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Small Cell Lung CancerPhase 1NCT02819999

A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Extensive Stage Small Cell Lung Cancer

A Phase 1 study testing Rovalpituzumab Tesirine, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by AbbVie at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC). 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?
Rovalpituzumab Tesirine, Cisplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
11 sitesUnited States
Study dates
Oct 2016to 31 May 2019
Phase
Phase 1
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

  • Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC
  • DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ≥75% of tumor cells.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Minimum life expectancy of at least 12 weeks.
  • Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug.
  • Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR)
  • Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids
  • Use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male

Who cannot join

  • Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC.
  • Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.
  • Documented history of a cerebral vascular, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
  • Recent or ongoing serious infection.
  • Women who are pregnant or breastfeeding.
  • History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
  • Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Colorado

    Aurora, Colorado, 80010

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Texas Oncology

    Fort Worth, Texas, 76104

  • Cancer Institute of Florida

    Orlando, Florida, 32804

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Texas Oncology

    San Antonio, Texas, 78258

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).

Being tested
Rovalpituzumab Tesirine, Cisplatin, Etoposide
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • Rovalpituzumab TesirineDrug

    Also called SC16LD6.5

    Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).

  • CisplatinDrug

  • EtoposideDrug

Study groups in NCT02819999
Study groupRoleWhat they receive
Rovalpituzumab TesirineExperimentalRovalpituzumab Tesirine 0.3 mg/kg IV infusion
Receives: Drug: Rovalpituzumab Tesirine
Rovalpituzumab Tesirine followed by Cisplatin, EtoposideExperimentalRovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion
Receives: Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide
Rovalpituzumab Tesirine with Cisplatin, EtoposideExperimentalCisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion
Receives: Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide
Rovalpituzumab Tesirine following Cisplatin, EtoposideExperimentalCisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion
Receives: Drug: Rovalpituzumab Tesirine; Drug: Cisplatin; Drug: Etoposide

What is being measured

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

  1. Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with DLL3 expressing extensive-stage small cell lung cancer (SCLC)

    For Phase 1a

    Measured: within 21 days after first dose of rovalpituzumab tesirine

  2. Treatment emergent adverse events (TEAEs)

    For Phase 1a

    Measured: through 30 days after last dose of study treatment

  3. Incidence of subjects with CTCAE Grade >2 laboratory abnormalities

    For Phase 1a

    Measured: through 30 days after last dose of study treatment

  4. Progression-Free Survival (PFS)

    For Phase 1b

    Measured: 4 years

Secondary outcomes (21)

  1. Best overall response rate

    Measured: 4 years

  2. Duration of response (DOR)

    Measured: 4 years

  3. Clinical Benefit Rate (CBR)

    Measured: 4 years

  4. Overall Survival (OS)

    Measured: 4 years

  5. Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine

    Measured: 4 years

  6. Progression-free survival (Phase 1a)

    Measured: 4 years

  7. Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed )

    Measured: 4 years

  8. Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval)

    Measured: 4 years

  9. Pharmacokinetic parameters: AUC0-∞ (Area under the curve from time 0 extrapolated to infinity)

    Measured: 4 years

  10. Pharmacokinetic parameters: Tmax (Time of Cmax)

    Measured: 4 years

  11. Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough)

    Measured: 4 years

  12. Pharmacokinetic parameters: T1/2 (Terminal half-life)

    Measured: 4 years

  13. Pharmacokinetic parameters: CL (Clearance)

    Measured: 4 years

  14. Pharmacokinetic parameters: Vss (Volume of distribution at steady state)

    Measured: 4 years

  15. Incidence of TEAEs

    For Phase 1b

    Measured: 4 years

  16. Changes in vital signs (Heart Rate)

    Measured: 4 years

  17. Changes in vital signs (Blood pressure)

    Measured: 4 years

  18. Changes in vital signs (Temperature)

    Measured: 4 years

  19. Changes in vital signs (Weight)

    Measured: 4 years

  20. Changes in vital signs (Respirations)

    Measured: 4 years

  21. Eastern Cooperative Oncology Group (ECOG) score

    Measured: 4 years

Timeline

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

  1. First posted30 Jun 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02819999
Sponsor's protocol ID
SCRX001-004
Status last verified
Jun 2019
First submitted
27 Jun 2016
Last updated
12 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rovalpituzumab Tesirine, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by AbbVie at 11 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 8 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: stopped early, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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.

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 stopped early (reason given: Strategic considerations). Results are not available in the source record.

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?

Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with DLL3 expressing extensive-stage small cell lung cancer (SCLC) (time frame: within 21 days after first dose of rovalpituzumab tesirine). The study lists 4 primary outcomes in all. 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 NCT02819999.

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 12 Mar 2020.

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