NCT03083691

BIOLUMA: Biomarkers for Nivolumab and Ipilimumab and Evaluation of the Combination in Lung Cancer

Completed Phase 2 Last updated 17 January 2024

What this trial tests

Phase 2 trial testing Nivolumab, Ipilimumab in Carcinoma, Non-Small-Cell Lung in 90 participants. Completed in 20 November 2023.

Timeline

13 April 2017

Primary endpoint
31 August 2022

20 November 2023

Quick facts

Lead sponsor	Lung Cancer Group Cologne
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	13 April 2017
Primary completion	31 August 2022
Estimated completion	20 November 2023
Sites	16 locations across Germany

Drugs / interventions tested

• Nivolumab, Ipilimumab
• Nivolumab, Ipilimumab

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
• Carcinoma, Small Cell Lung — all drugs for Carcinoma, Small Cell Lung →

Sponsor

Lung Cancer Group Cologne

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Carcinoma, Small Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BIOLUMA is a multicentric non-randomised phase II trial in patients with non-squamous non-small cell lung cancer (NSCLC) (Cohort 1) and patients with small-cell lung cancer (SCLC) (Cohort 2) after failure of platinum-based first-line therapy. NSCLC patients are treated with nivolumab until disease progression and subsequently receive a combination therapy of nivolumab and ipilimumab. SCLC patients receive four cycles of nivolumab in combination with ipilimumab and subsequent nivolumab monotherapy. Primary endpoint for both cohorts is overall response rate of combination therapy.

Within the diagnostic part tumor biopsies will be analysed. Tumor tissue will be obtained before initiation of therapy and after progression on nivolumab monotherapy before addition of ipilimumab in Cohort 1 and after completion of the four nivolumab/ipilimumab combination cycles before continuation of nivolumab monotherapy in Cohort 2, respectively. Flow cytometry of blood samples and microbiome analysis of deep rectal swaps are performed prior to therapy as well as during course of treatment.

Cohort 1 (NSCLC) is closed for enrollment due to Sponsor decision.

In Cohort 2 (SCLC) a prescreening for high Tumor Mutation Burden is necessary before enrollment.

Publications & conference data

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

1. 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
2. Clinical development of targeted and immune based anti-cancer therapies.
   Seebacher NA, Stacy AE, Porter GM, Merlot AM. · · 2019 · cited 147× · PMID 30975211 · DOI 10.1186/s13046-019-1094-2
3. Evolutionary trajectories of small cell lung cancer under therapy.
   George J, Maas L, Abedpour N, Cartolano M, et al · · 2024 · cited 82× · PMID 38480884 · DOI 10.1038/s41586-024-07177-7
4. Potential immune escape mechanisms underlying the distinct clinical outcome of immune checkpoint blockades in small cell lung cancer.
   Tian Y, Zhai X, Han A, Zhu H, et al · · 2019 · cited 76× · PMID 31253167 · DOI 10.1186/s13045-019-0753-2
5. Immunotherapy in small-cell lung cancer: from molecular promises to clinical challenges.
   Pavan A, Attili I, Pasello G, Guarneri V, et al · · 2019 · cited 74× · PMID 31383005 · DOI 10.1186/s40425-019-0690-1
6. 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
7. 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
8. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255