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
Qualifiers
≥ 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
Treatments tested in this trial
- Lurbinectedin
- Osimertinib
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov