Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer

Phase 1

Not yet recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: NMS-03305293; Drug: Temozolomide

• Registration Number: NCT06931626
• Lead Sponsor: Nerviano Medical Sciences

Brief Summary

This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-30
• Primary Completion: 2026-11-27
• Study Completion: 2026-11-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NMS-03305293 and Temozolomide	NMS-03305293	NMS-03305293 will be dosed orally on days 1-28 of each 28-day cycle, at 100 mg twice daily. Temozolomide will be dosed orally on days 1-5 of each 28-day cycle, at 150 mg/m\^2, based on patients' body surface area.
NMS-03305293 and Temozolomide	Temozolomide	NMS-03305293 will be dosed orally on days 1-28 of each 28-day cycle, at 100 mg twice daily. Temozolomide will be dosed orally on days 1-5 of each 28-day cycle, at 150 mg/m\^2, based on patients' body surface area.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 12 months)	Evaluation of type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 5.0), duration of AEs, electrocardiogram (ECG) and laboratory abnormalities

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From the date of first response up to data cut-off (approximately 12 months)	Calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), complete response (CR) or partial response (PR) through Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Duration of response (DoR)	From the date of first response up to data cut-off (approximately 12 months)	Duration of response will be calculated from the date of either first CR or PR until the date of documented progression for patients who achieved CR or PR. Patients who died without report of progression will be considered non-events and censored at their last disease-free assessment date
Progression-free survival (PFS)	From the date of treatment initiation up to data cut-off (approximately 12 months)	Progression Free Survival will be calculated from the date of treatment initiation to the date of first documentation of disease progression, or death due to any cause, whichever occurs first
Overall survival (OS)	From the date of treatment initiation up to data cut-off (approximately 12 months)	Overall Survival will be calculated from the date of treatment initiation to the date of death due to any cause
Maximum plasma concentration (Cmax) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Average plasma concentration (Cave) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Time to maximum plasma concentration (Tmax) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Area under the plasma concentration versus time curve up to the last detectable concentration (AUC) for NMS-03305293	Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Minimum plasma concentration (Cmin) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Area under the plasma concentration versus time curve to infinity (AUCinf) for NMS-03305293	Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Terminal elimination half-life (t1/2) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Oral plasma clearance (CL/F) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Apparent volume of distribution (Vd/F) of NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Accumulation ratio (Rac) of Cmax for NMS-03305293	Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Rac of Area under the plasma concentration vs time curve within dosing interval (AUCdaily) for NMS-03305293	Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Rac of Area under the plasma concentration up to the last detectable plasma concentration (AUClast) for NMS-03305293	Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days