NCT03091491

Study of Nivolumab Verses Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer

Terminated Phase 2 Last updated 14 June 2022

What this trial tests

Phase 2 trial testing Ipilimumab in Non-Small Cell Lung Cancer in 31 participants. Terminated before completion.

Timeline

7 April 2017

Primary endpoint
18 November 2019

18 November 2019

Quick facts

Lead sponsor	National Cancer Centre, Singapore
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	7 April 2017
Primary completion	18 November 2019
Estimated completion	18 November 2019
Sites	3 locations across Singapore

Drugs / interventions tested

• Ipilimumab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

National Cancer Centre, Singapore

Who can join

Adults 21 to 99, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine whether Nivolumab in combination with Ipilimumab is associated with superior response rate compared to Nivolumab alone in patients with advanced Epidermal Growth Factor Receptor (EGFR) mutation positive Non-small Cell Lung Cancer who have failed one line of standard EGFR tyrosine kinase inhibitor and not more than one line of chemotherapy regimen. This study also aims to determine predictive biomarkers of response/benefit in patients with EGFR mutation positive NSCLC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic.
   Chan TA, Yarchoan M, Jaffee E, Swanton C, et al · · 2019 · cited 2009× · PMID 30395155 · DOI 10.1093/annonc/mdy495
2. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
3. Combination of Ipilimumab and Nivolumab in Cancers: From Clinical Practice to Ongoing Clinical Trials.
   Kooshkaki O, Derakhshani A, Hosseinkhani N, Torabi M, et al · · 2020 · cited 95× · PMID 32580338 · DOI 10.3390/ijms21124427
4. Current Clinical Progress of PD-1/PD-L1 Immunotherapy and Potential Combination Treatment in Non-Small Cell Lung Cancer.
   Li JX, Huang JM, Jiang ZB, Li RZ, et al · · 2019 · cited 45× · PMID 31838881 · DOI 10.1177/1534735419890020
5. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
   Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
6. Predictive value of PD-L1 expression in response to immune checkpoint inhibitors for esophageal cancer treatment: A systematic review and meta-analysis.
   Noori M, Yousefi AM, Zali MR, Bashash D. · · 2022 · cited 19× · PMID 36591463 · DOI 10.3389/fonc.2022.1021859
7. A Randomized Phase 2 Trial of Nivolumab Versus Nivolumab-Ipilimumab Combination in EGFR-Mutant NSCLC.
   Lai GGY, Yeo JC, Jain A, Zhou S, et al · · 2022 · cited 17× · PMID 36426287 · DOI 10.1016/j.jtocrr.2022.100416
8. Efficacy of immune checkpoint inhibitors in EGFR-Mutant NSCLC patients with EGFR-TKI resistance: A systematic review and meta-analysis.
   Qian X, Guo X, Li T, Hu W, et al · · 2022 · cited 17× · PMID 36071838 · DOI 10.3389/fphar.2022.926890