A Phase 2 interventional study of Durvalumab in Non-small Cell Lung Cancer, sponsored by AstraZeneca. Active, not recruiting at 49 sites in 11 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
This will be a multicentre, Phase II, single-arm, global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
Neoadjuvant Period A:
All participants will initially receive 2 cycles of neoadjuvant durvalumab + CT (investigator's choice platinum-based) every three weeks. Participants will be assessed for resectability by a multidisciplinary team.
Neoadjuvant Period B:
Cohort 1: Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles, followed by surgery.
CRT:
Cohort 2: Participants with unresectable tumours (according to MDT re-assessment) will receive definitive CRT (6 one-week cycles) for approximately six weeks.
Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 142 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Durvalumab will be administered to the participants via intravenous infusion (IV)
Drug: Durvalumab
Participants that go on to receive surgery, will receive durvalumab for up to four cycles prior to surgery. Participants that go on to receive CRT will receive durvalumab for up to two cycles prior to CRT. All participants will receive durvalumab every four weeks until disease progression or recurrence or up to 12 months following surgery/CRT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Also known as: MEDI4736
Resection rate
Resection rate is defined as the proportion of all participants who underwent definitive surgery. Participants who undergo (ie, start) surgery with the goal of complete tumour resection will be counted as meeting this endpoint.
Time frame: At day of surgery (Within 40 days of the last dose of neoadjuvant treatment)
Resection rate
Resection rate will be further assessed separately in participants deemed resectable at baseline and participants deemed borderline resectable at baseline.
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
R0, R1, R2 resection rates
The R0, R1, and R2 resection rates (assessed separately) are defined as the proportion of resected participants with resection margins assessed as R0, R1, and R2 respectively. R0 corresponds to resection for cure or complete remission, R1 to microscopic residual tumour, R2 to macroscopic residual tumour.
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Pathological complete response (pCR)
pCR will be defined as the proportion of participants who undergo surgery and have 0% residual viable tumour cells in resected lung and lymph nodes.
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Overall Survival (OS)
OS will be defined as the time from first dose of study intervention until the date of death due to any cause.
Time frame: From first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Overall Survival (OS) rate
The proportion of participants alive at 12 and 24 months.
Time frame: At 12 months and 24 months
Event-free survival (EFS)
EFS is defined as the time from the first dose of study intervention to any of the following events: PD that precludes surgery, progression or recurrence of disease after surgery, PD in the absence of surgery, disease progression, recurrence, or death due to any cause.
Time frame: From first dose of study intervention until progression of disease (PD), recurrence or death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Event-free survival (EFS) rate
The proportion of participants alive and event-free at 12 and 24 months.
Time frame: At 12 months and 24 months
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study intervention to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.-defined PD, as assessed by the investigator, or death due to any cause.
Time frame: From first dose of study intervention until disease progression, death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Progression Free Survival (PFS) rate
The proportion of participants alive without disease progression at 12 and 24 months.
Time frame: At 12 months and 24 months
Objective response rate (ORR) pre-surgery/pre-chemoradiotherapy (CRT)
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
Time frame: From first dose of study intervention until death, surgery/start of CRT
ORR during study intervention and definitive CRT
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
Time frame: From MDT re-assessment timepoint (baseline for this endpoint) until the first tumour assessment after definitive CRT
Percentage of all participants with circulating tumor DNA (ctDNA) clearance
Circulating tumour DNA clearance (ie, cMR) will be defined as a change from detectable ctDNA to undetectable ctDNA (ctDNA concentration less than limit of detection) at specified timepoints. The percentage of all biomarker-evaluable participants with ctDNA clearance will be assessed.
Time frame: From Cycle 1 Day 1 up to pre-surgery/CRT (within 7 to 14 days pre-surgery/CRT) [Each cycle is of 3 weeks]
Number of participants with adverse events
Safety and tolerability will be evaluated in terms of adverse events and serious adverse events.
Time frame: From enrollment up to at least 90 days after last dose of study intervention
Surgical safety: Duration of surgical procedure
The safety of study intervention will be evaluated from start to end of surgery
Time frame: Time from start of surgery to end of surgery
Surgical safety: Length of post operative hospital stay
The safety of study intervention will be evaluated during post operative hospital stay
Time frame: Time from the beginning of the surgery/procedure to the discharge of hospital
Surgical safety: Intended surgical approach
Intended surgical approach at baseline (minimally invasive vs open thoracotomy).
Time frame: At baseline
Surgical safety: Actual surgical approach
Actual surgical approach (minimally invasive vs open thoracotomy).
Time frame: At surgery
Surgical safety: Intended surgical procedure
Intended surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy).
Time frame: At baseline
Surgical safety: Actual surgical procedure
Actual surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy)
Time frame: At surgery
Number of participants with delayed surgery
The safety of study intervention will be evaluated for participants with delayed surgery
Time frame: 40 days after last dose of study intervention to surgery
Surgical safety: Length of surgical delays
The safety of study intervention will be evaluated during the length of the surgical delay
Time frame: 40 days after last dose of study intervention to surgery
Number of participants with reason of surgical delay
The safety of study intervention will be evaluated for participants with reason of surgical delay
Time frame: 40 days after last dose of study intervention to surgery
Time from last neoadjuvant dose to surgery
The safety of the study intervention will be evaluated from last neoadjuvant dose to surgery
Time frame: Time from last neoadjuvant dose of study intervention to surgery
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies-sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Carcinoma, Non-Small-Cell Lung→
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