Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
ConditionSmall 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
NMS-03305293
DrugRoute of administration: Oral
Temozolomide
DrugRoute of administration: Oral Commercially available Temozolomide
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: NMS-03305293 and TemozolomideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
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
Time frame
Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 12 months)Secondary outcomes
1
Overall Response Rate (ORR)
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
Time frame
From the date of first response up to data cut-off (approximately 12 months)2
Duration of response (DoR)
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
Time frame
From the date of first response up to data cut-off (approximately 12 months)3
Progression-free survival (PFS)
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
Time frame
From the date of treatment initiation up to data cut-off (approximately 12 months)4
Overall survival (OS)
Overall Survival will be calculated from the date of treatment initiation to the date of death due to any cause
Time frame
From the date of treatment initiation up to data cut-off (approximately 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov