Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 95 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective several study drug combinations are when given with chemotherapy before and after surgery. It is for people with newly diagnosed non-small cell lung cancer that can be removed by surgery, from stage IIA to stage IIIB.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You have newly diagnosed non-small cell lung cancer, stage IIA to IIIB, that can be removed by surgery.
- You can do all usual activities or have trouble only with hard physical activity.
- Your organs and bone marrow, which makes blood cells, work well enough.
- You can provide a new tumor sample or one no more than 6 months old to test for PD-L1, EGFR, or ALK markers.
- Your lungs work well enough.
Who can't join
- Your cancer has certain EGFR or ALK gene changes, or is small-cell or mixed small-cell lung cancer. For study groups 6 and 7 only, a PD-L1 test result below 1% also excludes you.
- You have a history of another cancer, an immune system weakness, or an autoimmune or inflammatory illness, where the immune system may attack healthy tissue.
- You have current or suspected lung tissue inflammation, or previously had lung inflammation not caused by infection that needed steroids.
- You have an uncontrolled illness, significant heart disease, certain heart rhythm problems, active bleeding, or serious long-term gut problems with diarrhea. Mental health or social problems that prevent following study rules also exclude you.
- Your care plan includes radiation before surgery, or your surgeon thinks you need or may need removal of a whole lung, a lung segment, or a wedge-shaped piece of lung.
- You cannot safely receive chemotherapy, are receiving other cancer drug treatment, or previously received certain treatments that target the immune system or carry chemotherapy directly to cancer cells.
- You received a live, weakened vaccine within 30 days before the first study dose, or used medicine that lowers immune activity within 14 days before that dose.
- You have an active or uncontrolled infection, including the hepatitis infections listed in the study or HIV.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (25)
AR
- Research Site · Little Rock, AR 72205More trials in Little Rock
CA
- Research Site · Los Angeles, CA 90095More trials in Los Angeles
- Research Site · Oakland, CA 94611More trials in Oakland
CT
- Research Site · New Haven, CT 06510More trials in New Haven
FL
- Research Site · Stuart, FL 34994More trials in Stuart
GA
- Research Site · Gainesville, GA 30501More trials in Gainesville
IL
- Research Site · Chicago, IL 60637More trials in Chicago
MA
- Research Site · Boston, MA 02215More trials in Boston
MD
- Research Site · Baltimore, MD 21201More trials in Baltimore
- Research Site · Baltimore, MD 21231More trials in Baltimore
MN
- Research Site · Saint Louis Park, MN 55426More trials in Saint Louis Park
NE
- Research Site · Omaha, NE 68124More trials in Omaha
NY
- Research Site · Buffalo, NY 14263More trials in Buffalo
OH
- Research Site · Cleveland, OH 44195More trials in Cleveland
PA
- Research Site · Pittsburgh, PA 15212More trials in Pittsburgh
TN
- Research Site · Chattanooga, TN 37404More trials in Chattanooga
- Research Site · Memphis, TN 38120More trials in Memphis
- Research Site · Nashville, TN 37203More trials in Nashville
- Research Site · Nashville, TN 37203More trials in Nashville
- Research Site · Nashville, TN 37232More trials in Nashville
TX
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · Houston, TX 77090More trials in Houston
VA
- Research Site · Fairfax, VA 22031More trials in Fairfax
WA
- Research Site · Edmonds, WA 98026More trials in Edmonds
- Research Site · Seattle, WA 98104More trials in Seattle