Nivolumab and Ipilimumab Versus Chimiotherapy in First Line Treatment in PS 2 or Elderly in Advanced NSCLC Patients (eNERGY)
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|ClinicalTrials.gov Identifier: NCT03351361|
Recruitment Status : Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : June 1, 2020
Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths in Western countries. Unfortunately, at the time of diagnosis, the majority of patients already have metastatic disease and a systemic, palliative treatment is the primary therapeutic option.
Guidelines for PS 2 patients or older than 75 years old patients at the time of diagnosis recommend for fit patients a carboplatin doublet chemotherapy.
Nivolumab has proven efficacy in 3rd line squamous cell lung carcinoma and is superior to chemotherapy in 2nd line treatment of squamous and non-squamous lung cancer in term of overall survival.
In 1st line, nivolumab failed to show superiority compared to a platin based doublet in terms of progression free survival and overall survival in tumors ≥ 5% PD-L1 expression. The association Nivolumab plus Ipilimumab showed encouraging results in first line setting in phase 1 study.
The investigators think that with regard to the manageable toxicity of nivolumab in lung cancer population and the possibility to obtain long responses, this association could be a valid option for this population of elderly and/or PS2 patients in term of overall survival.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non Small Cell Lung Cancer||Drug: Nivolumab + Ipilimumab Drug: Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Study Testing Nivolumab and Ipilimumab Versus a Carboplatin Based Doublet in First Line Treatment of PS 2 or Elderly (More Than 70 Years Old) Patients With Advanced Non-small Cell Lung Cancer|
|Actual Study Start Date :||February 19, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2022|
|Experimental: Nivolumab + Ipilimumab||
Drug: Nivolumab + Ipilimumab
Nivolumab dosed intravenously over 30 minutes at 240 mg every 2 weeks combined with Ipilimumab dosed intravenously over 30 minutes at 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol.
Active Comparator: Chemotherapy
carboplatin and pemetrexed or carboplatin and paclitaxel
Doublet of chemotherapy according to standard of care carboplatin (AUC 5) with a dose that will be capped to 700 mg and pemetrexed (500 mg/m²) over 4 to 6 hours every three weeks (restricted to non-squamous histology) or carboplatin (AUC 6) with a dose that will be capped to 700 mg and paclitaxel (90 mg/m²) D1 D8 D15 over 4 to 6 hours every 4 weeks, with a maximum of 4 cycles of carboplatin based doublet, and the possibility to use maintenance with pemetrexed.
- Overall survival [ Time Frame: From date of randomization until the date of date of death from any cause, whichever came first, assessed up to 3 years maximum ]
- Survival rate [ Time Frame: 1 year ]
- Objective response rate [ Time Frame: 2 years ]according to RECIST 1.1
- Progression free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]
- Safety rate [ Time Frame: 2 years ]Incidence of Treatment-Emergent Adverse Events according to CTCAE version 4.0
- Tolerability rate [ Time Frame: 2 years ]Incidence of Treatment-Emergent Adverse Events according to CTCAE version 4.0
- Quality of life score [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]according to EQ-5D questionnaire
- Quality of life score [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years maximum ]according to EORTC QLQ-ELD14 questionnaire
- PD-L1 [ Time Frame: 2 years ]testing by immunochemistry
- Geriatric evaluation [ Time Frame: inclusion and 2 months ]according to geriatric mini data set
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): NCT03351361
|Principal Investigator:||Hervé Léna||CHU Rennes|