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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03098030




Registration number
NCT03098030
Ethics application status
Date submitted
22/03/2017
Date registered
31/03/2017

Titles & IDs
Public title
Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
Scientific title
A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Secondary ID [1] 0 0
DIV-SCLC-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dinutuximab
Treatment: Drugs - Irinotecan
Treatment: Drugs - Topotecan

Experimental: Part 1: Dinutuximab + Irinotecan - Dinutuximab (10 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV.

Active comparator: Part 2: Irinotecan - Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle.

Experimental: Part 2: Dinutuximab + Irinotecan - Dinutuximab (16 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV.

Active comparator: Part 2: Topotecan - Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle.


Treatment: Other: Dinutuximab
Dinutuximab injection, for intravenous (IV) use

Treatment: Drugs: Irinotecan
Irinotecan injection, IV infusion

Treatment: Drugs: Topotecan
Topotecan for injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 2.5 years
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
Up to approximately 2.5 years

Eligibility
Key inclusion criteria
1. Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).
2. Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
3. Have no curative therapy available.
4. Have a life expectancy of at least 12 weeks.
5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Have adequate bone marrow and hepatic function.
7. Have calculated creatinine clearance (CrCL) =30 mL/minute or serum creatinine =1.5 times below the upper limit of normal.
8. Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment.
9. Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Candidate for re-treatment with original platinum-based regimen as second-line therapy.
2. Prior treatment with irinotecan, topotecan, or dinutuximab.
3. Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation.
4. Have mixed small cell and non-small cell histologic features.
5. Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago.
6. Have a history or current evidence of uncontrolled cardiovascular disease.
7. Have not recovered from prior surgery, significant trauma, systemic anticancer therapy, radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
8. Have had organ allograft or hematopoietic transplantation.
9. Known to be human immunodeficiency virus (HIV) positive.
10. Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
11. Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
12. Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
13. Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2020
Sample size
Target
Accrual to date
Final
483
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Mid North Coast Cancer Institute Coff Habour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Mater Misericordiae Limited and Mater Medical Research Institute Limited - South Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Ballarat Health Services - Ballarat
Recruitment postcode(s) [1] 0 0
NSW 2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alaska
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Arizona
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Arkansas
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California
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Connecticut
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Georgia
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Indiana
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Iowa
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Kentucky
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Missouri
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Oregon
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South Carolina
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South Dakota
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Tennessee
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West Virginia
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Wisconsin
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Bulgaria
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Blagoevgrad
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Burgas
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Dobrich
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Gabrovo
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Bulgaria
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Panagyurishte
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Pleven
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Sofia
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Strasbourg
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Batumi
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Tbilisi
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Matrahaza
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Miskolc
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Rajasthan
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India
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Bangalore
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India
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Catania
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Incheon
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Namdong
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Ulsan
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Kuala Lumpur
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Quezon City
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Mrozy
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Lódz Voivodeship
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Craiova
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Suceava
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Romania
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Russian Federation
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Arkhangelsk
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Russian Federation
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Kursk
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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Samara
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Russian Federation
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Yaroslavl
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Slovakia
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Bardejov
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Slovakia
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Žilina
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Alicante
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Spain
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Galicia
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Navarra
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Spain
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Barcelona
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Córdoba
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Girona
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Lugo
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Málaga
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Spain
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Ourense
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Spain
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Planta
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Spain
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Sabadell
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Sevilla
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Valencia
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Spain
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Vigo
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Spain
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Zaragoza
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung City
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Taiwan
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Tainan City
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Taiwan
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Taoyuan City
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Phitsanulok
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Thailand
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Songkhla
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Ukraine
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Dnipropetrovsk
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Ukraine
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Zakarpattia
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Ukraine
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Chernivtsi
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Ukraine
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Kiev
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Ukraine
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Odessa
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Ukraine
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Vinnitsya
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United Kingdom
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Essex
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United Kingdom
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London
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United Kingdom
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Leeds
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03098030