Trial Outcomes & Findings for Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy. (NCT NCT04642469)

Last Updated: 2024-06-25

Results Overview

DFS was defined as the time from the date of randomization until any one of the following events, whichever occurred first: Date of disease recurrence using Investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 OR Date of death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months

Results posted on

2024-06-25

Participant Flow

This Phase III multicenter, double-blind, placebo-controlled study was conducted in participants with Stage II to III non-small cell lung cancer (NSCLC) at 21 sites in 13 countries (Australia, Brazil, Czech Republic, France, Greece, Hungary, Israel, Italy, Japan, Spain, Taiwan, Turkey, and United States). First participant was enrolled on 30-Nov-2020 and final data cut-off (DCO) date was 31 May 2023.

30 participants were randomized in a 1:1 ratio to receive durvalumab monotherapy or placebo in the study.

Participant milestones

Participant milestones
Measure	Durvalumab Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study STARTED	15	15
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study Failure to meet inclusion/exclusion criteria	1	0
Overall Study Death	1	2
Overall Study Study/site closed following amendment 1	11	11
Overall Study Other	1	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab n=15 Participants Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=15 Participants Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Total n=30 Participants Total of all reporting groups
Age, Continuous	59.3 Years STANDARD_DEVIATION 8.6 • n=5 Participants	66.7 Years STANDARD_DEVIATION 10.3 • n=7 Participants	63.0 Years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months

Population: The FAS included all randomized participants.

Outcome measures

Outcome measures
Measure	Durvalumab n=15 Participants Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=15 Participants Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Disease-free Survival (DFS)	3.9 Months Interval 3.515 to NA indicates that upper limit of confidence interval was not estimable due to insufficient number of participants with events at study closure and due to limited duration of follow-up.	2.0 Months Interval 1.643 to 3.91

SECONDARY outcome

Timeframe: From start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months

Population: The Safety Analysis Set included all randomized participants who received any amount of study treatment.

An adverse event was any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was an AE that occurred during any study phase and fulfilled one or more of the following criteria: Resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, was an important medical event that might jeopardize the participant or might require medical treatment to prevent one of the outcomes listed above, AEs for malignant tumors reported during a study, malignant tumors that - as part of normal, if rare, progression - underwent transformation.

Outcome measures

Outcome measures
Measure	Durvalumab n=14 Participants Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=15 Participants Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AEs	13 Participants	10 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAEs	1 Participants	1 Participants

Adverse Events

Durvalumab

Serious events: 1 serious events

Other events: 13 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab n=14 participants at risk Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion over 60 minutes, once every 4 weeks (q4w) for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=15 participants at risk Participants received matching placebo via IV infusion over 60 minutes, once q4w for a maximum of 26 cycles, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Hepatobiliary disorders Autoimmune hepatitis	7.1% 1/14 • Number of events 1 • Treatment emergent Adverse events (TEAEs) were collected from start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months. All-cause mortality was collected from start of randomization (Day 0) up to completion of study, approximately 30 months. The Safety Analysis Set included all randomized participants who received any amount of study treatment. All-cause mortality was reported in FAS.	0.00% 0/15 • Treatment emergent Adverse events (TEAEs) were collected from start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months. All-cause mortality was collected from start of randomization (Day 0) up to completion of study, approximately 30 months. The Safety Analysis Set included all randomized participants who received any amount of study treatment. All-cause mortality was reported in FAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/14 • Treatment emergent Adverse events (TEAEs) were collected from start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months. All-cause mortality was collected from start of randomization (Day 0) up to completion of study, approximately 30 months. The Safety Analysis Set included all randomized participants who received any amount of study treatment. All-cause mortality was reported in FAS.	6.7% 1/15 • Number of events 1 • Treatment emergent Adverse events (TEAEs) were collected from start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months. All-cause mortality was collected from start of randomization (Day 0) up to completion of study, approximately 30 months. The Safety Analysis Set included all randomized participants who received any amount of study treatment. All-cause mortality was reported in FAS.

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place