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

NCT ID: NCT01317615

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-03-31

Brief 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.

Conditions

Carcinoma, Large Cell; Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAD001 plus paclitaxel/carboplatin

Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.

Group Type: EXPERIMENTAL

RAD001

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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.

Interventions

RAD001

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.

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Carboplatin

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.

Intervention Type: DRUG

Other Intervention Names

Everolimus

Eligibility Criteria

Inclusion Criteria

1. Patients who give a written informed consent obtained according to local guidelines

2. Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:

1. Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent

2. Relapse must be confirmed by histology

3. Neuroendocrine differentiation

3. World Health organisation (WHO) performance status grade ≤ 1

4. measurable disease

5. Adequate bone marrow function

6. Adequate liver function

7. Adequate renal function

Exclusion Criteria

1. History or clinical evidence of central nervous system (CNS) metastases.

2. Presence of SCLC cells

3. 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)

4. 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)

5. Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy

6. 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

7. Patients who have received prior therapy with RAD001 or other mTOR inhibitors

8. Having any severe and/or uncontrolled medical conditions

9. Women who are pregnant or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bremen, , Germany

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Gauting, , Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

Hemer, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 28535181 (View on PubMed)

Other Identifiers

EudraCT 2010-022273-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

2010-022273-34

Identifier Type: -

Identifier Source: secondary_id

CRAD001KDE37

Identifier Type: -

Identifier Source: org_study_id