NCT05061550 Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
| NCT ID | NCT05061550 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 630 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2030-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 630 participants in total. It began in 2022-04-14 with a primary completion date of 2030-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. * Adequate pulmonary function. Exclusion Criteria: * 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. * History of another primary malignancy. * Participants with small-cell lung cancer or mixed small-cell lung cancer. * History of active primary immunodeficiency. * History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * 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 at baseline, to obtain potentially curative resection of primary tumour. * QTcF (QT interval corrected by Fridericia's formula) 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 interventions. * Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded. * Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions. * Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
Contact & Investigator
Tina Cascone, MD
PRINCIPAL INVESTIGATOR
MD Anderson Cancer Center Houston, TX 77030
Frequently Asked Questions
Who can join the NCT05061550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05061550 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05061550 currently recruiting?
Yes, NCT05061550 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT05061550 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Oakland, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT05061550 clinical trial?
NCT05061550 is sponsored by AstraZeneca. The principal investigator is Tina Cascone, MD at MD Anderson Cancer Center Houston, TX 77030. The trial plans to enroll 630 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.