Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-02-19
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to assess the safety and efficacy of neoadjuvant Durvalumab in combination with chemotherapy and Oleclumab or Monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel
• Treatments: Durvalumab

Criteria

Inclusion Criteria:

• Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIA).

• WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Adequate organ and marrow function.

• Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.

• Participants will be suitable for inclusion if the planned surgery to be performed will be lobectomy, sleeve resection, or bilobectomy.

• A pre- or post-bronchodilator forced expiratory volume in 1 (FEV1) of 1.0 L and diffusing capacity of the lungs for carbon monoxide (DLCO) > 40% postoperative predicted value.

Exclusion Criteria:

• Participants with sensitising EGFR mutations or ALK translocations.

• History of allogeneic organ transplantation.

• Active or prior documented autoimmune or inflammatory disorders.

• Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.

• History of another primary malignancy.

• Participants with small-cell lung cancer or mixed small-cell lung cancer.

• History of active primary immunodeficiency.

• Participants who have preoperative radiotherapy treatment as part of their care plan.

• Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon, to obtain potentially curative resection of primary tumour.

• QTc (QT interval corrected) interval ≥ 470 ms.

• Any medical contraindication to treatment with chemotherapy as listed in the local labelling.

• Participants with moderate or severe cardiovascular disease:

• Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.

• Receipt of live attenuated vaccine within 30 days prior to the first dose of study drugs.

• Prior exposure to immune-mediated therapy. Participants who received agents targeting the adenosine pathway and anti-NKG2A agents are also excluded.

• Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs.