Phase 2 Completed N=189 Randomized Treatment

Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

Stage III non-small cell lung cancer · Unresectable

Source: ClinicalTrials.gov NCT03822351 ↗

Enrolled (actual)

189

Serious AEs

32.3%

Results posted

Oct 2024

Primary outcomePrimary: Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents — 23.9; 35.0; 40.3 Percentage of Participants

Summary

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	23.9; 35.0; 40.3	—
SECONDARY Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents	65; 57; 61; 23; 20; 17	—
SECONDARY Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents	1; 0; 0; 2; 0; 0	—
SECONDARY Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents	3; 3; 0; 2; 0; 3	—
SECONDARY Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	NA; 29.9; 23.0	—
SECONDARY Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	58.2; 80.0; 79.0	—
SECONDARY Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	7.3; 21.1; 19.8	—
SECONDARY Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	37.6; 63.5; 73.2	—
SECONDARY Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents	40.9; NA; NA	—
SECONDARY Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents	318.0; 277.4; 223.7; 59.7; 68.0; 74.3	—
SECONDARY Pharmacokinetics of Novel Agents in Combination With Durvalumab	581.6; 160.0; 216.4; 102.6; 124.5; 194.5	—
SECONDARY Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents	3; 1; 2; 1; 0; 0	—
SECONDARY Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab	0; 1; 0; 1; 0; 0	—

Eligibility Criteria

Main Inclusion Criteria:

Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
Age 18 years or older
Body weight ≥ 35 kg
Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study
Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
Life expectancy ≥ 12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1

Main Exclusion Criteria:

Mixed small cell and non-small cell lung cancer histology
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
Subjects with a history of venous thrombosis within the past 3 months
Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
Congestive heart failure
Active or prior documented autoimmune or inflammatory disorders
History of active primary immunodeficiency
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
History of allogenic organ transplantation
QTcF interval ≥ 470 ms
History of another primary malignancy
Concurrent enrollment in another clinical study [concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted]
Females who are pregnant, lactating, or intend to become pregnant during their participation in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03822351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.