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

NCT05061550
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
630
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Lead sponsor
AstraZeneca
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Start date
2022-04-14
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Number of sites
97
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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.
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Acronym
NeoCOAST-2
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Short title
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
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Official title
A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2030-05-28
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First posted
2021-09-29
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Registry last updated
2026-08-21
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Primary completion date
2030-05-28
clinicaltrials.gov
Start date
2022-04-14
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Participants
630
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Participant count basis
Estimated
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Planned participants
630
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Protocol amendments
8
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Number of sites
97
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05061550
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ClinicalTrials.gov ID
NCT05061550
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with pathological complete response (pCR)

    Timeframe: From randomization to approximately 15 weeks after the first dose of study interventions

  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Timeframe: Until Day 90 after the last dose of study interventions (Up to approximately 3 years)

  1. Number of participants experiencing an event-free survival (EFS) event

    Timeframe: Up to approximately 3 years

  2. Number of participants experiencing a disease-free survival (DFS) event

    Timeframe: Up to approximately 3 years

  3. Number of participants having surgical resection

    Timeframe: From randomization to approximately 15 weeks after the first dose of study interventions

  4. Number of participants with major pathological response (mPR)

    Timeframe: From randomization to approximately 15 weeks after the first dose of study interventions

  5. Number of participants with Objective response rate (ORR)

    Timeframe: From randomization to approximately 15 weeks after the first dose of study interventions

  6. Overall survival (OS)

    Timeframe: Up to approximately 3 years

  7. Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)

    Timeframe: From randomization to last dose of study interventions (Up to approximately 3 Years)

  8. Number of participants with anti-study drug antibodies (ADA)

    Timeframe: From randomization to 3 months after last dose of study interventions (Up to approximately 3 Years)

  9. Baseline PD-L1 expression

    Timeframe: At Screening/ baseline

  10. Changes in circulating tumour DNA (ctDNA)

    Timeframe: From randomization to up to 24 months after last dose of study interventions (Up to approximately 3 Years)

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
95 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Research SiteLittle Rock, United StatesRecruiting
  • Research SiteLos Angeles, United StatesRecruiting
  • Research SiteOakland, United StatesWithdrawn
  • Research SiteNew Haven, United StatesRecruiting
  • Research SiteStuart, United StatesCompleted
  • Research SiteGainesville, United StatesCompleted
  • Research SiteChicago, United StatesRecruiting
  • Research SiteBaltimore, United StatesWithdrawn
  • Research SiteBaltimore, United StatesRecruiting
  • Research SiteBoston, United StatesRecruiting
  • Research SiteSaint Louis Park, United StatesCompleted
  • Research SiteOmaha, United StatesRecruiting
  • Research SiteBuffalo, United StatesRecruiting
  • Research SiteCleveland, United StatesRecruiting
  • Research SitePittsburgh, United StatesRecruiting
  • Research SiteChattanooga, United StatesRecruiting
  • Research SiteMemphis, United StatesRecruiting
  • Research SiteNashville, United StatesWithdrawn
  • Research SiteNashville, United StatesRecruiting
  • Research SiteNashville, United StatesRecruiting
  • Research SiteHouston, United StatesRecruiting
  • Research SiteHouston, United StatesRecruiting
  • Research SiteFairfax, United StatesRecruiting
  • Research SiteEdmonds, United StatesRecruiting
  • Research SiteSeattle, United StatesRecruiting

And 72 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-508852-21-00
  • 2021-003369-37
Sources for references
clinicaltrials.gov

Related records

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Collaborators (1)

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Conditions (2)

Targets (23)