Recurrent Small Cell Lung CancerPhase 1/2NCT01901653

Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer

A Phase 1/2 study testing Rovalpituzumab tesirine (SC16LD6.5) in people with Recurrent Small Cell Lung Cancer, run by Stemcentrx at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Small Cell Lung Cancer
What is being tested?: Rovalpituzumab tesirine (SC16LD6.5)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 8 sitesUnited States
Study dates: Jul 2013to 28 Nov 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Provision of informed consent
Male or female ≥18 years of age
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
At least 1 prior regimen must have contained a platinum salt
'Adjuvant therapy' will constitute a prior treatment regimen

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No more than 2 prior regimens are allowed
Measurable disease (only for the phase II portion)
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
A minimum life expectancy of 12 weeks
Adequate bone marrow, hepatic and renal function as evidenced by:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9.0 g/dL
Serum bilirubin < 1.5 x ULN
Aspartate aminotransferase (AST)/Alanine transferase (ALT) (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
Serum creatinine < 1.5 x ULN
No 'active' CNS metastases. Prior CNS metastases are allowed, provided adequate palliative therapy has been administered and CNS disease control has been established prior to study entry.
A brain MRI scan, ≤ 28 days from day 1, is required
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures and who have a negative serum pregnancy test within 1 week prior to initial study treatment. (See Appendix B)
Male patients willing to use adequate contraceptive. (See Appendix B)
At least 21 days must have elapsed prior to day 1 cycle 1, from chemotherapy, radiotherapy, immunotherapy or following major surgery and any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 for "limited palliative radiotherapy", defined as a course of therapy encompassing < 25% total bone marrow volume and not exceeding 30 Gy.
At least 14 days must have elapsed for chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity.

Who cannot join

Patients who are pregnant or breastfeeding.
Active involvement of the Central Nervous System (CNS).
Uncontrolled infection or systemic disease.
Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.
No concurrent systemic chemotherapy or anticancer biologic therapy is allowed. Note: Patients on hormonal treatment for breast cancer or prostate cancer may continue on treatment and enter into study.

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Known hypersensitivity to any components of SC16LD6.5 study drug product.
Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both), a history of solid organ or bone marrow transplantation would generally be considered to have met exclusion criteria, however exceptions may be considered on a case-by-case basis by the medical monitor.
Psychiatric disorder or social or geographic situation that would preclude study participation.
QT interval measurement corrected by Fridericia's formula (QTcF) interval of >450 msec (males) or >470 msec (females)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Chicago Medical Center
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Florida Cancer Specialists
Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: Phase I/II Open Label Dose Escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of SC16LD6.5 as a Single Agent in Patients With Recurrent Small Cell Lung Cancer

The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.

Conditions: Recurrent Small Cell Lung Cancer
Being tested: Rovalpituzumab tesirine (SC16LD6.5)
Keywords: Small cell lung cancer
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 tesirine (SC16LD6.5)Drug

Study groups in NCT01901653
Study group	Role	What they receive
Rovalpituzumab tesirine	Experimental	Rovalpituzumab tesirine will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated on Day 1 of each 21-day or 42-day cycle until either unacceptable toxicity or evidence of disease progression occurs. Receives: Drug: Rovalpituzumab tesirine (SC16LD6.5)

What is being measured

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

Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine
MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).
Measured: The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.

Secondary outcomes (7)

Objective Response Rate (ORR)
Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR).
Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Measured: From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).
Duration of Response (DOR)
Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first.
Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Measured: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).
Clinical Benefit Rate (CBR)
Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders.
Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Measured: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study.
Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC).
Measured: From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).
Overall Survival
Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive.
Measured: From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).
Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)
The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle.
Measured: From Day 1 of first dose to End of Dose Cycle
Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC
The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum.
Measured: From Day 1 of first dose to End of Dose Cycle

Timeline

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

Jul 201328 Nov 2016

First posted17 Jul 2013 (estimated)
Study startJul 2013
Primary completion28 Nov 2016
Study completion28 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Recurrent Small Cell Lung CancerStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01901653
Sponsor's protocol ID: SCRX16-001
Status last verified: Jul 2018
First submitted: 11 Jul 2013
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rudin CM, Pietanza MC, Bauer TM, Ready N, Morgensztern D, Glisson BS, Byers LA, Johnson ML, Burris HA 3rd, Robert F, Han TH, Bheddah S, Theiss N, Watson S, Mathur D, Vennapusa B, Zayed H, Lally S, Strickland DK, Govindan R, Dylla SJ, Peng SL, Spigel DR; SCRX16-001 investigators. Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study. Lancet Oncol. 2017 Jan;18(1):42-51. doi: 10.1016/S1470-2045(16)30565-4. Epub 2016 Dec 5.
PubMed 27932068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Open Label Dose Escalation Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of SC16LD6.5 as a Single Agent in Patients With Recurrent Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT01901653
Acronym / sponsor ID: SCRX16-001
Conditions: Recurrent Small Cell Lung Cancer
Keywords: Small cell lung cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: StemcentrxIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: 28 Nov 2016 (actual)
Study completion: 28 Nov 2016 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 11 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rovalpituzumab tesirine	Experimental	Drug: Rovalpituzumab tesirine (SC16LD6.5)Rovalpituzumab tesirine will be administered as a single agent, at increasing dose levels as permitted based on real-time assessment of safety and tolerability, intravenously over 30 minutes. Doses will be repeated on Day 1 of each 21-day or 42-day cycle until either unacceptable toxicity or evidence of disease progression occurs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Provision of informed consent
Male or female ≥18 years of age
Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
Measurable disease (only for the phase II portion)

Key exclusion criteria (10 listed)

Patients who are pregnant or breastfeeding.
Active involvement of the Central Nervous System (CNS).
Uncontrolled infection or systemic disease.
Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Chemotherapy regimens within the last 21 days (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens, biologic, and targeted therapy given continuously or on a weekly basis with limited potential for delayed toxicity within the last 14 days.

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
Rovalpituzumab tesirine (SC16LD6.5)	Drug	Rovalpituzumab tesirine

Primary outcome

Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine
Time frame: The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.
MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).

7 secondary outcomes

Objective Response Rate (ORR)
Time frame: From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).
Duration of Response (DOR)
Time frame: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).
Clinical Benefit Rate (CBR)
Time frame: From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).
Progression-free Survival (PFS)
Time frame: From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).
Overall Survival
Time frame: From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).
Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)
Time frame: From Day 1 of first dose to End of Dose Cycle
Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC
Time frame: From Day 1 of first dose to End of Dose Cycle

Results and safety

Results posted to the registry on 11 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC)	3	0
Phase 1a: Cohort 2 (SCLC)	1	0
Phase 1a: Cohort 3 (SCLC)	11	0
Phase 1a: Cohort 4 (SCLC)	3	0
Phase 1a: Cohort 5 (SCLC)	2	0
Phase 1a: Cohort 6 (SCLC)	3	0
Phase 1a: Cohort 7 (SCLC)	7	0
Phase 1a: Cohort 8 (SCLC)	10	0
Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC)	1	0
Phase 1b: Retreatment (SCLC)	18	0
Phase 1b: Retreatment (LCNEC)	2	0
Phase 1b: Maintenance (SCLC)	16	0
Phase 1b: Maintenance (LCNEC)	5	0

Primary outcome: Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine

Time frame: The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.. Number. Unit: mg/kg

Measure	Rovalpituzumab Tesirine n = 41
Value	0.4

Population analysed: All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first dose through 30-days following last dose (on average 85 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1a: Cohort 1 (SCLC)	0 of 3 (0%)	3 of 3 (100%)	Not reported
Phase 1a: Cohort 2 (SCLC)	0 of 1 (0%)	1 of 1 (100%)	Not reported
Phase 1a: Cohort 3 (SCLC)	3 of 11 (27.3%)	11 of 11 (100%)	Not reported
Phase 1a: Cohort 4 (SCLC)	3 of 3 (100%)	3 of 3 (100%)	Not reported
Phase 1a: Cohort 5 (SCLC)	2 of 2 (100%)	2 of 2 (100%)	Not reported
Phase 1a: Cohort 6 (SCLC)	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Phase 1a: Cohort 7 (SCLC)	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
Phase 1a: Cohort 8 (SCLC)	4 of 10 (40%)	10 of 10 (100%)	Not reported
Phase 1a: Cohort 8 (LCNEC)	1 of 1 (100%)	1 of 1 (100%)	Not reported
Phase 1b: Retreatment (SCLC)	7 of 18 (38.9%)	18 of 18 (100%)	Not reported
Phase 1b: Retreatment (LCNEC)	1 of 2 (50%)	2 of 2 (100%)	Not reported
Phase 1b: Maintenance (SCLC)	5 of 16 (31.3%)	15 of 16 (93.8%)	Not reported
Phase 1b: Maintenance (LCNEC)	4 of 5 (80%)	5 of 5 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27932068Rudin CM, Pietanza MC, Bauer TM, Ready N, Morgensztern D, Glisson BS, Byers LA, Johnson ML, Burris HA 3rd, Robert F, Han TH, Bheddah S, Theiss N, Watson S, Mathur D, Vennapusa B, Zayed H, Lally S, Strickland DK, Govindan R, Dylla SJ, Peng SL, Spigel DR; SCRX16-001 investigators. Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study. Lancet Oncol. 2017 Jan;18(1):42-51. doi: 10.1016/S1470-2045(16)30565-4. Epub 2016 Dec 5.

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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.

Donald Strickland, MD study director

SCRI Innovations

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rovalpituzumab tesirine (SC16LD6.5) in people with Recurrent Small Cell Lung Cancer, run by Stemcentrx at 8 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 23 inclusion and 10 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 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?

Yes. Results are posted in the registry (first posted 11 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine (time frame: The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.). 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 NCT01901653, which also lists 1 linked publication.

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 Aug 2018.