NCT04108026: SAVIMMUNE

Immunotherapy in Patient With Poor General Condition

Completed Phase 2 Last updated 3 October 2025

What this trial tests

Phase 2 trial testing Durvalumab in Non-small Cell Lung Cancer Stage IV in 50 participants. Completed in 26 September 2025.

Timeline

14 October 2020

Primary endpoint
30 November 2023

26 September 2025

Quick facts

Lead sponsor	Intergroupe Francophone de Cancerologie Thoracique
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	14 October 2020
Primary completion	30 November 2023
Estimated completion	26 September 2025
Sites	20 locations across France

Drugs / interventions tested

• Durvalumab — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer Stage IV — all drugs for Non-small Cell Lung Cancer Stage IV →

Sponsor

Intergroupe Francophone de Cancerologie Thoracique — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-small Cell Lung Cancer Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS \>3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

Publications & conference data

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

1. Advances in molecular pathology and therapy of non-small cell lung cancer.
   Huang Q, Li Y, Huang Y, Wu J, et al · · 2025 · cited 43× · PMID 40517166 · DOI 10.1038/s41392-025-02243-6
2. First-line immunotherapy in non-small cell lung cancer patients with poor performance status: a systematic review and meta-analysis.
   Facchinetti F, Di Maio M, Perrone F, Tiseo M. · · 2021 · cited 30× · PMID 34295688 · DOI 10.21037/tlcr-21-15
3. Considerations for immunotherapy in patients with cancer and comorbid immune dysfunction.
   Florou V, Puri S, Garrido-Laguna I, Wilky BA. · · 2021 · cited 11× · PMID 34277835 · DOI 10.21037/atm-20-5207
4. Does Very Poor Performance Status Systematically Preclude Single Agent Anti-PD-1 Immunotherapy? A Multicenter Study of 35 Consecutive Patients.
   Gounant V, Duruisseaux M, Soussi G, Van Hulst S, et al · · 2021 · cited 11× · PMID 33801285 · DOI 10.3390/cancers13051040
5. Immune Checkpoint Inhibitors in "Special" NSCLC Populations: A Viable Approach?
   Bronte G, Cosi DM, Magri C, Frassoldati A, et al · · 2023 · cited 9× · PMID 37628803 · DOI 10.3390/ijms241612622
6. Durvalumab in Patients With Treatment-Naive Stage IV NSCLC With an ECOG Performance Status of 2 to 3 and High PD-L1 Tumor Expression (IFCT-1802 SAVIMMUNE): A Multicenter Phase 2 Trial.
   Gounant V, Greillier L, Mascaux C, Pinquie F, et al · · 2025 · PMID 41473840 · DOI 10.1016/j.jtocrr.2025.100908