Metastatic Small Cell Lung CancerPhase 2NCT02200757

Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

A Phase 2 study testing Aldoxorubicin and Topotecan in people with Metastatic Small Cell Lung Cancer, run by ImmunityBio, Inc. at 29 sites in 3 countries.

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

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Small Cell Lung Cancer
What is being tested?: Aldoxorubicin and Topotecan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 29 sitesin 3 countries
Study dates: 20 Apr 2015to 15 May 2017
Phase: Phase 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

Age ≥18 years male or female.
Histological confirmation of SCLC.
Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
Capable of providing informed consent and complying with trial procedures.
ECOG PS 0-2.
Life expectancy >8 weeks.

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Measurable tumor lesions according to RECIST 1.1 criteria.[22]
Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Who cannot join

Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
Prior treatment with topotecan.
Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
Exposure to any investigational agent within 30 days of date of randomization.
Exposure to any systemic chemotherapy within 21 days of date of randomization.
Active (symptomatic) central nervous system (CNS) metastasis.

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History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.
Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.
Anion gap > 16 meq/L or arterial blood pH < 7.30.
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
Baseline QTc >470 msec measured by Fridericia's formula (QTcF) and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed.
History or signs of active coronary artery disease with angina pectoris within the last 6 months.
Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
Known history of HIV infection.
Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
Major surgery within 30 days prior to date of randomization.
Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
Any condition that is unstable and could jeopardize the subject's participation in the study.

Trial locations and contacts

29 sites in 3 countries.

Country

City, postcode or hospital

29 sites in 3 countries

Spain12 sites

Hospital General Universitario de Alicante
Alicante
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Universitario Quiron-Dexeus (IOR)
Barcelona
University Hospital Vall d'Hebron
Barcelona
Hospital Universitario Lucus Augusti
Lugo
General University Hospital Gregorio Maranon
Madrid
Hospital Puerta de Hierro
Madrid
University Hospital Foundation Jimenez Diaz
Madrid
University Hospital La Paz
Madrid
Hospital Regional Universitario
Málaga
University Hospital Virgen de Valme
Seville
CHU Xeral
Vigo

Other trials in Spain

United States11 sites

Tennessee Oncology
Chattanooga, Tennessee, 37404
Oncology Hermatology Care, Inc.
Cincinnati, Ohio, 45242
Cancer Specialists of North Florida-Fleming Island
Fleming Island, Florida
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Cedars-Sinai Medical Center
Los Angeles, California, 90048
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
City of Hope Medical Group
Pasadena, California, 91030
Northwest CCOP Kaiser Permanente
Portland, Oregon, 97227

Other trials in United States

Hungary6 sites

Koranyi National Institute of TBC and Pulmonologyhhy
Budapest
Koranyi National Institute of TBC and Pulmonology
Budapest
University of Debrecen, Medical and Health Science Center, Department of Pulmonology
Debrecen
Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology
Nyíregyháza
Medical Center of the University of Pecs, 1st Department of Internal Medicine
Pécs
Hetenyi Geza Hospital
Szolnok

Other trials in Hungary

About this study

Official title: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Conditions: Metastatic Small Cell Lung Cancer
Being tested: Aldoxorubicin, Topotecan
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.

AldoxorubicinDrug
Also called INNO-206
230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
TopotecanDrug
Also called Hycamtin
1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs

Study groups in NCT02200757
Study group	Role	What they receive
Aldoxorubicin	Experimental	Not described Receives: Drug: Aldoxorubicin
Topotecan	Active comparator	Not described Receives: Drug: Topotecan

What is being measured

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

Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
Progressive Disease is defined as: ≥20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥1 new lesion is also considered progression.
Measured: 24 months

Secondary outcomes (1)

Number of Participants With Treatment-related Toxicities (Adverse Events)
Measured: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.

Timeline

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

20 Apr 201515 May 2017

First posted25 Jul 2014 (estimated)
Study start20 Apr 2015
Primary completion15 May 2017
Study completion15 May 2017

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.
Other trials for Metastatic Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200757
Sponsor's protocol ID: ALDOXORUBICIN-P2-SCLC-01
Status last verified: Jan 2016
First submitted: 23 Jul 2014
Last updated: 25 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer

All Metastatic Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
ClinicalTrials.gov ID: NCT02200757
Acronym / sponsor ID: ALDOXORUBICIN-P2-SCLC-01
Conditions: Metastatic Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: ImmunityBio, Inc.Industry (pharma, biotech, devices)
Study start: 20 Apr 2015 (actual)
Primary completion: 15 May 2017 (actual)
Study completion: 15 May 2017 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Posted 25 Jun 2024

Clinical summary

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

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aldoxorubicin	Experimental	Drug: Aldoxorubicin
Topotecan	Active comparator	Drug: Topotecan

Who may qualify

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

Key inclusion criteria (11 listed)

Age ≥18 years male or female.
Histological confirmation of SCLC.
Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
Capable of providing informed consent and complying with trial procedures.
ECOG PS 0-2.

Key exclusion criteria (20 listed)

Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
Prior treatment with topotecan.
Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
Exposure to any investigational agent within 30 days of date of randomization.
Exposure to any systemic chemotherapy within 21 days of date of randomization.

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
AldoxorubicinAlso: INNO-206230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.	Drug	Aldoxorubicin
TopotecanAlso: Hycamtin1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs	Drug	Topotecan

Primary outcome

Progression-Free Survival (PFS)
Time frame: 24 months
PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression. Progressive Disease is defined as: ≥20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥1 new lesion is also considered progression.

1 secondary outcome

Number of Participants With Treatment-related Toxicities (Adverse Events)
Time frame: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.

Results and safety

Results posted to the registry on 25 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aldoxorubicin	67	67
Topotecan	63	63

Primary outcome: Progression-Free Survival (PFS)

Time frame: 24 months. Median (95% Confidence Interval). Unit: Months

Measure	Aldoxorubicin n = 69	Topotecan n = 66
Value	1.5 (1.4 to 2.7)	2.7 (1.5 to 3.0)

Population analysed: PFS is measured from randomization, not from treatment start date. 2 subjects were randomized, but not treated in the Aldoxorubicin Arm. 3 subjects were randomized, but not treated in the Topotecan Arm.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All AEs and SAEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until 30 days after the last dose of study medication, up to 451 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aldoxorubicin	17 of 67 (25.4%)	61 of 67 (91%)	57 of 69
Topotecan	18 of 63 (28.6%)	61 of 63 (96.8%)	50 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer

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.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aldoxorubicin and Topotecan in people with Metastatic Small Cell Lung Cancer, run by ImmunityBio, Inc. at 29 sites in 3 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 11 inclusion and 20 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain, United States, Hungary. 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 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 25 Jun 2024). 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?

Progression-Free Survival (PFS) (time frame: 24 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 NCT02200757.

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 25 Jun 2024.