Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-95
SponsorAstraZeneca
About this trial
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Eligibility criteria
Qualifiers
Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ and bone 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.
Disqualifiers
Participants with sensitising EGFR mutations or ALK translocations.
Participants with baseline PD-L1 expression status <1% (Arms 6 and 7 only).
Active or prior documented autoimmune or inflammatory disorders.
Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
Trial design
Treatments tested in this trial
- Durvalumab
- Oleclumab
- Monalizumab
- Dato-DXd
- AZD0171
- Carboplatin
- Cisplatin
- Pemetrexed/Cisplatin
- Pemetrexed/Carboplatin
- Carboplatin/Paclitaxel
- Volrustomig
- Rilvegostomig
Treatment groups
630 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
AstraZeneca
Lead sponsor
Parexel
Collaborator
Source ClinicalTrials.gov