Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTubulis GmbH
About this trial
The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with unresectable or metastatic non-small cell lung cancer (NSCLC).
The primary objectives of this study are to determine the safety and tolerability and effectiveness of TUB-040, and/or recommended Phase 2 dose (RP2D).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults, male or nonpregnant, nonbreastfeeding female, age ≥18 years at the date of consent.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Documented radiographic progression on or after the most recent line of anticancer therapy.
Life expectancy of more than 12 weeks for disease-related mortality as evaluated by the INV.
Disqualifiers
Mixed histology NSCLC (eg, small cell lung cancer/NSCLC) or histology other than adenocarcinoma
Prior pneumonectomy
Newly identified or known unstable brain metastases, spinal cord compression, active CNS disease, progressive multifocal leukoencephalopathy, and/or carcinomatous meningitis.
Pregnant, lactating, or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
TUB-040
DrugAdministered IV
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: NSCLC Dose 1Experimental treatment 1 intervention
Group B: NSCLC Dose 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame
From enrollment until 30 days after last dose of study drug2
Overall Response Rate (ORR)
Assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 as assessed by the investigator (INV)
Time frame
Enrollment until approximately 80 days since last dose of study drugSecondary outcomes
1
Duration of response (DoR)
Duration of response (DoR) by RECIST v1.1 as assessed by the INV
Time frame
Up to approximately 24 months2
Disease control rate (DCR)
Disease control rate (DCR) by RECIST v1.1 as assessed by the INV
Time frame
Up to approximately 24 months3
Progression-free survival (PFS)
Progression-free survival (PFS) by RECIST v1.1 as assessed by the INV
Time frame
Up to approximately 24 months4
Overall survival (OS)
Overall survival (OS)
Time frame
Up to approximately 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: