Small Cell Lung CancerPhase 3NCT00119613
A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
A Phase 3 study testing darbepoetin alfa in people with Small Cell Lung Cancer, run by Amgen.
Trial summary
The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival. 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?
- darbepoetin alfa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Apr 2007
- Phase
- Phase 3
- 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
- Pathologically proven SCLC, extensive-stage
- Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than or equal to 3 months
- Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL
- Adequate renal, liver and hematopoietic function
- Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form
Who cannot join
- Known primary hematologic disorder which could cause anemia
- Brain metastases that are either symptomatic or treated with medications
- Unstable or uncontrolled disease/condition, related to or affecting cardiac function
- Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies
- Iron deficiency
- Known positive test for human immunodeficiency virus infection
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- Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization
- Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
- Previous chemotherapy for SCLC
- Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely
- Less than 30 days since receipt of any drug or device that is not approved for any indication
- Pregnant or breast-feeding
- Not using adequate contraceptive precautions
- Previously randomized into this study
- Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug
- Any medical, mental, or other conditions that makes the subject unsuitable for participation
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
- Conditions
- Small Cell Lung Cancer
- Being tested
- placebo, darbepoetin alfa
- Keywords
- Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide, Extensive Stage Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo
darbepoetin alfaDrug
darbepoetin alfa
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - darbepoetin alfa | Experimental | Darbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period. Receives: Drug: darbepoetin alfa |
| Group 2 - Placebo | Placebo comparator | Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
Measured: from baseline to the end of the chemotherapy treatment period
Survival time
Secondary outcomes (3)
Change in FACT-fatigue subscale scores from baseline to the end of study treatment
Measured: from baseline to the end of study treatment
Incidence of Adverse Events (including serious and treatment related)
Measured: Throughout study
Changes in laboratory values, changes in vital signs and incidence of concomitant medications
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startDec 2002
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119613
- Sponsor's protocol ID
- 20010145
- Status last verified
- Aug 2008
- First submitted
- 7 Jul 2005
- Last updated
- 8 Aug 2008
- Results posted
- No
Publications
Pirker R, Ramlau RA, Schuette W, Zatloukal P, Ferreira I, Lillie T, Vansteenkiste JF. Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. J Clin Oncol. 2008 May 10;26(14):2342-9. doi: 10.1200/JCO.2007.15.0748.
PubMed 18467726Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.
PubMed 39113428Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
PubMed 36184621
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
- ClinicalTrials.gov ID
- NCT00119613
- Acronym / sponsor ID
- 20010145
- Conditions
- Small Cell Lung Cancer
- Keywords
- Oncology, Clinical Trial, Hemoglobin, Darbepoetin alfa, Survival, Carboplatin, Cisplatin, Etoposide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
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 whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - darbepoetin alfa | Experimental | Drug: darbepoetin alfaDarbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period. |
| Group 2 - Placebo | Placebo comparator | Drug: placeboPlacebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically proven SCLC, extensive-stage
- Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than or equal to 3 months
- Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL
Key exclusion criteria (16 listed)
- Known primary hematologic disorder which could cause anemia
- Brain metastases that are either symptomatic or treated with medications
- Unstable or uncontrolled disease/condition, related to or affecting cardiac function
- Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies
- Iron deficiency
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 |
|---|---|---|
| placeboplacebo | Drug | Group 2 - Placebo |
| darbepoetin alfadarbepoetin alfa | Drug | Group 1 - darbepoetin alfa |
Primary outcome
Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period
Time frame: from baseline to the end of the chemotherapy treatment period
Survival time
3 secondary outcomes
Change in FACT-fatigue subscale scores from baseline to the end of study treatment
Time frame: from baseline to the end of study treatment
Incidence of Adverse Events (including serious and treatment related)
Time frame: Throughout study
Changes in laboratory values, changes in vital signs and incidence of concomitant medications
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Results publication: PubMed 18467726Pirker R, Ramlau RA, Schuette W, Zatloukal P, Ferreira I, Lillie T, Vansteenkiste JF. Safety and efficacy of darbepoetin alpha in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. J Clin Oncol. 2008 May 10;26(14):2342-9. doi: 10.1200/JCO.2007.15.0748.
- Derived from this study: PubMed 39113428Marzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909.
- Derived from this study: PubMed 36184621Ventz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darbepoetin alfa in people with Small Cell Lung Cancer, run by Amgen.
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 7 inclusion and 16 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 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period (time frame: from baseline to the end of the chemotherapy treatment period). The study lists 2 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 NCT00119613, which also lists 3 linked publications.
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 8 Aug 2008.