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Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (STIMULI)

Primary Purpose

Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ipilimumab

Nivolumab

About this trial

This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer focused on measuring SCLC, CTLA-4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for enrolment:

Histologically or cytologically confirmed small cell lung carcinoma
Untreated limited stage disease ((with the exception of one cycle of chemotherapy given prior to enrolment) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for SCLC proposal). M0 proven by
Whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan; AND
brain MRI (or contrast enhanced CT of the brain). . within 28 days before start of chemotherapy.
Age ≥ 18 years
ECOG performance status 0-1
Adequate haematological function:
haemoglobin > 9 g/dL
neutrophils count >1.5×109/L
platelet count > 100 × 109/L
Adequate liver function:
Total bilirubin < 2.5 × ULN
ALT and/or AST < 2.5 × ULN
alkaline phosphatase < 5 ULN.
Adequate renal function: Calculated creatinine clearance ≥ 30 mL/min (Cockroft-Gault)
Pulmonary function FEV1 of 1.0L or > 40% predicted value and DLCO > 40% predicted value.
Patient capable of proper therapeutic compliance, and accessible for correct follow-up.
Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning of chemotherapy.
All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment.
Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for
1. Chemo-radiotherapy treatment and PCI, and subsequent randomisation, including mandatory biological samples
2. Optional biological material collection, long-term storage and future use of biological material for translational research

Inclusion Criteria for randomisation:

Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, ≥85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI
non-PD after chemo-radiotherapy and PCI
ECOG performance status 0-2
Recovery of all adverse events to a grade ≤1, except for fatigue, appetite, oesophagitis and renal impairment (where ≤2 is allowed) and alopecia (any grade)
Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomisation.

Exclusion Criteria for enrolment:

Patient with mixed small-cell and non-small-cell histologic features
Patient with pleural or pericardial effusions proven to be malignant
Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast (if no RT was involved).
Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the study.
Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy.
Known or suspected hypersensitivity to nivolumab or ipilimumab or any of their excipients.
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (e.g. steroids) treatment, such as but not limited to ulcerative colitis and Crohn´s disease, rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis).
Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment.
Interstitial lung disease or pulmonary fibrosis
Women who are pregnant or in the period of lactation.
Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
Patients with any concurrent anticancer systemic therapy (except for chemotherapy cycle 1).
HIV, active Hepatitis B or Hepatitis C infection
Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer
Planned radiotherapy to lung of mean dose > 20 Gy or V20 > 35 %
Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study.
Prior chemotherapy or radiotherapy for SCLC. Exception: one cycle of chemotherapy (as specified to section 10.2) may be administered prior to enrolment.

Exclusion criteria for randomisation:

Less than 4 cycles of chemotherapy administered, less than 85% PTV of thoracic radiotherapy delivered, or PCI not completed
Progressive disease after chemo-radiotherapy and PCI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nivolumab + Ipilimumab

Observation

Arm Description

- Induction: Nivolumab at a dose of 1 mg/kg i.v. followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. once every 3 weeks, 4 cycles - Maintenance: Nivolumab 240 mg i.v. once every 2 weeks, for a maximum of 12 months from start of maintenance

no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as Arm 1.

Outcomes

Primary Outcome Measures

Overall survival

Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.

Progression-free survival determined by RECIST 1.1

Defined as time from the date of randomisation until documented progression or death, if progression is not documented. Censoring will occur at the last tumor assessment only if patient is lost to follow-up.

Secondary Outcome Measures

Objective response

Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from randomisation to termination of trial treatment. Objective response to chemo-radiotherapy will be determined by tumour assessment around week 15. Objective response to trial treatment will be determined using RECIST 1.1 criteria

Time to treatment failure

Defined as time from the date of randomisation to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death). Censoring will occur at the last follow-up date.

Adverse events

Toxicity of study treatment is assessed by adverse events classified according to NCI CTCAE version 4.

Full Information

NCT ID

NCT02046733

First Posted

January 17, 2014

Last Updated

February 5, 2021

Sponsor

ETOP IBCSG Partners Foundation

Collaborators

Intergroupe Francophone de Cancerologie Thoracique, Ludwig Center for Cancer Research of Lausanne, Frontier Science Foundation, Hellas, Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02046733

Brief Title

Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease

Acronym

STIMULI

Official Title

A Randomised Open-label Phase II Trial of Consolidation With Nivolumab and Ipilimumab in Limited-stage SCLC After Chemo-radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 28, 2014 (Actual)

Primary Completion Date

May 2020 (Actual)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ETOP IBCSG Partners Foundation

Collaborators

Intergroupe Francophone de Cancerologie Thoracique, Ludwig Center for Cancer Research of Lausanne, Frontier Science Foundation, Hellas, Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.

Detailed Description

At the time of diagnosis, 30% of patients with small cell lung carcinoma (SCLC) will have limited stage disease, now called stage I-IIIB (IASLC). The outcome of limited disease SCLC is still poor, with a median survival of 16 to 24 months with current forms of treatment and only 15-25% long term survivors. Combining chemotherapy and thoracic radiotherapy is the standard treatment approach in limited-stage SCLC with a combination of platinum compounds (cis- or carboplatin) and etoposide and cisplatin (PE) as the backbone regimen. Concurrent chemo-radiotherapy is superior to sequential treatment and early thoracic irradiation starting with first or second cycle of chemotherapy appears beneficial. Hyperfractionated accelerated radiotherapy has been shown to be more efficacious than radiotherapy given in a long overall treatment time. However, availability and routine-use of hyperfractionated radiotherapy remains a matter of debate. Therefore, in this trial, both radiotherapy schedules of accelerated twice-daily administration or once-daily radiotherapy are accepted. The choice of schedule is a stratification factor for randomisation. The adaptive immune response is triggered via effector T-cells, antigen-presenting cells (APCs) and co-stimulatory signals mediated by T cell receptors such as CD28. The interplay of these signals results in the activation and clonal proliferation of T cells. T-cell proliferation is tightly regulated in order to avoid autoimmunity. The balance between co-stimulatory signals mediated by CD28 and co-inhibitory signals via so called immune checkpoint receptors is crucial for the maintenance of self-tolerance and to protect tissues from damage during normal immune response. After activation, T-cells express the immune checkpoint receptors cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death protein 1 (PD-1). CTLA-4- and PD-1 expressing T-cells play a critical role in maintaining self-tolerance but are also responsible for non-responsiveness to tumour antigens. Cancer cells escape from im-mune surveillance by expressing immune checkpoint receptors. The goal of immune check-point inhibitor therapies is not to activate the immune system to attack particular targets on tumour cells, but rather to remove inhibitory pathways that block effective antitumour T cell responses. Ipilimumab is a monoclonal antibody that binds to CTLA-4 and inhibits the interactions with the ligands B7.1 and B7.2, Nivolumab is a monoclonal antibody that targets PD-1. Engagement of PD-1 by its natural ligands, PD-L1 and PD-L2, results in an inhibition of T cell proliferation, survival and cyto-kine secretion. Nivolumab abrogates this interaction between PD-1 and its ligands. The two antibodies, nivolumab and ipilimumab, do not only target different immune cell receptors, they also regulate distinct inhibitory pathways and have therefore non-overlapping mechanisms of action. Anti-CTLA-4 therapies seem to drive T-cells into tumours, resulting in an increased number of intratumour T-cells and a concomitant increase in IFN-y. This in turn can induce the expression of PD-L1 in the tumour microenvironment, with subsequent inhibition of antitumour T-cell responses, but may also increase the chance of benefit from anti-PD-1 and anti-PD-L1 therapies. A combination treatment with anti-CTLA-4 (e.g. ipili-mumab) plus anti PD-1 (e.g. nivolumab) or anti-PD-L1 antibodies should enable the creation of an immunogenic tumour microenvironment with subsequent clinical benefit for patients. Nivolumab monotherapy has been approved for the treatment of advanced melanoma (FDA, EMA, and Japan) and previously treated squamous NSCLC (FDA, positive CHMP opin-ion). Nivolumab and ipilimumab improved PFS compared to nivolumab or ipilimumab alone in a study in melanoma (CA209067). In a randomised open-label phase I/II trial (CheckMate 032), evaluating nivolumab with or without ipilimumab in pretreated SCLC patients with progressive disease and sensitive or refractory to platinum based chemotherapy, based on an interim analysis a response rate of 33% and disease stabilisation in 22% was observed for the combination of nivolumab and ipilimumab compared to 18% response rate and 20% stable disease with nivolumab mono-therapy. Both, nivolumab monotherapy and nivolumab plus ipilimumab combination treatment were tolerable for the treatment of SCLC, and no new safety profile was identified compared to the profile of nivolumab with or without ipilimumab in other anti-cancer therapies. Nivolumab plus ipilimumab will be administered as a consolidation treatment after comple-tion of a standard treatment including chemo-radiotherapy and prophylactic cranial irradia-tion (PCI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer

Keywords

SCLC, CTLA-4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab + Ipilimumab

Arm Type

Experimental

Arm Description

Arm Title

Observation

Arm Type

No Intervention

Arm Description

no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as Arm 1.

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy

Intervention Description

Induction phase: i.v. 3 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation)

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

Induction phase: Nivolumab i.v. 1 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation) Maintenance Phase: Nivolumab 240 mg i.v once every 2 weeks for a maximum of 12 months from start of maintenance (the first dose of maintenance nivolumab will be administered 3 weeks after the last IMP doses of induction Phase).

Primary Outcome Measure Information:

Title

Overall survival

Description

Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.

Time Frame

From date of randomisation until death from any cause, assessed up to a maximum of 6,5 years

Title

Progression-free survival determined by RECIST 1.1

Description

Time Frame

From date of randomisation until documented progression or death, if progression is not documented, assessed up to a maximum of 6,5 years

Secondary Outcome Measure Information:

Title

Objective response

Description

Time Frame

From randomisation to termination of trial treatment, up to a maximum of 2 years

Title

Time to treatment failure

Description

Time Frame

From date of randomisation until discontinuation of treatment for any reason, assessed up to a maximum of 6.5 years

Title

Adverse events

Description

Toxicity of study treatment is assessed by adverse events classified according to NCI CTCAE version 4.

Time Frame

Up to a maximum of 6.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for enrolment: Histologically or cytologically confirmed small cell lung carcinoma Untreated limited stage disease ((with the exception of one cycle of chemotherapy given prior to enrolment) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for SCLC proposal). M0 proven by Whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan; AND brain MRI (or contrast enhanced CT of the brain). . within 28 days before start of chemotherapy. Age ≥ 18 years ECOG performance status 0-1 Adequate haematological function: haemoglobin > 9 g/dL neutrophils count >1.5×109/L platelet count > 100 × 109/L Adequate liver function: Total bilirubin < 2.5 × ULN ALT and/or AST < 2.5 × ULN alkaline phosphatase < 5 ULN. Adequate renal function: Calculated creatinine clearance ≥ 30 mL/min (Cockroft-Gault) Pulmonary function FEV1 of 1.0L or > 40% predicted value and DLCO > 40% predicted value. Patient capable of proper therapeutic compliance, and accessible for correct follow-up. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning of chemotherapy. All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs. Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment. Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for Chemo-radiotherapy treatment and PCI, and subsequent randomisation, including mandatory biological samples Optional biological material collection, long-term storage and future use of biological material for translational research Inclusion Criteria for randomisation: Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, ≥85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI non-PD after chemo-radiotherapy and PCI ECOG performance status 0-2 Recovery of all adverse events to a grade ≤1, except for fatigue, appetite, oesophagitis and renal impairment (where ≤2 is allowed) and alopecia (any grade) Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomisation. Exclusion Criteria for enrolment: Patient with mixed small-cell and non-small-cell histologic features Patient with pleural or pericardial effusions proven to be malignant Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast (if no RT was involved). Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the study. Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy. Known or suspected hypersensitivity to nivolumab or ipilimumab or any of their excipients. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (e.g. steroids) treatment, such as but not limited to ulcerative colitis and Crohn´s disease, rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis). Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment. Interstitial lung disease or pulmonary fibrosis Women who are pregnant or in the period of lactation. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study. Patients with any concurrent anticancer systemic therapy (except for chemotherapy cycle 1). HIV, active Hepatitis B or Hepatitis C infection Previous radiotherapy to the thorax (prior to inclusion), including RT for breast cancer Planned radiotherapy to lung of mean dose > 20 Gy or V20 > 35 % Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study. Prior chemotherapy or radiotherapy for SCLC. Exception: one cycle of chemotherapy (as specified to section 10.2) may be administered prior to enrolment. Exclusion criteria for randomisation: Less than 4 cycles of chemotherapy administered, less than 85% PTV of thoracic radiotherapy delivered, or PCI not completed Progressive disease after chemo-radiotherapy and PCI

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Solange Peters, MD PhD

Organizational Affiliation

European Thoracic Oncology Platform (ETOP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dirk De Ruysscher, MD PhD

Organizational Affiliation

Maastro Clinic, Maastricht, The Netherlands

Official's Role

Study Chair

Facility Information:

Facility Name

Bendigo Hospital

City

Bendigo

Country

Australia

Facility Name

Coffs Harbour Health Campus

City

Coffs Harbour

Country

Australia

Facility Name

Royal Brisbane and Women's Hospital (QLD)

City

Herston

Country

Australia

Facility Name

Royal Hobart Hospital

City

Hobart

Country

Australia

Facility Name

NNSWLHD - The Tweed Hospital

City

Lismore

Country

Australia

Facility Name

Austin Hospital

City

Melbourne

Country

Australia

Facility Name

Riverina Cancer Centre

City

Mount Kuring-gai

Country

Australia

Facility Name

Port Macquarie Base Hospital

City

Port Macquarie

Country

Australia

Facility Name

Epworth HealthCare - Richmond

City

Richmond

Country

Australia

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

Country

Australia

Facility Name

University Hospital Gasthuisberg, KU Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Avignon - Institut Sainte-Catherine

City

Avignon

Country

France

Facility Name

Caen - Centre François Baclesse

City

Caen

Country

France

Facility Name

CHU

City

Caen

Country

France

Facility Name

Percy/Armées

City

Clamart

Country

France

Facility Name

Clermont-Ferrand

City

Clermont-Ferrand

Country

France

Facility Name

Créteil - CHI

City

Creteil

Country

France

Facility Name

CHU

City

Grenoble

Country

France

Facility Name

Centre Hospitalier Général

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Hôpital Louis Pradel

City

Lyon

Country

France

Facility Name

Lyon - Sud

City

Lyon

Country

France

Facility Name

AP-HM

City

Marseille

Country

France

Facility Name

Centre Hospitalier Universitaire de Montpellier

City

Montpellier

Country

France

Facility Name

City

Mulhouse

Country

France

Facility Name

CRLCC

City

Nantes

Country

France

Facility Name

Nice - CRLCC

City

Nice

Country

France

Facility Name

Orléans - CH

City

Orléans

Country

France

Facility Name

Paris - Bichat

City

Paris

Country

France

Facility Name

Paris - Saint-Louis

City

Paris

Country

France

Facility Name

Paris - Tenon

City

Paris

Country

France

Facility Name

CHU

City

Rennes

Country

France

Facility Name

Nouvel Hôpital Civil

City

Strasbourg

Country

France

Facility Name

Suresnes

City

Suresnes

Country

France

Facility Name

CHI

City

Toulon

Country

France

Facility Name

CHU

City

Toulouse

Country

France

Facility Name

CHU

City

Tours

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

Country

France

Facility Name

Klinikum Esslingen

City

Esslingen

Country

Germany

Facility Name

LungenClinic Grosshansdorf GmbH

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Klinikum München-Bogenhausen

City

München

Country

Germany

Facility Name

Thoracic Oncology Centre Munich

City

München

Country

Germany

Facility Name

Pius-Hospital Oldenburg

City

Oldenburg

Country

Germany

Facility Name

Krankenhaus der Barmherzigen Brüder

City

Trier

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

Country

Germany

Facility Name

VUMC

City

Amsterdam

Country

Netherlands

Facility Name

Maastro Clinic

City

Maastricht

Country

Netherlands

Facility Name

Hospital General Universitario Alicante

City

Alicante

Country

Spain

Facility Name

Hospital Universitario Cruces

City

Barakaldo

Country

Spain

Facility Name

Hospital De La Santa Creu I Sant Pau

City

Barcelona

Country

Spain

Facility Name

Clinico San Carlos

City

Madrid

Country

Spain

Facility Name

Hospital Puerta de Hierro

City

Madrid

Country

Spain

Facility Name

Hospital Universitario 12 Octubre

City

Madrid

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Díaz

City

Madrid

Country

Spain

Facility Name

Hospital Universitario Central De Asturias

City

Oviedo

Country

Spain

Facility Name

Hospital Virgen De La Salud

City

Toledo

Country

Spain

Facility Name

Hospital Clínico Universitario De Valencia

City

Valencia

Country

Spain

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

Country

Switzerland

Facility Name

University Hospital Zürich

City

Zürich

Country

Switzerland

Facility Name

St James' University Hospital

City

Leeds

Country

United Kingdom

Facility Name

Royal Marsden

City

London

Country

United Kingdom

Facility Name

The Christie NHS Foundation Trust

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22547592

Citation

Lynch TJ, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Neal J, Lu H, Cuillerot JM, Reck M. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study. J Clin Oncol. 2012 Jun 10;30(17):2046-54. doi: 10.1200/JCO.2011.38.4032. Epub 2012 Apr 30. Erratum In: J Clin Oncol. 2012 Oct 10;30(29):3654.

Results Reference

background

PubMed Identifier

22858559

Citation

Reck M, Bondarenko I, Luft A, Serwatowski P, Barlesi F, Chacko R, Sebastian M, Lu H, Cuillerot JM, Lynch TJ. Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial. Ann Oncol. 2013 Jan;24(1):75-83. doi: 10.1093/annonc/mds213. Epub 2012 Aug 2.

Results Reference

background

PubMed Identifier

22456429

Citation

Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol. 2012 May;13(5):459-65. doi: 10.1016/S1470-2045(12)70090-6. Epub 2012 Mar 27.

Results Reference

background

Links:

URL

http://www.etop-eu.org/

Description

Sponsor

Learn more about this trial

Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease

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Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (STIMULI)

Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial