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Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

NCT06726265 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2026-03-18

No results posted yet for this study

Summary

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).

Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

Conditions

  • Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Interventions

BIOLOGICAL

eftilagimod alfa

30 mg of efti every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total

DRUG

carboplatin plus paclitaxel

For participants with squamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: carboplatin area under the curve (AUC) 5 or 6 in combination with paclitaxel 175 mg/m2 or 200 mg/m2

DRUG

cisplatin or carboplatin + pemetrexed

For participants with nonsquamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: cisplatin 75 mg/m2 or carboplatin AUC 5 or 6 in combination with pemetrexed 500 mg/m2. After the initial 4 cycles, pemetrexed 500 mg/m2 maintenance therapy will be administered every 3 weeks

BIOLOGICAL

pembrolizumab (KEYTRUDA®)

200 mg pembrolizumab (KEYTRUDA®) every 3 weeks i.v. for up to approximately 24 months

OTHER

Placebo

efti-matching placebo every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2027-06-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Georgia
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Poland
  • Portugal
  • Romania
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726265 on ClinicalTrials.gov