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TerminatedNCT02819999Updated Mar 12, 2020

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

A Phase 1 interventional study of Rovalpituzumab Tesirine and Cisplatin in Small Cell Lung Cancer, sponsored by AbbVie. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Why this study was terminated
Strategic considerations
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Rovalpituzumab Tesirine

    Rovalpituzumab Tesirine 0.3 mg/kg IV infusion

    Drug: Rovalpituzumab Tesirine

  • Experimental
    Rovalpituzumab Tesirine followed by Cisplatin, Etoposide

    Rovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion

    Drug: Rovalpituzumab Tesirine · Drug: Cisplatin · Drug: Etoposide

  • Experimental
    Rovalpituzumab Tesirine with Cisplatin, Etoposide

    Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion

    Drug: Rovalpituzumab Tesirine · Drug: Cisplatin · Drug: Etoposide

  • Experimental
    Rovalpituzumab Tesirine following Cisplatin, Etoposide

    Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion

    Drug: Rovalpituzumab Tesirine · Drug: Cisplatin · Drug: Etoposide

Interventions

  • DrugRovalpituzumab Tesirine

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

    Also known as: SC16LD6.5

  • DrugCisplatin
  • DrugEtoposide
06

What researchers measure

Primary outcomes

  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

    Time frame: within 21 days after first dose of rovalpituzumab tesirine

  2. Treatment emergent adverse events (TEAEs)

    For Phase 1a

    Time frame: through 30 days after last dose of study treatment

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

    For Phase 1a

    Time frame: through 30 days after last dose of study treatment

  4. Progression-Free Survival (PFS)

    For Phase 1b

    Time frame: 4 years

Secondary outcomes

  1. Best overall response rate

    Time frame: 4 years

  2. Duration of response (DOR)

    Time frame: 4 years

  3. Clinical Benefit Rate (CBR)

    Time frame: 4 years

  4. Overall Survival (OS)

    Time frame: 4 years

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

    Time frame: 4 years

  6. Progression-free survival (Phase 1a)

    Time frame: 4 years

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

    Time frame: 4 years

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

    Time frame: 4 years

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

    Time frame: 4 years

  10. Pharmacokinetic parameters: Tmax (Time of Cmax)

    Time frame: 4 years

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

    Time frame: 4 years

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

    Time frame: 4 years

  13. Pharmacokinetic parameters: CL (Clearance)

    Time frame: 4 years

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

    Time frame: 4 years

  15. Incidence of TEAEs

    For Phase 1b

    Time frame: 4 years

  16. Changes in vital signs (Heart Rate)

    Time frame: 4 years

  17. Changes in vital signs (Blood pressure)

    Time frame: 4 years

  18. Changes in vital signs (Temperature)

    Time frame: 4 years

  19. Changes in vital signs (Weight)

    Time frame: 4 years

  20. Changes in vital signs (Respirations)

    Time frame: 4 years

  21. Eastern Cooperative Oncology Group (ECOG) score

    Time frame: 4 years

07

Study locations

11 sites
  • University of Colorado
    Aurora, Colorado 80010, United States
  • Rocky Mountain Cancer Centers
    Denver, Colorado 80218, United States
  • Cancer Institute of Florida
    Orlando, Florida 32804, United States
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland 21231, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Oncology Hematology Care
    Cincinnati, Ohio 45242, United States
  • University Hospital of Cleveland
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15232, United States
  • Texas Oncology
    Fort Worth, Texas 76104, United States
  • Texas Oncology
    San Antonio, Texas 78258, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02819999
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Oct 2016
Primary completion
May 31, 2019
Completion
May 31, 2019
Last update
Mar 12, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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