Trial · NCT03625323

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

NCT03625323, Phase 2, Completed, Immutep S.A.S.; results first posted 2024-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT03625323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03625323

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT03625323
Status: Completed
Phases: Phase 2
Enrollment: 187 participants, actual
Lead sponsor: Immutep S.A.S.
Conditions: NSCLC, HNSCC
Interventions: eftilagimod alpha, pembrolizumab (KEYTRUDA®)
First posted: 2018-08-10
Last updated: 2026-04-22
Other registries' IDs: eudract:2018-001994-25
Results first posted: 2024-12-18

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)	Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months	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 sum of the diameters.
Primary	Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)	Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months	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 sum of the diameters.
Secondary	Duration of (Serious) Adverse Events	up to 27 months
Secondary	Frequency of (Serious) Adverse Events	up to 27 months
Secondary	Severity of (Serious) Adverse Events	up to 27 months
Secondary	Time to Responses According to iRECIST and RECIST 1.1	up to 68 months
Secondary	Duration of Responses According to iRECIST and RECIST 1.1	up to 68 months
Secondary	Response Rate According to RECIST 1.1	up to 68 months
Secondary	Disease Control Rate According to iRECIST and RECIST 1.1	up to 68 months
Secondary	Progression Free Survival (PFS)	up to 68 months

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)	Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)	Data collected from screening until time of disease progression, death, lost to follow up, study discontinuation, whichever occurs first, assessed up to approximately 68 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of (Serious) Adverse Events	up to 27 months
SECONDARY	Frequency of (Serious) Adverse Events	up to 27 months
SECONDARY	Severity of (Serious) Adverse Events	up to 27 months
SECONDARY	Time to Responses According to iRECIST and RECIST 1.1	up to 68 months
SECONDARY	Duration of Responses According to iRECIST and RECIST 1.1	up to 68 months
SECONDARY	Response Rate According to RECIST 1.1	up to 68 months
SECONDARY	Disease Control Rate According to iRECIST and RECIST 1.1	up to 68 months
SECONDARY	Progression Free Survival (PFS)	up to 68 months

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)	1st Line NSCLC	46	Participants
Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)	2nd Line NSCLC	3	Participants
Evaluation of Objective Response Rate (ORR) According to iRECIST (Unconfirmed)	HNSCC	11	Participants
Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)	1st Line NSCLC	40	Participants
Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)	2nd Line NSCLC	3	Participants
Evaluation of Objective Response Rate (ORR) According to iRECIST (Confirmed)	HNSCC	10	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1st Line NSCLC	114
Overall Study	STARTED	2nd Line NSCLC	36
Overall Study	STARTED	2nd Line HNSCC	37
Overall Study	COMPLETED	1st Line NSCLC	0
Overall Study	COMPLETED	2nd Line NSCLC	0
Overall Study	COMPLETED	2nd Line HNSCC	0
Overall Study	NOT COMPLETED	1st Line NSCLC	114
Overall Study	NOT COMPLETED	2nd Line NSCLC	36
Overall Study	NOT COMPLETED	2nd Line HNSCC	37

Source ClinicalTrials.gov

Adverse events498

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Asthenia	General disorders	1st Line NSCLC	37	114
other	Asthenia	General disorders	2nd Line NSCLC	8	36
other	Asthenia	General disorders	2nd Line HNSCC	8	37
other	Fatigue	General disorders	1st Line NSCLC	25	114
other	Fatigue	General disorders	2nd Line NSCLC	7	36
other	Fatigue	General disorders	2nd Line HNSCC	6	37
other	Pyrexia	General disorders	1st Line NSCLC	14	114
other	Pyrexia	General disorders	2nd Line NSCLC	2	36
other	Pyrexia	General disorders	2nd Line HNSCC	2	37
other	Oedema peripheral	General disorders	1st Line NSCLC	11	114

1 to 10 of 498Source ClinicalTrials.gov

See all 498 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1st Line NSCLC	14	114
Total, all-cause mortality	2nd Line NSCLC	2	36
Total, all-cause mortality	2nd Line HNSCC	7	37
Total, other adverse events	1st Line NSCLC	114	114
Total, other adverse events	2nd Line NSCLC	35	36
Total, other adverse events	2nd Line HNSCC	36	37
Total, serious adverse events	1st Line NSCLC	50	114
Total, serious adverse events	2nd Line NSCLC	7	36
Total, serious adverse events	2nd Line HNSCC	20	37

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39403626	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03625323

GET https://conductscience.org/api/trials/v1/NCT03625323/events?page=2

API reference For AI assistants