Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (TACTI-002)
TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)
Sponsor: Immutep S.A.S.
This observational or N/A phase trial investigates HNSCC and NSCLC and is currently completed. Immutep S.A.S. leads this study, which shows 23 recorded versions since 2019 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Up to 187 patients will be recruited in the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 22 study centres in the U.S., Europe and Australia. It will evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in patients with advanced or metastatic non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. eftilagimod alpha dosing every 2 or 3 weeks.
Up to 187 patients will be recruited in the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 22 study centres in the U.S., Europe and Australia. It will evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in patients with advanced or metastatic non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. eftilagimod alpha dosing every 2 or 3 weeks.
Status Flow
Change History
23 versions recorded-
Apr 23, 2026 — Present [daily]
Completed
Phase: PHASE2 → None
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Jan 2025 — Apr 2026 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Sep 2024 — Jan 2025 [monthly]
Active Not Recruiting PHASE2
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Nov 2023 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
▶ Show 18 earlier versions
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Jan 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE2
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Jul 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE2
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Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
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Mar 2022 — Jun 2022 [monthly]
Active Not Recruiting PHASE2
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Jan 2022 — Mar 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Nov 2021 — Jan 2022 [monthly]
Recruiting PHASE2
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Oct 2021 — Nov 2021 [monthly]
Recruiting PHASE2
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May 2021 — Oct 2021 [monthly]
Recruiting PHASE2
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Feb 2021 — May 2021 [monthly]
Recruiting PHASE2
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Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
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Jul 2020 — Jan 2021 [monthly]
Recruiting PHASE2
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Feb 2020 — Jul 2020 [monthly]
Recruiting PHASE2
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Aug 2019 — Feb 2020 [monthly]
Recruiting PHASE2
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Apr 2019 — Aug 2019 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Mar 2019 — Apr 2019 [monthly]
Not Yet Recruiting PHASE2
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Feb 2019 — Mar 2019 [monthly]
Not Yet Recruiting PHASE2
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Oct 2018 — Feb 2019 [monthly]
Not Yet Recruiting PHASE2
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Sep 2018 — Oct 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.
Contact Information
- Immutep S.A.S.
- Merck Sharp & Dohme LLC
For direct contact, visit the study record on ClinicalTrials.gov .