AzTrials
AzTrials

Carcinoma, Large CellPhase 4NCT01317615

RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

A Phase 4 study testing RAD001, Paclitaxel and Carboplatin in people with Carcinoma, Large Cell and Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 9 sites in Germany.

Completed

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

Official record
Search all trials

Trial summary

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Large Cell, Neuroendocrine Tumors
What is being tested?
RAD001, Paclitaxel and Carboplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
9 sitesGermany
Study dates
Apr 2011to Mar 2015
Phase
Phase 4
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

  • Patients who give a written informed consent obtained according to local guidelines
  • Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:
  • Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent
  • Relapse must be confirmed by histology
  • Neuroendocrine differentiation
  • World Health organisation (WHO) performance status grade ≤ 1
Show all 10Show fewer
  • measurable disease
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function

Who cannot join

  • History or clinical evidence of central nervous system (CNS) metastases.
  • Presence of SCLC cells
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ, early stages of breast cancer (LCIS and DCIS) and prostate cancer (stage T1a)
  • prior chemotherapy for the treatment of advanced lung cancer and/or not having recovered from the side effects of any other therapy (adjuvant treatment for earlier stages I-III is allowed if finished at least one year before study entry)
  • Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy
  • Patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
Show all 10Show fewer
  • Patients who have received prior therapy with RAD001 or other mTOR inhibitors
  • Having any severe and/or uncontrolled medical conditions
  • Women who are pregnant or breast feeding
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Germany9 sites

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Bremen, 28177

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Hemer, 58675

  • Novartis Investigative Site

    Leipzig, 04177

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

About this study

Official title: A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cancer With Neuroendocrine Differentiation (LC-NEC)

This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

Being tested
RAD001, Paclitaxel, Carboplatin
Keywords
Large cell carcinoma,, Lung cancer,, Neuroendocrine Tumors,, RAD001
Medical subject headings
Carcinoma, Large Cell, Neuroendocrine Tumors, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001Drug

    Also called Everolimus

    Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.

  • PaclitaxelDrug

    Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.

  • CarboplatinDrug

    Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.

Study groups in NCT01317615
Study groupRoleWhat they receive
RAD001 plus paclitaxel/carboplatinExperimentalParticipants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
Receives: Drug: RAD001; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Percentage of Participants Progression-free

    Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

    Measured: 3 months

Secondary outcomes (5)

  1. Percentage of Participants Progression-free

    Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

    Measured: 6 months

  2. Percentage of Participants With Overall Response Rate (ORR)

    ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.

    Measured: 3 months

  3. Percentage of Participants With Disease Control Rate (DCR)

    DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.

    Measured: 3 months

  4. Progression Free Survival (PFS)

    PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.

    Measured: 6 months

  5. Overall Survival (OS)

    OS was defined as the time from date of start of treatment to date of death due to any cause.

    Measured: 12 months

Timeline

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

  1. First posted17 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01317615
Sponsor's protocol ID
CRAD001KDE37
Other IDs
EudraCT 2010-022273-34, 2010-022273-34
Status last verified
Feb 2016
First submitted
16 Mar 2011
Last updated
30 Mar 2016

Publications

  • Christopoulos P, Engel-Riedel W, Grohe C, Kropf-Sanchen C, von Pawel J, Gutz S, Kollmeier J, Eberhardt W, Ukena D, Baum V, Nimmrich I, Sieder C, Schnabel PA, Serke M, Thomas M. Everolimus with paclitaxel and carboplatin as first-line treatment for metastatic large-cell neuroendocrine lung carcinoma: a multicenter phase II trial. Ann Oncol. 2017 Aug 1;28(8):1898-1902. doi: 10.1093/annonc/mdx268.

    PubMed 28535181

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RAD001, Paclitaxel and Carboplatin in people with Carcinoma, Large Cell and Neuroendocrine Tumors, run by Novartis Pharmaceuticals at 9 sites 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 10 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 30 Mar 2016). 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?

Percentage of Participants Progression-free (time frame: 3 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 NCT01317615, 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 30 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in