Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMisty Shields
About this trial
This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old at the time of informed consent.
Ability to provide written informed consent and HIPAA authorization.
Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer.
Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimertinib, and does not demonstrate evidence of acquired molecular underpinnings (i.e., presence of a MET amplification >6 copies or EGFR C797S) resulting in progression on osimertinib, aside from histologic transformation to small cell lung cancer. Interruptions of osimertinib prior to enrollment on study is permitted.
Disqualifiers
Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC.
Patients who are pregnant (treatment can cause fetal harm) and/or breastfeeding.
Symptomatic or unstable brain metastases, requiring > 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment.
Patients with known history of interstitial lung disease (ILD) or pneumonitis (> grade 1) or ILD/pneumonitis (> grade 1) related to antineoplastic drug treatment.
Trial design
Design model
Sequential
Treatments tested in this trial
Lurbinectedin
DrugTwo lurbinectedin does of 3.2 mg/m2 or 2.6 mg/m2. The initial starting dose is 3.2 mg/m2. Patients will receive lurbinectedin, until disease progression or unacceptable toxicity, once every 21 days.
Osimertinib
DrugTwo osimertinib does of 80 mg or 40 mg orally once daily, as assigned by the dose de-escalation cohort for each 21 day cycle.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Phase I Does De-EscalationExperimental treatment 2 interventions
Group B: Phase II Dose ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Grade 3 or dose-limiting toxicities
The number of incidences of grade 3 or dose-limiting toxicities of the combination of lurbinectedin with osimertinib assessed using NCI CTCAE v5.0 criteria.
Time frame
Within 30 days after your last dose of study treatment.Secondary outcomes
1
Progression-free survival
The average length of time of progression-free survival (PFS) of the combination of lurbinectedin with osimertinib.
Time frame
Within 30 days after your last dose of study treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov