approximately 20 Months)

Secondary outcomes (5)

  1. Rate of Febrile Neutropenia

    Measured: Baseline through End of Study (Approximately 20 Months)

  2. Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response

    Measured: Baseline to Objective Progression or Start of New Anti-Cancer Therapy (Approximately 20 Months)

  3. Progression Free Survival (PFS)

    Measured: Baseline to Objective Progression or Death from Any Cause (Approximately 20 Months)

  4. Overall Survival (OS)

    Measured: Baseline to Date of Death Due to Any Cause (Approximately 20 Months)

  5. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

    Measured: Baseline through End of Study (Approximately 20 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Why it stopped: To pursue broader program objectives in oncology.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831491
Sponsor's protocol ID
16404
Other IDs
I4T-MC-JVDN, 2016-001317-25, 2016
Status last verified
Jun 2020
First submitted
11 Jul 2016
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab and Docetaxel in people with Stage IV Non-small Cell Lung Cancer, run by Eli Lilly and Company.

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 13 inclusion and 20 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: withdrawn, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Percentage of Participants with Grade ≥3 Neutropenia (time frame: Baseline through End of Study (Approximately 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 NCT02831491.

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 Jun 2020.

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