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Assessing durvalumab and chemotherapy for lung cancer treatment

A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)

Phase 2 Interventional AstraZeneca · NCT05925530

This study is testing if a new combination of a drug called durvalumab and chemotherapy can help people with certain types of lung cancer before surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab, chemotherapy
Locations70 sites (Duarte, California and 69 other locations)
Trial IDNCT05925530 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of neoadjuvant durvalumab combined with platinum-based chemotherapy in patients with resectable or borderline resectable stage IIB-IIIB non-small cell lung cancer (NSCLC). Participants will receive two cycles of this treatment, followed by either surgery with adjuvant durvalumab or chemoradiotherapy and consolidation durvalumab. The study is multicenter and single-arm, meaning all participants will receive the same treatment without a control group. The goal is to determine the best approach to improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with resectable or borderline resectable stage IIB-IIIB NSCLC who have not received prior treatment.

Not a fit: Patients with unresectable NSCLC or those with stage IIIC disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
* Previously untreated and pathologically confirmed Stage IIB to select \[i.e.N2\] Stage IIIB by AJCC v8.
* Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
* Mandatory brain MRI.
* EGFR and ALK wild-type.
* Medically operable: adequate cardiac and lung function to undergo resection.
* Participant must be ≥ 18 years, at the time of screening.
* Histologically or cytologically documented NSCLC.
* Minimum life expectancy of 12 weeks.
* Minimum body weight of 30 kg.
* Male and female participants must be willing to use acceptable methods of contraception.
* Female participants of childbearing potential must have negative pregnancy test.

Exclusion Criteria:

* Unresectable NSCLC confirmed by MDT evaluation at baseline
* Stage IIIC patients
* Participants whose planned surgery at enrollment is a wedge resection
* Known EGFR mutation or ALK translocation
* Participants contraindicated for surgical intervention due to comorbid conditions
* Participants who are allergic to study intervention.
* Participants with more than one primary tumour.
* Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening.
* Female participants who are pregnant or breastfeeding.
* Judgement by the investigator that the participant should not participate in the study.
* Previously infected or tested positive for human immunodeficiency virus.

Where this trial is running

Duarte, California and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerNeoadjuvantDurvalumabChemoradiotherapySurgeryAdjuvantConsolidationMultidisciplinary team
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.