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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment630 people
  • Recruiting US sites17
  • SponsorAstraZeneca
  • RegistryNCT05061550

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer: a one-minute explainerNCT050615501 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 95 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

durvalumab. A monoclonal antibody directed against B7H1 (B7 homolog 1; programmed cell death ligand 1) with potential immunostimulating activity. Upon intravenous administration, durvalumab binds to the cell surface antigen B7H1, thereby blocking B7H1 signaling. This may activate the immune system to exert a cytotoxic T-lymphocyte (CTL) response against B7H1-expressing tumor cells. B7H1, a member of the B7 protein superfamily and a negative regulator of cytokine synthesis, is overexpressed on certain tumor cell types. NCI Drug Dictionary

Treatments listed in the registry

  • Durvalumab (Drug): Participants will receive Durvalumab via intravenous route.
  • Oleclumab (Drug): Participants will receive Oleclumab via intravenous route.
  • Monalizumab (Drug): Participants will receive Monalizumab via intravenous route.
  • Dato-DXd (Drug): Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
  • AZD0171 (Drug): Participants will receive AZD0171 via intravenous route.
  • Carboplatin (Drug): Carboplatin as chemotherapy
  • Cisplatin (Drug): Cisplatin as chemotherapy
  • Pemetrexed/Cisplatin (Drug): Pemetrexed/Cisplatin as chemotherapy
  • Pemetrexed/Carboplatin (Drug): Pemetrexed/Carboplatin as chemotherapy
  • Carboplatin/Paclitaxel (Drug): Carboplatin/Paclitaxel, as chemotherapy
  • Volrustomig (Drug): Participants will receive Volrustomig via intravenous route.
  • Rilvegostomig (Drug): Participants will receive Rilvegostomig via intravenous route.

The study

Treatment groups

Randomized · Parallel · masking: None

Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX) (Experimental)

Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Arm 2: Monalizumab + Durvalumab + CTX (Experimental)

Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Arm 3: Volrustomig (Dose Exploration) + CTX (Experimental)

Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Arm 4: Dato-DXd + durvalumab + single agent platinum (Experimental)

Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin

Arm 5: AZD0171 + durvalumab + CTX (Experimental)

Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Arm 6: Rilvegostomig + CTX (Experimental)

Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Arm 7: Dato-DXd + Rilvegostomig + single agent platinum (Experimental)

Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • surgery: Part of the study plan

Goals

What the study measures

Main goals

  • Number of participants with pathological complete response (pCR) (From randomization to approximately 15 weeks after the first dose of study interventions)
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Until Day 90 after the last dose of study interventions (Up to approximately 3 years))

Other goals

  • Number of participants experiencing an event-free survival (EFS) event
  • Number of participants experiencing a disease-free survival (DFS) event
  • Number of participants having surgical resection
  • Number of participants with major pathological response (mPR)
  • Number of participants with Objective response rate (ORR)
  • Overall survival (OS)
  • Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)
  • Number of participants with anti-study drug antibodies (ADA)
  • Baseline PD-L1 expression
  • Changes in circulating tumour DNA (ctDNA)

Planned enrollment: 630 (estimated).

Where

Recruiting US sites

  • Research Site, Little Rock, Arkansas
  • Research Site, Los Angeles, California
  • Research Site, New Haven, Connecticut
  • Research Site, Chicago, Illinois
  • Research Site, Baltimore, Maryland
  • Research Site, Boston, Massachusetts
  • Research Site, Omaha, Nebraska
  • Research Site, Cleveland, Ohio
  • Research Site, Pittsburgh, Pennsylvania
  • Research Site, Chattanooga, Tennessee
  • Research Site, Memphis, Tennessee
  • Research Site, Nashville, Tennessee
  • Research Site, Nashville, Tennessee
  • Research Site, Houston, Texas
  • Research Site, Fairfax, Virginia
  • Research Site, Edmonds, Washington
  • Research Site, Seattle, Washington

61 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 20, 2026. Public record; not medical advice.

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