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Small Cell Lung CancerPhase 3NCT03334487

Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

A Phase 3 study testing Dexamethasone and Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 60 sites in 7 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Dexamethasone and Rovalpituzumab tesirine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
60 sitesin 7 countries
Study dates
15 Mar 2018to 20 Dec 2018
Phase
Phase 3
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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum life expectancy of at least 12 weeks.
  • Laboratory values meeting the criteria specified in the protocol.
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
  • Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
  • Measurable disease as described per protocol.
  • In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.

Who cannot join

  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug.
  • Recent or on-going serious infection.
  • History of other invasive malignancy that has not been in remission for at least 3 years.
  • History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
  • Documented history of capillary leak syndrome.
  • Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.

Trial locations and contacts

60 sites in 7 countries.

60 sites in 7 countries

United States27 sites

  • VCS, Virginia Cancer Specialis /ID# 169760

    Arlington, Virginia, 22031

  • Univ of Colorado Cancer Center /ID# 200810

    Aurora, Colorado, 80045

  • Sandra Malcolm Berman Cncr Ins /ID# 171346

    Baltimore, Maryland, 21204

  • St. Luke's Hematology Oncology /ID# 171378

    Bethlehem, Pennsylvania, 18015

  • Boca Raton Regional Hospital /ID# 200168

    Boca Raton, Florida, 33486

  • Ironwood Cancer & Res Ctr /ID# 171335

    Chandler, Arizona, 85224-5665

  • The Ohio State University Comp /ID# 171352

    Columbus, Ohio, 43210

  • UMHC/Sylvester Comprehensive /ID# 171462

    Deerfield Beach, Florida, 33442

  • St. Luke's University Hospital /ID# 171374

    Duluth, Minnesota, 55802

  • VA Central California Health C /ID# 170951

    Fresno, California, 93703

  • Kadlec Clinic Hematology and O /ID# 169797

    Kennewick, Washington, 99336

  • Baptist Health /ID# 171379

    Lexington, Kentucky, 40503-1463

  • Loma Linda University Medical /ID# 171377

    Loma Linda, California, 92354

  • Norton Cancer Institute /ID# 200827

    Louisville, Kentucky, 40202-3700

  • Mount Sinai Comp Cancer Ctr /ID# 169759

    Miami, Florida, 33140

  • Tennessee Oncology PLLC: Sarah /ID# 171380

    Nashville, Tennessee, 37203

  • Vanderbilt Ingram Henry Cancer /ID# 171356

    Nashville, Tennessee, 37212

  • Tulane Cancer Center Clinic /ID# 171376

    New Orleans, Louisiana, 70112

  • UC Irvine Health /ID# 171343

    Orange, California, 92868-3201

  • Illinois Cancer Care, PC /ID# 171310

    Peoria, Illinois, 61615

  • Kaiser Permanente - Roseville /ID# 200779

    Roseville, California, 95661-3027

  • Kaiser Permanente-Santa Clara /ID# 203024

    Santa Clara, California, 95051-5173

  • Mayo Clinic - Scottsdale /ID# 171359

    Scottsdale, Arizona, 85259

  • Kaiser Permanente Medical Ctr-Vallejo /ID# 169758

    Vallejo, California, 94589-2441

  • Kaiser Permanente- Walnut Creek /ID# 201305

    Walnut Creek, California, 94596

  • Valley Hospital - Westwood, NJ /ID# 171357

    Westwood, New Jersey, 07675

  • Wake Forest Baptist Medical Center /ID# 169799

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Brazil8 sites

  • Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 200496

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Sao Lucas da PUCRS /ID# 201258

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Inca /Id# 202594

    Rio de Janeiro, 20231-050

  • Instituto COI de Educacao e Pe /ID# 200499

    Rio de Janeiro, 22793-080

  • Bahia Oncology Center - NOB /ID# 201272

    Salvador, Estado de Bahia, 40170-110

  • Icesp /Id# 201036

    São Paulo, São Paulo, 01246-000

  • Fundacao Antonio Prudente /ID# 200218

    São Paulo, 01509-000

  • Hospital de Cancer de Barretos /ID# 200104

    São Paulo, 14784-400

Other trials in Brazil

Germany7 sites

  • Charite Universitatsmedizin B- /ID# 170079

    Berlin, 13353

  • Asklepios Fachkliniken M. Gaut /ID# 170081

    Gauting, 82131

  • Franziskus-Hospital Harderberg /ID# 201145

    Georgsmarienhütte, Lower Saxony, 49124

  • Thoraxklinik Heidelberg gGmbH /ID# 170078

    Heidelberg, 69126

  • Klinikum Kassel - Onkologie /ID# 170083

    Kassel, 34125

  • Universitatsklinikum Munster /ID# 170087

    Münster, 48149

  • Pius Hospital Oldenburg /ID# 170080

    Oldenburg, 26121

Other trials in Germany

Australia6 sites

  • Coffs Harbour Health Campus /ID# 200642

    Coffs Harbour, New South Wales, 2450

  • The Townsville Hospital /ID# 200640

    Douglas, Queensland, 4814

  • Austin Hospital /ID# 200639

    Heidelberg, Victoria, 3084

  • Perron Institute for Neurological and Translational Science /ID# 200644

    Nedlands, Western Australia, 6009

  • The Tweed Hospital /ID# 200646

    Tweed Heads, New South Wales, 2485

  • Border Medical /ID# 200645

    Wodonga, Victoria, 3690

Other trials in Australia

Sweden5 sites

  • Gavle Hospital /ID# 171253

    Gävle, 801 88

  • University Hospital Linkoping /ID# 201666

    Linköping, 58185

  • Karolinska University Hospital /ID# 201967

    Stockholm, SE-17176

  • Norrlands Universitetssjukhus /ID# 171250

    Umeå, 90185

  • Akademiska Sjukhuset /ID# 171248

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Canada4 sites

  • Tom Baker Cancer Centre /ID# 171561

    Calgary, Alberta, T2N 4N2

  • QE II Health Sciences Centre /ID# 171569

    Halifax, Nova Scotia, B3H 1V7

  • London Health Sciences Centre /ID# 171567

    London, Ontario, N6A 5A5

  • The Ottawa Hospital /ID# 200682

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

United Kingdom3 sites

  • Leicester Royal Infirmary /ID# 201154

    Leicester, England, LE1 5WW

  • Christie NHS Foundation Trust /ID# 201149

    Manchester, M20 4BX

  • Royal Preston Hospital /ID# 201146

    Preston, PR2 9HT

Other trials in United Kingdom

About this study

Official title: Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer

A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).

Being tested
Dexamethasone, Rovalpituzumab tesirine
Keywords
Cancer, Small Cell Lung Cancer, Relapsed Small Cell Lung Cancer, Remitting Small Cell Lung Cancer, Delta-like protein 3 (DLL3), DLL3 Expressing Small Cell Lung Cancer, Rovalpituzumab Tesirine
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

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

  • DexamethasoneDrug

    Oral

  • Rovalpituzumab tesirineDrug

    Also called SC16LD6.5

    Intravenous

Study groups in NCT03334487
Study groupRoleWhat they receive
Rovalpituzumab tesirine + dexamethasoneExperimentalRovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
Receives: Drug: Dexamethasone; Drug: Rovalpituzumab tesirine

What is being measured

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

  1. Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE

    Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: Approximately 32 months

Secondary outcomes (7)

  1. Change in Participant Reported Outcome EORTC QLQC15-PAL

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical \& emotional functioning, fatigue and pain) along with 6 individual items (nausea \& vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life).

    Measured: Approximately 32 months

  2. Progression Free Survival (PFS)

    PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.

    Measured: Approximately 32 months

  3. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.

    Measured: Approximately 32 months

  4. Objective response rate (ORR)

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Approximately 32 months

  5. Change in EORTC QLQ-LC-13

    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients.

    Measured: Approximately 32 months

  6. Duration of Objective Response (DOR)

    DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first.

    Measured: Approximately 32 months

  7. Clinical Benefit Rate (CBR)

    CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.

    Measured: Approximately 32 months

Timeline

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

  1. First posted7 Nov 2017
  2. Study start15 Mar 2018
  3. Primary completion20 Dec 2018
  4. Study completion20 Dec 2018

Why it stopped: Strategic considerations

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 3
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
NCT03334487
Sponsor's protocol ID
M16-292
Other IDs
2017-003173-33, 2017
Status last verified
Dec 2018
First submitted
3 Nov 2017
Last updated
26 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone and Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 60 sites in 7 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 7 inclusion and 7 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Brazil, Germany, Australia, Sweden and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE (time frame: Approximately 32 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 NCT03334487.

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 26 Dec 2018.

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