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Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab

ConditionNon-small Cell Lung Cancer Stage III
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIdris Bahce

About this trial

Lung cancer presents a significant treatment challenge, particularly in the heterogeneous stage III NSCLC patient population. While chemotherapy combined with high-dose radiotherapy (60 Gy in 30 fractions of 2 Gy once daily) is currently the recommended approach for unresectable stage III cases, it is associated with significant rates of locoregional and distant failures. Notably, the introduction of durvalumab consolidation therapy after chemoradiotherapy (CRT), as demonstrated in the PACIFIC study, has shown improved overall survival, primarily attributed to enhanced distant control. This improvement prompts further interest in investigating whether further improvements in locoregional control can lead to improved survival for patients. The present study aims to evaluate the feasibility of post-CRT surgery in patients with initially considered unresectable stage III (non-N3) NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of concurrent chemoradiotherapy (CRT).

In case of suspected N2-disease, mediastinal invasive staging (EUS, EBUS and/or mediastinoscopy) to prove N2 involvement before start of concurrent CRT is preferred.

Initial MDT recommendation for a non-surgical treatment comprising concurrent CRT (platinum-doublet, 60 Gy in 30 fractions of 2 Gy once daily) followed by durvalumab

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.

Disqualifiers

Patients with TxN3 or M1 disease

Patients with known actionable genomic alterations.

The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy)

Patients deemed inoperable based on cardiopulmonary function tests or comorbidity

Trial design

Design model

Single group

Treatments tested in this trial

  • Consolidation durvalumab

    Drug

    Patients with initially unresectable stage III NSCLC will undergo surgery after chemoradiotherapy completion when the tumor is deemed resectable by the thoracic oncology tumor board and will then receive durvalumab

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Chemoradiotherapy plus surgery and immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The rates of severe surgical morbidity and mortality

Grades 3-5 according to the Clavien-Dindo classifications for surgical complications

Time frame
Within 90-days of surgery
2

Percentage of patients with high-grade treatment-related adverse events

Grades 3-5 according to NCI CTCAE version 5.0

Time frame
Within 90-days of surgery
3

Proportion of patients proceeding to durvalumab consolidation after surgery

Number of patients starting durvalumab

Time frame
Within 2 months

Secondary outcomes

1

R0 rate

Rate of complete surgical resection (R0)

Time frame
At surgery
2

DFS at 2 years

Disease-free survival at two years after surgery

Time frame
Two years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Idris Bahce

Lead sponsor

Amsterdam UMC, location VUmc

Sponsor institution

Source ClinicalTrials.gov
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