NCT04348292

Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer

Terminated Phase 1 Results posted Last updated 22 August 2024

What this trial tests

Phase 1 trial testing Durvalumab in Lung Non-Small Cell Carcinoma in 3 participants. Terminated before completion.

Timeline

22 January 2021

Primary endpoint
4 November 2022

4 November 2022

Quick facts

Lead sponsor	Emory University
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	22 January 2021
Primary completion	4 November 2022
Estimated completion	4 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Sirolimus (sirolimus) — full drug profile →

Conditions studied

• Lung Non-Small Cell Carcinoma — all drugs for Lung Non-Small Cell Carcinoma →
• Stage I Lung Cancer AJCC v8 — all drugs for Stage I Lung Cancer AJCC v8 →
• Stage IA1 Lung Cancer AJCC v8 — all drugs for Stage IA1 Lung Cancer AJCC v8 →
• Stage IA2 Lung Cancer AJCC v8 — all drugs for Stage IA2 Lung Cancer AJCC v8 →

Sponsor

Emory University

Who can join

18 and older, any sex, with Lung Non-Small Cell Carcinoma or Stage I Lung Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 Primary · at time of surgery

Other adverse events will be listed and summarized by severity, seriousness, and by system organ class. The number and percentage of subjects who experience AEs will be presented in tabular and/or graphical format and summarized descriptively, where appropriate. The frequency of overall toxicity, categorized by toxicity grades 1 through 5, will be described.

Group	Value	95% CI
Treatment (Sirolimus, Durvalumab)	3

Complete Pathologic Response Primary · at time of surgery

Disappearance of all invasive cancer

Group	Value	95% CI
Treatment (Sirolimus, Durvalumab)	1
Treatment (Sirolimus, Durvalumab)	1

Number of Participants With Dose Limiting Toxicity (DLT) Secondary · at time of surgery

Any number of patients who experienced dose limiting toxicity

Group	Value	95% CI
Treatment (Sirolimus, Durvalumab)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: adverse event data were collected from screening until surgical resection, an average of 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Sirolimus, Durvalumab)

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (4 terms — click to expand)

Reaction	System	Treatment (Sirolimus, Durv…
dyspnea	Respiratory, thoracic and mediastinal disorders	—
fatigue	General disorders	—
chyle leak	Blood and lymphatic system disorders	—
pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT04348292 adverse events section.

Sponsor's own description

This trial studies the side effects of sirolimus and durvalumab and to see how well they work in treating patients with stage I-IIIA non-small cell lung cancer. Sirolimus is an oral medication that blocks the mTOR cellular pathway which may help the immune system work better. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sirolimus before durvalumab may help the immune system get rid of cancer.

Publications & conference data

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

1. An expanded universe of cancer targets.
   Hahn WC, Bader JS, Braun TP, Califano A, et al · · 2021 · cited 160× · PMID 33667368 · DOI 10.1016/j.cell.2021.02.020
2. Clinical implications of the interaction between PD-1/PD-L1 and PI3K/AKT/mTOR pathway in progression and treatment of non-small cell lung cancer.
   Quan Z, Yang Y, Zheng H, Zhan Y, et al · · 2022 · cited 81× · PMID 36313041 · DOI 10.7150/jca.77619
3. Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
   Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676
4. Autophagy Modulators in Cancer Therapy.
   Buzun K, Gornowicz A, Lesyk R, Bielawski K, et al · · 2021 · cited 50× · PMID 34071600 · DOI 10.3390/ijms22115804
5. Combining mTOR Inhibitors and T Cell-Based Immunotherapies in Cancer Treatment.
   El Hage A, Dormond O. · · 2021 · cited 42× · PMID 33802831 · DOI 10.3390/cancers13061359
6. The Mechanisms of PD-L1 Regulation in Non-Small-Cell Lung Cancer (NSCLC): Which Are the Involved Players?
   Lamberti G, Sisi M, Andrini E, Palladini A, et al · · 2020 · cited 38× · PMID 33114576 · DOI 10.3390/cancers12113129
7. The role of metabolic ecosystem in cancer progression - metabolic plasticity and mTOR hyperactivity in tumor tissues.
   Sebestyén A, Dankó T, Sztankovics D, Moldvai D, et al · · 2021 · cited 35× · PMID 35029792 · DOI 10.1007/s10555-021-10006-2
8. Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
   Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7