Carcinoma, Non-Small-Cell LungNEPTUNNCT02799862
Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by iOMEDICO AG at 1 site in Germany.
Trial summary
This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and quality of life (QoL) in patients with advanced NSCLC receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Nab-Paclitaxel and Carboplatin
- How many people
- 408 participants
- Where
- 1 siteGermany
- Study dates
- 29 Aug 2016to 6 Jun 2021
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with locally advanced / metastatic NSCLC who are not candidates for potentially curative surgery and / or radiation therapy
Who may be able to join
- Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC
- According to SmPC
Who cannot join
- According to SmPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Study of Nab-paclitaxel (Abraxane®) in Combination With Carboplatin as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NEPTUN)
This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and quality of life (QoL) in patients with advanced NSCLC receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.
Read the detailed description
The present NIS is designed to provide additional knowledge in terms of effectiveness, safety and quality of life in routine administration of the combination of nab-paclitaxel (Abraxane®) and carboplatin as first line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for potentially curative surgery and / or radiation therapy. The combination of Abraxane® and carboplatin has been approved in Europe in March 2015 based on results from a pivotal randomized, open label phase III study with 1,052 patients.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Nab-Paclitaxel, Carboplatin
- Keywords
- metastatic, locally advanced, unresectable, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-PaclitaxelDrug
Also called Abraxane
Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
CarboplatinDrug
Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) rate
Effectiveness in terms of PFS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). Additional survival and and if applicable clinical PFS will be followed up for 24 months post-treatment observation.
Measured: After 6-months
Secondary outcomes (5)
Median Overall Survival (OS)
Effectiveness in terms of OS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).
Measured: After 6-months
Overall Response Rate (ORR)
Effectiveness in terms of ORR will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months).
Measured: After 6-months
Safety - Adverse events (AEs)
Safety assessments will consist of monitoring of all AEs, including serious adverse events, and monitoring of laboratory values. AEs will be graded according to CTCAE V4.03. Supportive therapies will be documented.
Measured: through study completion, an average of 9 months
Patient-reported outcomes on Quality of Life
Questionnaires: EQ5D-5L and FACT-L
Measured: Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months
Rationale for physicians' treatment decision
Rationale for physicians' treatment decision, assessed with a therapy-decision questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start29 Aug 2016
- Primary completion7 Dec 2019
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Tobias Dechow, Prof. Dr., Principal investigator, Oncology Ravensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799862
- Sponsor's protocol ID
- IOM-110333
- Acronym
- NEPTUN
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
van Warmerdam LJ, Rodenhuis S, ten Bokkel Huinink WW, Maes RA, Beijnen JH. The use of the Calvert formula to determine the optimal carboplatin dosage. J Cancer Res Clin Oncol. 1995;121(8):478-86. doi: 10.1007/BF01218365.
PubMed 7642691Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
PubMed 22547591Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Reck M, Popat S, Reinmuth N, De Ruysscher D, Kerr KM, Peters S; ESMO Guidelines Working Group. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii27-39. doi: 10.1093/annonc/mdu199. Epub 2014 Aug 11. No abstract available.
PubMed 25115305Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001 Sep;37(13):1590-8. doi: 10.1016/s0959-8049(01)00171-x.
PubMed 11527683Dechow T, Riera-Knorrenschild J, Hackanson B, Janssen J, Schulz H, Oppermann U, Chiabudini M, von Weikersthal LF, Budweiser S, Nacke A, Taeuscher D, Welslau M, Potthoff K. First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Final results of the NEPTUN study. Int J Cancer. 2023 Jul 1;153(1):141-152. doi: 10.1002/ijc.34467. Epub 2023 Mar 8.
PubMed 36757197
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Nab-paclitaxel (Abraxane®) in Combination With Carboplatin as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NEPTUN)
- ClinicalTrials.gov ID
- NCT02799862
- Acronym / sponsor ID
- NEPTUN / IOM-110333
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- metastatic, locally advanced, unresectable, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 15 Jun 2016 (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.
This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and quality of life (QoL) in patients with advanced NSCLC receiving the combination of nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.
Detailed description
The present NIS is designed to provide additional knowledge in terms of effectiveness, safety and quality of life in routine administration of the combination of nab-paclitaxel (Abraxane®) and carboplatin as first line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for potentially curative surgery and / or radiation therapy. The combination of Abraxane® and carboplatin has been approved in Europe in March 2015 based on results from a pivotal randomized, open label phase III study with 1,052 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with locally advanced / metastatic NSCLC who are not candidates for potentially curative surgery and / or radiation therapy
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of locally advanced / metastatic, unresectable NSCLC
- According to SmPC
Key exclusion criteria (1 listed)
- According to SmPC
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 |
|---|---|---|
| Nab-PaclitaxelAlso: AbraxaneNab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel. | Drug | – |
| CarboplatinCarboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel. | Drug | – |
Primary outcome
Progression Free Survival (PFS) rate
Time frame: After 6-months
Effectiveness in terms of PFS will be assessed and evaluated according to local medical standards from screening until end of treatment observation (6 months). Additional survival and and if applicable clinical PFS will be followed up for 24 months post-treatment observation.
5 secondary outcomes
Median Overall Survival (OS)
Time frame: After 6-months
Overall Response Rate (ORR)
Time frame: After 6-months
Safety - Adverse events (AEs)
Time frame: through study completion, an average of 9 months
Patient-reported outcomes on Quality of Life
Time frame: Baseline, after 6 weeks, after 3 months, every 3 months throughout study completion, an average of 9 months
Rationale for physicians' treatment decision
Time frame: Baseline
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 6 Oct 2021.
- Background: PubMed 7642691van Warmerdam LJ, Rodenhuis S, ten Bokkel Huinink WW, Maes RA, Beijnen JH. The use of the Calvert formula to determine the optimal carboplatin dosage. J Cancer Res Clin Oncol. 1995;121(8):478-86. doi: 10.1007/BF01218365.
- Background: PubMed 22547591Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
- Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Background: PubMed 25115305Reck M, Popat S, Reinmuth N, De Ruysscher D, Kerr KM, Peters S; ESMO Guidelines Working Group. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014 Sep;25 Suppl 3:iii27-39. doi: 10.1093/annonc/mdu199. Epub 2014 Aug 11. No abstract available.
- Background: PubMed 11527683Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001 Sep;37(13):1590-8. doi: 10.1016/s0959-8049(01)00171-x.
- Derived from this study: PubMed 36757197Dechow T, Riera-Knorrenschild J, Hackanson B, Janssen J, Schulz H, Oppermann U, Chiabudini M, von Weikersthal LF, Budweiser S, Nacke A, Taeuscher D, Welslau M, Potthoff K. First-line nab-paclitaxel plus carboplatin for patients with advanced non-small cell lung cancer: Final results of the NEPTUN study. Int J Cancer. 2023 Jul 1;153(1):141-152. doi: 10.1002/ijc.34467. Epub 2023 Mar 8.
- Individual participant dataSharing planned: No
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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.
Tobias Dechow, Prof. Dr. principal investigator
Oncology Ravensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by iOMEDICO AG at 1 site in Germany.
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 2 inclusion and 1 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Progression Free Survival (PFS) rate (time frame: After 6-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 NCT02799862, which also lists 6 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 6 Oct 2021.