Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Misty Shields
Study ID
NCT07153055
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Small Cell Lung Cancer ( SCLC )
  • Transformed Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    Two 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 — DRUG
    Two osimertinib does of 80 mg or 40 mg orally once daily, as assigned by the dose de-escalation cohort for each 21 day cycle.

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Does De-Escalation
    3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.
  • Experimental: Phase II Dose Expansion
    3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.

Primary Outcome Measure

Grade 3 or dose-limiting toxicities [ Time Frame: Within 30 days after your last dose of study treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202

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Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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