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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by AstraZeneca
Sponsor
AstraZeneca
Information Provided by (Responsible Party)
AstraZeneca
Clinicaltrials.gov Identifier
NCT05061550
Other Study ID Numbers:
D9077C00001
First Submitted
September 19, 2021
First Posted
September 28, 2021
Last Update Posted
March 10, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.

Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.

Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.

Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.

Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.

Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.

Arm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.

Arm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.

Condition or DiseaseIntervention/Treatment
Non-small Cell Lung Cancer
Drug: DurvalumabDrug: DurvalumabDrug: Pemetrexed/CisplatinDrug: DurvalumabDrug: DurvalumabDrug: Pemetrexed/CisplatinDrug: Dato-DXd

Study Design

Study TypeInterventional
Actual Enrollment630 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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)
Study Start DateApril 13, 2022
Actual Primary Completion Date4yrs 1w from now
Actual Study Completion Date4yrs 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
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
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Arm 2: Monalizumab + Durvalumab + CTX
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
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Arm 3: Volrustomig (Dose Exploration) + CTX
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
Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Arm 4: Dato-DXd + durvalumab + single agent platinum
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
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Arm 5: AZD0171 + durvalumab + CTX
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
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Arm 6: Rilvegostomig + CTX
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
Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy
Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
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
Drug: Dato-DXd
Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.

Outcome Measures

Primary Outcome Measures
  1. Number of participants with pathological complete response (pCR)
  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
  1. Number of participants experiencing an event-free survival (EFS) event
  2. Number of participants experiencing a disease-free survival (DFS) event
  3. Number of participants having surgical resection
  4. Number of participants with major pathological response (mPR)
  5. Number of participants with Objective response rate (ORR)
  6. Overall survival (OS)
  7. Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)
  8. Number of participants with anti-study drug antibodies (ADA)
  9. Baseline PD-L1 expression
  10. Changes in circulating tumour DNA (ctDNA)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAstraZeneca
Locations
Research Site | Little Rock Arkansas, United States, 72205Research Site | Los Angeles California, United States, 90095Research Site | Oakland California, United States, 94611Research Site | New Haven Connecticut, United States, 06510Research Site | Stuart Florida, United States, 34994Research Site | Gainesville Georgia, United States, 30501Research Site | Chicago Illinois, United States, 60637Research Site | Baltimore Maryland, United States, 21201Research Site | Baltimore Maryland, United States, 21231Research Site | Boston Massachusetts, United States, 02215Research Site | Saint Louis Park Minnesota, United States, 55426Research Site | Omaha Nebraska, United States, 68124Research Site | Buffalo New York, United States, 14263Research Site | Cleveland Ohio, United States, 44195Research Site | Pittsburgh Pennsylvania, United States, 15212Research Site | Chattanooga Tennessee, United States, 37404Research Site | Memphis Tennessee, United States, 38120Research Site | Nashville Tennessee, United States, 37203Research Site | Nashville Tennessee, United States, 37203Research Site | Nashville Tennessee, United States, 37232Research Site | Houston Texas, United States, 77030Research Site | Houston Texas, United States, 77090Research Site | Fairfax Virginia, United States, 22031Research Site | Edmonds Washington, United States, 98026Research Site | Seattle Washington, United States, 98104Research Site | Ghent , Belgium, 9000Research Site | Ghent , Belgium, 9000Research Site | Gilly , Belgium, 6060Research Site | Leuven , Belgium, 3000Research Site | Roeselare , Belgium, 8800Research Site | Edmonton Alberta, Canada, T6G 1Z2Research Site | Winnipeg Manitoba, Canada, R3E 0V9Research Site | Montreal Quebec, Canada, H2W 1S6Research Site | Montreal Quebec, Canada, H2X 3E4Research Site | Avignon , France, 84902Research Site | Bobigny , France, 93009Research Site | Bordeaux , France, 33076Research Site | Limoges , France, 83000Research Site | Rennes , France, 35000Research Site | Rouen , France, 76031Research Site | Suresnes , France, 92150Research Site | Toulon , France, 83000Research Site | Kecskemét , Hungary, 6000Research Site | Székesfehérvár , Hungary, 8000Research Site | Tatabánya , Hungary, 2800Research Site | Törökbálint , Hungary, 2045Research Site | Dublin , Ireland, D07 R2WYResearch Site | Dublin , Ireland, D08 NHY1Research Site | Dublin , Ireland, D09 V2N0Research Site | Galway , Ireland, H91 YR71Research Site | Aviano , Italy, 33081Research Site | Brescia , Italy, 25123Research Site | Catanzaro , Italy, 88100Research Site | Florence , Italy, 50134Research Site | Genova , Italy, 16100Research Site | Meldola , Italy, 47014Research Site | Milan , Italy, 20162Research Site | Monza , Italy, 20900Research Site | Padova , Italy, 35128Research Site | Perugia , Italy, 06156Research Site | Pisa , Italy, 56124Research Site | Roma , Italy, 00144Research Site | Rozzano , Italy, 20089Research Site | Lisbon , Portugal, 1099-023Research Site | Lisbon , Portugal, 1169-050Research Site | Lisbon , Portugal, 1400-038Research Site | Lisbon , Portugal, 1500-650Research Site | Porto , Portugal, 4099-001Research Site | Porto , Portugal, 4100-180Research Site | Porto , Portugal, 4200-072Research Site | Busan , South Korea, 48108Research Site | Chungcheongbuk-do , South Korea, 28644Research Site | Seongnam-si , South Korea, 13496Research Site | Seoul , South Korea, 03080Research Site | Seoul , South Korea, 05505Research Site | Suwon , South Korea, 16247Research Site | Suwon , South Korea, 440-746Research Site | A Coruña , Spain, 15006Research Site | Alicante , Spain, 03010Research Site | Barcelona , Spain, 08036Research Site | Barcelona , Spain, 8035Research Site | Córdoba , Spain, 14004Research Site | Madrid , Spain, 28040Research Site | Majadahonda , Spain, 28250Research Site | Málaga , Spain, 29010Research Site | Reus , Spain, 43204Research Site | Seville , Spain, 41009Research Site | Terrassa , Spain, 08221Research Site | Valencia , Spain, 46010Research Site | Liuying , Taiwan, 736Research Site | New Taipei City , Taiwan, 235Research Site | Tainan , Taiwan, 70403Research Site | Taipei , Taiwan, 10002Research Site | Taipei , Taiwan, 11217Research Site | Ankara , Turkey (Türkiye), 06010Research Site | Ankara , Turkey (Türkiye), 06500Research Site | Ankara , Turkey (Türkiye), 06800Research Site | Istanbul , Turkey (Türkiye), 34722Research Site | Izmir , Turkey (Türkiye), 35575
Investigators
Principal Investigator: Tina Cascone, MD, MD Anderson Cancer Center Houston, TX 77030