Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03351361

Nivolumab and Ipilimumab Versus Chimiotherapy in First Line Treatment in PS 2 or Elderly in Advanced NSCLC Patients — eNERGY  

Advanced Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03351361
Study type Interventional
Source Rennes University Hospital
Contact
Status Completed
Phase Phase 3
Start date February 19, 2018
Completion date July 31, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03326752 - Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC Phase 1
Completed NCT02157883 - Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) Phase 1
Completed NCT00072631 - Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer Phase 2
Completed NCT02163733 - Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06107374 - Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG Phase 2
Completed NCT01802632 - AZD9291 First Time In Patients Ascending Dose Study Phase 1/Phase 2
Recruiting NCT06406166 - Lifei Xiaoji Wan in Treatment of Advanced NSCLC N/A
Terminated NCT04785365 - Long-Term Follow-Up Study of Patients Receiving ATL001 Phase 2
Recruiting NCT04032847 - ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC Phase 1/Phase 2
Completed NCT01631136 - Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer Phase 3
Recruiting NCT04239443 - Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue Sarcoma, and Uterine Cancer Phase 2
Completed NCT03452150 - D-0316 First Time in Patients Ascending Dose Study Phase 1
Completed NCT04144608 - Toripalimab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer Phase 2
Not yet recruiting NCT04755738 - Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer Phase 2
Completed NCT03652857 - Apatinib Combined With Vinorelbine for Non-driver Gene Mutation Non-small Cell Lung Cancer Phase 2
Completed NCT02407327 - Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling
Active, not recruiting NCT02143466 - AZD9291 in Combination With Ascending Doses of Novel Therapeutics Phase 1
Recruiting NCT05004974 - Sintilimab With Pemigatinib in Patients With PD-L1-positive and FGFR Mutated Advanced Non-small Cell Lung Cancer Phase 2
Recruiting NCT05777603 - Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT04886401 - Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With NSCLC