Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Small Cell Lung Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed extensive-stage Small Cell Lung Cancer (SCLC); must have failed prior front-line platinum-based therapy including immune therapy with relapse within 6 months followed by failed tarlatamab therapy, if available and appropriate, and no more than 3 total prior lines of systemic therapy (therapy terminated due to toxicity or drug shortage, in the absence of Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression, will be considered part of the same line). Sponsor may opt to allow history of treatment free interval from front-line longer than 6 months .

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

• Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by RECIST v1.1 (radiologically measured by the Investigator).

• The interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever longer.

• All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or to the baseline laboratory values as defined in the protocol.

• Patients must use highly effective contraception or true abstinence.

• Ability to swallow capsules intact (without chewing, crushing, or opening).

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tennessee
Tennessee Oncology, PLLC
RECRUITING
Nashville
Contact Information
Primary
Domenico Roberti
clinicaltrials@nervianoms.com
+39 0331-581111
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 10
Treatments
Experimental: NMS-03305293 and 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.
Sponsors
Leads: Nerviano Medical Sciences

This content was sourced from clinicaltrials.gov