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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNerviano Medical Sciences

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Current enrollment in another interventional clinical trial.

Current treatment with other anticancer agents or devices.

Major surgery, other than surgery for recurrent SCLC, within 4 weeks prior to treatment start.

Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.

Trial design

Treatments tested in this trial

  • NMS-03305293
  • Temozolomide

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators