TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy.

Conditions

Advanced/metastatic non-small cell lung cancer (NSCLC)

Brief summary

Overall survival (OS) is defined as the time from randomization to death from any cause., PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), defined as the time from randomization to documented disease progression or death from any cause as assessed by the Investigator assessment based on RECIST.

Detailed description

ORR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have best overall confirmed response (BOR) of complete response (CR) or partial response (PR)., Frequency, severity, and duration of adverse events (AEs), and clinically relevant abnormalities in vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and safety laboratory assessments., DCR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have BOR of confirmed CR or confirmed PR or stable disease (SD) (for ≥ 6 weeks)., DOR is defined as the time from the date a response of confirmed CR or confirmed PR was first documented until the date of the first documentation of disease progression., TTR is defined as the time from the date of first treatment to the date of the first documented confirmed CR or confirmed PR., TTNT defined from the date of randomization to the date of any post-trial procedure or therapy for the same disease., Changes from baseline in QoL as assessed by European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30); EORTC QLQ-LC13 and EuroQol 5 Dimension 5 Level (EQ-5D-5L)., PFS2 defined as the time from randomization to disease progression or death from any cause (whichever occurs first) on next-line treatment.

Related papers

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Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPACLITAXEL

DRUGCISPLATIN

DRUGCARBOPLATIN

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

DRUGIMP321

DRUGEfti-matching placebo (placebo is matching the appearance and injection characteristics of efti but does not contain active substance).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) is defined as the time from randomization to death from any cause., PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), defined as the time from randomization to documented disease progression or death from any cause as assessed by the Investigator assessment based on RECIST.	—

Secondary

Measure	Time frame
ORR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have best overall confirmed response (BOR) of complete response (CR) or partial response (PR)., Frequency, severity, and duration of adverse events (AEs), and clinically relevant abnormalities in vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and safety laboratory assessments., DCR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have BOR of confirmed CR or confirmed PR or stable disease (SD) (for ≥ 6 weeks)., DOR is defined as the time from the date a response of confirmed CR or confirmed PR was first documented until the date of the first documentation of disease progression., TTR is defined as the time from the date of first treatment to the date of the first documented confirmed CR or confirmed PR., TTNT defined from the date of randomization to the date of any post-trial procedure or therapy for the same diseas	—

Measure

Time frame

ORR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have best overall confirmed response (BOR) of complete response (CR) or partial response (PR)., Frequency, severity, and duration of adverse events (AEs), and clinically relevant abnormalities in vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and safety laboratory assessments., DCR according to RECIST 1.1 by Investigator assessment defined as the proportion of participants who have BOR of confirmed CR or confirmed PR or stable disease (SD) (for ≥ 6 weeks)., DOR is defined as the time from the date a response of confirmed CR or confirmed PR was first documented until the date of the first documentation of disease progression., TTR is defined as the time from the date of first treatment to the date of the first documented confirmed CR or confirmed PR., TTNT defined from the date of randomization to the date of any post-trial procedure or therapy for the same diseas

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Countries

Austria, Belgium, Bulgaria, Croatia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Spain

Outcome results

None listed