Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease (STIMULI)
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|ClinicalTrials.gov Identifier: NCT02046733|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2014
Last Update Posted : March 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer||Drug: Ipilimumab Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Open-label Phase II Trial of Consolidation With Nivolumab and Ipilimumab in Limited-stage SCLC After Chemo-radiotherapy|
|Actual Study Start Date :||July 28, 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2022|
Experimental: Nivolumab + Ipilimumab
- 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
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)
Other Name: Yervoy
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).
Other Name: Opdivo
No Intervention: Observation
no further treatment; tumour assessment, follow-up documentation and collection of biological material will be done according to the same schedule as Arm 1.
- Overall survival [ Time Frame: From date of randomisation until death from any cause, assessed up to a maximum of 6,5 years ]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 [ 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 ]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.
- Objective response [ Time Frame: From randomisation to termination of trial treatment, up to a maximum of 2 years ]
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 [ Time Frame: From date of randomisation until discontinuation of treatment for any reason, assessed up to a maximum of 6.5 years ]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.
- Toxicity [ Time Frame: Up to a maximum of 6.5 years ]Adverse events classified according to NCI CTCAE version 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046733
|Study Chair:||Solange Peters, MD PhD||European Thoracic Oncology Platform (ETOP)|
|Study Chair:||Dirk De Ruysscher, MD PhD||Maastro Clinic, Maastricht, The Netherlands|