A Phase 3 interventional study of Durvalumab and Placebo in Non-Small Cell Lung Cancer, sponsored by AstraZeneca. Active, not recruiting at 231 sites in 28 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 825 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms 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:
Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
Drug: Durvalumab · Drug: Carboplatin · Drug: Cisplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Gemcitabine · Procedure: Surgery
Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
Other: Placebo · Drug: Carboplatin · Drug: Cisplatin · Drug: Pemetrexed · Drug: Paclitaxel · Drug: Gemcitabine · Procedure: Surgery
1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Also known as: MEDI4736
Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Time frame: Up to approximately 15 weeks after randomization
Event-Free Survival (EFS) in modified intent to treat (mITT) population
An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Time frame: Up to 5.5 years after first patient randomized.
Disease-free survival (DFS) in modified resected population
Time frame: From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
Time frame: From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time frame: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Time frame: From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood
To assess concentration of durvalumab in bloodstream.
Time frame: From date of randomization to 2 months after resection
Presence of ADA for durvalumab
To evaluate the presence of antibodies following treatment with study medications.
Time frame: From date of randomization to 3 months after last dose of IP
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: From date of randomization to 3 months after last dose of IP
Showing the first 100 of 231 sites across 28 countries.
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 shared.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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