NCT06162572|Active Not RecruitingPhase 1DMCFDA Drug

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase 1b/2, Multicenter, Open-label Platform Study of Select Immunotherapy Combinations in Adult Participants With Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) With High PD-L1 Expression

Servier Bio-Innovation LLC ClinicalTrials.gov

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1 other identifier

SPLFIO-174

Study Type

interventional

Target

100

Locations

13 countries

Sites

Timeline

RegisteredDec 2023

StartedAug 2024

CompletionJul 2027

Brief Summary

This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (RDE) for S095018, S095024, and S095029 in combination with cemiplimab and part B, the randomized dose expansion phase to assess the efficacy of S095018, S095024, or S095029 in combination with cemiplimab. Study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per iRECIST and/ or until meeting other treatment discontinuation criteria.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P75+ for phase_1

Timeline

14mo left

Started Aug 2024

Typical duration for phase_1

Geographic Reach

13 countries

60 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress60%

Aug 2024Jul 2027

First Submitted

Initial submission to the registry

November 29, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed

8 months until next milestone

Study Start

First participant enrolled

August 7, 2024

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

November 29, 2023

Last Update Submit

March 12, 2026

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (6)

Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment
Part A
Through the end of the Cycle 2 (each cycle is 21 days)
Incidence and severity of adverse events (AEs)
Part A
From the signed informed consent form (ICF) to 30 days after the last dose
Incidence and severity of serious adverse events (SAEs)
Part A
From the signed ICF to 120 days after the last dose
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Part A
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Adverse Events (AEs) Leading to Permanent Treatment Discontinuation
Part A
From signed ICF through treatment discontinuation (up to 108 weeks of treatment)
Objective Response (OR)
Part B: Participants who achieve complete response (CR) or partial response (PR), as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Until study termination (approximately 2 years)

Secondary Outcomes (16)

Objective Response (OR)
Until study termination (approximately 3 years)
Best Overall Response (BOR)
Until study termination (approximately 3 years)
Duration of Response (DoR)
Until study termination (approximately 3 years)
Disease Control (DC)
Until study termination (approximately 3 years)
6-month Durable Response (6-month DR)
Until study termination (approximately 3 years)
+11 more secondary outcomes

Study Arms (7)

S095018 (anti-TIM3 antibody) in combination with cemiplimab

EXPERIMENTAL

Part A: Combination-therapy safety lead-in

Drug: S095018Drug: Cemiplimab

S095024 (anti-CD73 antibody) in combination with cemiplimab

EXPERIMENTAL

Part A: Combination-therapy safety lead-in

Drug: S095024Drug: Cemiplimab

S095029 (anti-NKG2A antibody) in combination with cemiplimab

EXPERIMENTAL

Part A: Combination-therapy safety lead-in

Drug: S095029Drug: Cemiplimab

S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab

EXPERIMENTAL

Part B: Randomized dose expansion

Drug: S095018 Recommended Dose Expansion (RDE)Drug: Cemiplimab

S095024 (anti-CD73 antibody) RDE in combination with cemiplimab

EXPERIMENTAL

Part B: Randomized dose expansion

Drug: S095024 RDEDrug: Cemiplimab

S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab

EXPERIMENTAL

Part B: Randomized dose expansion

Drug: S095029 RDEDrug: Cemiplimab

Cemiplimab (control arm)

ACTIVE COMPARATOR

Part B: Randomized dose expansion

Drug: Cemiplimab