NCT05157542

Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC

Status unknown Phase 1 Last updated 15 December 2021

What this trial tests

Phase 1 trial testing Durvalumab in Stage III Non-small Cell Lung Cancer in 9 participants. Status unknown.

Timeline

10 June 2021

Primary endpoint
10 June 2023

10 June 2023

Quick facts

Lead sponsor	Juan LI, MD
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	10 June 2021
Primary completion	10 June 2023
Estimated completion	10 June 2023
Sites	1 location across China

Drugs / interventions tested

• Durvalumab — full drug profile →
• nanoparticle albumin bound paclitaxel
• low dose radiation therapy — full drug profile →

Conditions studied

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

Sponsor

Juan LI, MD

Who can join

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

Sponsor's own description

Introduction: Although PACIFIC regimen definitive concurrent chemoradiotherapy (CRT) followed by Durvalumab consolidation therapy is considered the standard of care for most of stage III NSCLC patients, neoadjuvant immunotherapy combined with chemotherapy followed by surgery has shown the trend to be considered for some potentially resectable patients. The rationales for neoadjuvant treatment are tumor regression effect before surgery, early eradication of micrometastasis. Recently the investigators also find some clinical trials exploring the adding of 45 Gy in 25 fractions radiation to the combination of chemotherapy and immunotherapy neoadjuvant therapy and the investigators could see the safety is the most concern, especially the pneumonitis incidence. Low dose radiation could help control the toxicity induced by radiation and has synergic effect with immunotherapy. The aim of this phase Ib study is to assess the safety and feasibility of the combination of the concurrent low dose radiation, chemotherapy and Durvalumab neoadjuvant therapy, to explore which radiation dose is the best among our three-dose designs and evaluate if the combining neoadjuvant therapy could further improve MPR in the meantime no severe toxicities especially the grade 3-4 pneumonitis would happen.

Method: 9 eligible patients with histologically confirmed NSCLC (potentially resectable clinical stage III according to the American Joint Committee on Cancer 8th staging system) are enrolled. Patients receive Chemo (Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mg/m2 and carboplatin AUC 5 ) and durvalumab (Day 1 and 22, 1500mg) and radiotherapy of 10 Gy in 5 fractions, 20 Gy in 10 fractions, 30 Gy in 15 fractions respectively in our three groups from Day1, followed by surgery. After surgery, patients are suggested to be treated with durvalumab for one year (every 4weeks, 1500 mg). The primary endpoints are safety and tolerability. The secondary endpoints are objective response rate (ORR), event-free survival EFS), overall survival (OS), pathologic complete response (pCR), and major pathologic response(MPR) in the primary tumor. biomarker analysis of PD-L1 using cancer tissue and LIPI, ctDNA using blood sample will be conducted pre-and post- neoadjuvant and post-surgery.

Publications & conference data

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

1. Radiotherapy combined with immunotherapy: the dawn of cancer treatment.
   Zhang Z, Liu X, Chen D, Yu J. · · 2022 · cited 463× · PMID 35906199 · DOI 10.1038/s41392-022-01102-y
2. Developments in targeted therapy & immunotherapy-how non-small cell lung cancer management will change in the next decade: a narrative review.
   Li MSC, Mok KKS, Mok TSK. · · 2023 · cited 37× · PMID 37675321 · DOI 10.21037/atm-22-4444
3. Beyond success: unveiling the hidden potential of radiotherapy and immunotherapy in solid tumors.
   Wu Y, Yi M, Niu M, Zhou B, et al · · 2024 · cited 14× · PMID 38837878 · DOI 10.1002/cac2.12576
4. Emerging Trends in Nano-Driven Immunotherapy for Treatment of Cancer.
   Kandasamy G, Karuppasamy Y, Krishnan UM. · · 2023 · cited 11× · PMID 36851335 · DOI 10.3390/vaccines11020458
5. Progress and perspectives of perioperative immunotherapy in non-small cell lung cancer.
   Peng Y, Li Z, Fu Y, Pan Y, et al · · 2023 · cited 11× · PMID 36761954 · DOI 10.3389/fonc.2023.1011810
6. Combating cancer immunotherapy resistance: a nano-medicine perspective.
   Kong X, Xie X, Wu J, Wang X, et al · · 2025 · cited 5× · PMID 40207650 · DOI 10.1002/cac2.70025
7. Role of Neoadjuvant Immune Checkpoint Inhibitors in Resectable Non-Small Cell Lung Cancer.
   Riano I, Abuali I, Sharma A, Durant J, et al · · 2023 · cited 4× · PMID 37259381 · DOI 10.3390/ph16020233
8. Nanotherapeutics Plus Immunotherapy in Oncology: Who Brings What to the Table?
   Timon-David E, Perez C, Rodallec A. · · 2022 · cited 2× · PMID 36365144 · DOI 10.3390/pharmaceutics14112326