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NCT03625323 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Immutep S.A.S..

Completed
Registry status
Phase 2
Development phase
187
Enrollment target

NCT03625323: Completed Phase 2 study, sponsored by Immutep S.A.S..

NCT03625323 is a Phase 2 study that has completed, run by Immutep S.A.S.. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03625323, a Phase 2 study, has completed, sponsored by Immutep S.A.S..

COMPLETED
Registry status
Phase 2
Development phase
187 participants
Enrollment target

Study 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.

Primary Outcome

ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline s

Interventions

  • DRUG pembrolizumab (KEYTRUDA®)
  • DRUG eftilagimod alpha

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2019-02-21
Est. Completion 2024-11-25
Phase Phase 2
Immutep S.A.S.

4 total trials

What the finished NCT03625323 record still lists

NCT03625323 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).

The record links to 0 conditions, and to 2 interventions - of which pembrolizumab (KEYTRUDA®) is the first listed.

NCT03625323 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03625323 about?

NCT03625323 is a clinical study titled "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". 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.

What is the current status of trial NCT03625323?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2019-02-21. Estimated completion is 2024-11-25.

What interventions are being tested in trial NCT03625323?

The interventions under investigation include: pembrolizumab (KEYTRUDA®) (DRUG), eftilagimod alpha (DRUG).

Who is sponsoring clinical trial NCT03625323?

This trial is sponsored by Immutep S.A.S., which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03625323's enrollment target sits among peer trials

187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03625323, the US trial registry maintained by the National Library of Medicine. NCT03625323 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.